SANSA at) TORRENT PHARMACEUTICALS LIMITED DAHEJ SITE MASTER FILE (FORMULATION) MANUFACTURING UNIT Torrent Pharinaceuticals Limited Plot no. 2/104 to 106, Dahej SEZ Part-II, Taluka Vagra Dist. Bharuch, 392130, Gujarat, India Tel. No. +91-2641-261300 to 303 Fax No. +91-2641-261699 Website: http://www.torrentpharma.com Document No. : SMF/DF/10 Effective Date 0} 03] 19 Review Before Date | 06|03]20 _ REASON FOR REVISION CCF/DHF/2019/0200 (PR#33075) |_| Site Master File is revised to update the details as per reference change control form number Page No. :01TORRENT PHARMACEUTICALS LTD, DAHEJ rtorrent Restricted Circalation Wa? FHERTR Doe. No. : SMF/DE/10 APPROVAL OF SITE MASTER FILE SITE MASTER FILE ORAL SOLID DOSAGE. FORMULATION FACILITY [PageNo:20f30 | | Effective Date: O73 }19 ACTIVITY ‘NAME AND DESIGNATION SIGN AND DATE, Sereeaaee ‘Mr. SUDHIR SUTRAVE _ wy Wa, GM-Produetion Ve (Formulation and Warehouse) Mr. NIRAJ SHETH GM- Packaging (Formulation) * ‘apres Mr. DIPAK PATEL Qpu CREED Ey GM- Engincering (Formulation) onelit Dr. KISHOR KOSHE es 4 GM- Quality Control Mr. JV S SHANKAR 5 AGM- Quality Assurance Ke Gautier \ ___»_ | Formulation) Jv ot \o4 "| Dr. PURUSHOTTAM SUDELE, [oe GM - Quality (Formulation) ort Mt y l d RO THOLGER BY. Mr. HASMUKH PATEL Heep. = 7 Mat VP -Works ox/oslty PREPARED BY ‘CHECKED BY Anupam Kumar Mishra ‘Ujwal Bagad_ DESIGNATION Executive Assistant Manager ” SIGN. & DATE ane BE grosTORRENT PHARMACEUTICALS LTD, DAHES Restricted Cirealation SITE MASTER FILE | Page No.:3 of 30 | No. : SMF/DF/10 peORALSOLD DOSAGE eo orpalra TABLE OF CONTENTS _ [SR.NO. [TITLE PAGE NO. 1.0 | GENERAL INFORMATION ; 05 1.1 | Contact Information [05 1.2 | Authorized pharmaceutical manufacturing activity of site 07 13. | Any Other Manufacturing Activities carried out on the Site 07 [20 | QUALITY MANAGEMENT SYSTEM 7 2.1 | The Quality Management System of the manufacturer 07 2.2 | Release procedure of finished products | 8 | 23 | Management of suppliers and contractors oo | 24 — | Quality Risk Management (QRM) 7 09 2.5 | Product Quality Reviews 09 3.0 _ | PERSONNEL DETAILS 7 10 4.0 _ | PREMISES AND EQUIPMENT INFORMATION u 41 | Premises Hi 4.1.1 _ | Brief description of Heating, Ventilation and Air conditioning - 2 GAVAO) system 4.1.2 _| Brief description of Water systems “14 4.13 _| Brief description of other relevant utilities 16 42 | Equipment 7 4.2.1 | List of major production equipment and QC instrument with ertical pieces 7 42.2__| Brief description on cleaning and sanitation 7 4.2.3 _ | Description of GMP critical computer systems w7 42.4 | Qualification and calibration program 18 42.5 _| Planned preventive maintenance program 18 5.0 | DOCUMENTATION PRACTICES 9 6.0 | PRODUCTION OPERATIONS 20 6.1 | Type of products 20 62 _ | Process validation 20 [ PREPARED BY ___ CHECKED BY NAME ‘Anupam Kumar Mishra ‘Ujwal Bagad F DESIGNATION Executive ‘Assistant Manager i SIGN. & DATE wal KaTORRENT PHARMACE! (CALS LTD, DAHES ‘SITE MASTER FILE [ne No. SMEDFILO QRALSOUDDOSAGE |. Te Date: 077103113 SR. NO. TITLE : - PAGE NO. 63 | Material management and warehousing aah 7.0 | QUALITY CONTROL ACTIVITIES 2 39 | DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND _ RECALL PROCEDURE 8.1 _| Distribution arrangements and recording system B 82 | Complaints, product defects and Recalls B 9.0 | SELFINSPECTION PROGRAM. Ey 10.0 | ABBREVIATIONS © 25 11.0 _| HISTORY OF CHANGES 6 12.0 | LIST OF APPENDICES 30 Appendix-1 | Copy of valid manufacturing authorization Appendix-2 | List of Dosage Forms and type of products manufactured on site _ Appendix-3 | List of GMP inspections Appenilic-4(A) | List of Contract Manufacturers and contact details Appenilix-4(B) | List of Contract Laboratories and Contact details ‘Appendix-5(A) | Organizational Chart Appendix-5(B) | No of Employees engaged in different section of facility ‘Appendix-5(C) | Qualification, Experiences and Responsibilities of Key personnel Appendix-6 (A)| Layouts of production areas including material & personnel flows. Appendix-6 (B)| General flow charts of manufacturing processes of each product type “Appendix-7 (A)| Schematic Drawing of Water System Appendix-7 (B) | Schematic Drawing HVAC System (Classified Area) ‘Appendix-7 (C) | Schematic Drawing HVAC System (Unclassified Area) Appendis-8 | List of Major Production Equipment and Laboratory Instrument PREPARED BY ‘CHECKED BY NAME, ‘Anupam Kumar Mishra 7 Ujwal Bagad DESIGNATION | Executive ‘Assistant Manager SIGN. & DATE wk oh Or, ge 09TO PHARMACEUTICALS LTD, DAHEJ Restricted Circulation © SMF/DF SITE MASTER FILE Page No.: 5 of 30 Goan Doc. No. ni L 0m es “ me FORMULATION ACHLITY | Effective Date: ©7108 |19 1.0 GENERAL INFORMATION ‘Mls TORRENT PHARMACEUTICALS LIMITED (TPL) is a public limited company. It is one of the flagship companies of the Torrent Group which also has its major presence in the power generation, distribution and transmission. it is a dominant player in the therapeutic areas of cardiovascular (CV) and central nervous system (CNS) and has achieved significant presence in gastro-intestinal, diabetology, anti- infective and pain management segments. It has also forayed into the therapeutic segments of nephrology and oncology while also strengthening its focus'on gynaecology and pediatric segments. Right from pioneering position marketing in India to caming the sobriquet of ‘the ‘Company with the most first Iamches’, Torrent Pharma has always remained ahead of its competition. TPL is engaged in manufacturing of Active Pharmaceutical Ingredients (API) and various types of Formulation preparations. From the earlier days, TPL has come a long way with an annual tumover of around 58 Billion rupees. It is a force to reckon with, in the local as well as the intemational arena. Products ‘manufactured by TPL are marketed in India and exported to various countries across the world, ‘The company has its Head office located at Ahmedabad, which houses the Administration, Procurement, Finance, Marketing and Sales divisions. The company Has four other manufacturing facilities, located at Indrad (Gujarat), Baddi (Himachal Pradesh), Sikkim and Pithampur (Madhya Pradesh). Besides this, TPL has well- | equipped Research Centre situated at Bhat, Ahmedabad. Torrent Pharma acquired the branded domestic formulations business of Elder Pharmaceuticals in India and Nepal. The acquisition comprises a portfolio of 30 brands including market-leading brands in the Women's Healthcare, Pain Management, Wound Care and Nutraceuticals ‘therapeutic segments. The transaction will also involve the transfer of employees engaged in sales, marketing and operations of the India Business. 1.1 Contact information: ‘TPL Dakej is the new manufacturing site for manufacturing of APIs and Oral Solid Dosage formulation producis. NAME DESIGNATION SIGN. & DATEtorrent TORRENT PHARMACEUTICALS LTD, DAHES Restricted Circulation GAP Punmma Doe, No. : SMF/DF/10 ORAL SOLID DOSAGE SITE MASTER FILE Page No.: 6 of 30 9 FORMULATION FACILITY __Bllestve Date: 09103 The TPL Dahej plants approximately 60 Kms from Bharuch which isa district town situated on the national highway No.08. ‘TPL Dahej is about 260 Kms from Ahmedabad, Nearest Railway station is Bharuch and nearest airport is Vadodara, about 130 Kms. The plant is constructed as per CGMP norms. The entire plant lay out and building design is in line with green building principles for optimum energy efficiency. There is no polluting industry and environment in its surrouriding area, a) Name and Address: TORRENT PHARMACEUTICALS LTD. | SITE ADDRESS Torrent Pharmaceuticals Limited Plot no, Z/104 to 106, Dahej SEZ Part-I, Taluka Vagra, Dist. Bharuch, 392130 Gujarat, India | ‘Tel. No. +91 2641 261300 Fax No. +91 2641 261699 Data Universal Numbering system(D-U-N-S) : 864147745 FEI No.:3010228235 GPS Co-ordinates: 21°40'41.7"N_& 72°32'46.1"E REGD. OFFICE Off. Ashram Road, & CORPORATE Ahmedabad - 380 009. OFFICE, Gujarat, India Phone : General EPA BX : +91 79 26585090/3060 Fax : +91 79 26582100 TORRENT ‘Nr. Kanoria Hospital, RESEARCH Village Bhat, CENTRE Dist. Gandhinagar, | Pim : 382428 Gujarat, India Phone : +91 79 23969100, +91 79 23969124-34 Fax : +9179 23969135, b) Name and details of the key personnel Contact information including 24 hrs. contact telephones No. and mail ID of contact personnel are as follows: ‘Name and designation | Email id Contact No. Mr. Hasmukh Patel hasmukhpatel@torrentpharma.com | Office : +91 2641 261666 VP -Works +491 2641 291625 _ Mobile : +91 98 79 107903 Mr. Purushottam Sudele | purushotiamsudele@torrentpharma.cor| Office : +91 2641 261509 GM — Quality Assurance a ‘Mobile : +91 63 59 621224 PREPARED BY 7 NAME. ‘Anupam Kumar Mishra DESIGNATION Executive SIGN. & DATE wry oTORRENT PHARMACEUTICALS LTD, DAHES - Restricted Circulation | on rDEe SITE MASTER FILE 7 of 30 loc. No, : SMI \L SOLID DOSAGE FORMULATION FACILITY _ | Effective Date: OH0S119 12 Authorized Pharmaceutical Manufacturing Activities of the Site Manufacturing authorization/site licenses issued by the local statutory body, Food & Drugs Administration, Gujarat State are License No: G/25/2016 in Form No. 25 & G/28/1453 in Form No. 28 Site comprises of API and Formulation manufacturing facilities to manufacture various pharmaceutical products for nafional and international markets. Following Oral Solid Dosage forms are manufactured in the formulation facility. * Uncoated and Coated Tablets ‘+ Hard Gelatin capsules List of products to be manufactured at the site are as per Appendix - 2. This site is inspected and approved by Local GMP authorities and international regulatory authorities. The list of GMP inspections held at site since last $ years is attached as Appendix-3 1.3 Any other manufacturing activities carried out on site. Other than oral solid dosage formulation, manufacturing of API (Active Pharmaceuticals Ingredient) is carried out at the site in separate manufacturing blocks. The details are added in site master file of respective facility. Non-pharmaceutical manufacturing activity is not carried out at side. 2.0 QUALITY MANAGEMENT SYSTEM 2.1 The Quality Management System of the manufacturer Al the manufacturing activities are carried out as per laid down the procedure to comply with the cGMP requirements and thus ensuring safety, quality, and efficacy of products. ‘Quality Policy” of the firm is “We the employees of Torrent Pharmaceuticals Limited are committed to achieve excellence in quality standards of our pharmaceutical products that enhance customer satisfaction, mect applicable cGMP and global regulatory requirements. ‘To achieve this, we shall always strive to, ‘* Develop product that meet and exceed customer needs and expectations throughout product life cycle; ‘* Manufacture and deliver products that consistently meet our quality standards, On-time, every time; * Procure material and develop extemal providers who can consistently meet our quality and delivery requirements; * Provide and maintain a technologically superior manufacturing infrastructure and hygienic work environment that enhance quality; * Provide trainings at all Jevels, on an on-going basis, that facilitates in building a work culture towards quality enhancement, safety and continual improvement. All input material. vendors dre audited / evaluated initially and periodically by Corporate Quality Assurance department situated at Torrent Research Centre. Based on the evaluation, these vendors are incorporated in Approved Vendor list. The specifications of the APIs and excipients are established as per respective pharmacopoeia. __PREPARED BY ‘CHECKED BY NAME ‘Anupam Kumar Mishra z ‘Ujwal Bagad DESIGNATION : Executive Assistant Manager SIGN. & DATE Quins Br prs?TORRENT PHARMACEUTICALS LTD, DAHES Doc. No. : SMF/DF/10 | SITE MASTER FILE 5 ‘ORAL SOLID DOSAGE. eee FORMULATIONFACILITY _| Effective Date: 07 03119 All active raw materials are 100 % sampled and inactive raw materials are sampled as \N+1 or 3 containers (Which ever is greater) /established laid down procedures/as per respective regulatory guidelines. Differént packing materials are sampled YN+1 or 5 Units (Which ever is greater VN+5 or 10 Units (Which ever is greater) as required. Incoming raw materials and packing materials are tested as per their specifications and only approved materials are used for the production purposes. Alll products are evaluated against set standards and cGMP compliance before releasing them for distribution, by competent Quality Assurance personnel/Qualified Person. A change control system is established-and maintained to track and evaluate the impact for the changes made in facility, manufacturing equipment, manufacturing processes, analytical processes, documentations etc. ‘Validation Master Plan is maintained to ensure the validated state of facility, equipment and processes. Quality Assurance department controls the document distribution and retrieval. Internal Audit/Self-inspection procedure is available to monitor the effectiveness and applicability of the Quality Systems and as quality improvement Plan. Stability studies are carried out in line with ICH (International conference of harmonization) at accelerated, Long term and intermediate condition including Zone IVa and Zone IVb and WHO (World Health Organization) Guidelines along with country/ market / customer specific requirements. For any new product, the technology is transferred from Research Centre or any other location to the Plant. All relevant technology transfer documents like specifications, Master Formula Card, Analytical method validation, Master packing docket, ete. are provided by existing ‘manufacturing location or Torrent Research Center. Senior management has the’ ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the company. Periodically, a Quality Review Meeting of senior management is held in this respect, Release procedure of Finished Products © Aficr completion of batch manufacturing, batch records (BMR, BPR) and analytical records are reviewed by designated Quality assurance personnel. Compliance to defined manufacturing and packing procedures, GMP and other relevant details are ensured. © Quality Assurance reviews the analytical reports to ensure that these samples are analyzed as per specified analytical methods and results are meeting with the specifications. After complete review of all applicable documents, authorized person / Qualified Person certify that the manufacturing process has been performed according to GMP and issues release note for distribution and sale as per Ref SOP No. DFQA-019. Wherever applicable, compliance to marketing authorization, technical and regulatory requirement is also ensured before release of batches for distribution and sale. PREPARED BY _ CHECKED BY Z NAME ‘Anupam Kumar Mishra Ujwal Bagad DESIGNATION Executive ‘Assistant Manager SIGN. & DATE poly oP Oi, ox‘TORRENT PHARMACEUTICALS LTD, DAHES 7 Drie SITE MASTER FILE Ne of 30 oc. No, : SMI ORAL SOLID DOSAGE FORMULATION FACILITY —__| Effective Date: 003|19 23 24 2.5 Management of Suppliers and Contractors Suppliers/Manufacturers of starting materials and packaging materials are assessed and evaluated by Corporate Quality Assurance from Torrent Research Centre. Established procedures for qualification of suppliers for API, Excipients, KSM and packaging material are in place who can reliable supply raw and packaging material that meet established specification. Performance of suppliers is routinely monitored and on-site audits of suppliers are performed. Approved vendor lists are maintained and material is procured from approved vendors only. Transmitting animal Spongiform Encephalopathy (TSE) and Bovine Spongiform Encephalopathy (BSE) certificates are being received from suppliers to ensure that products manufactured are free from said risks. Competent team is accessing and evaluating suppliers to ensure that cGMP compliance at Vendor's facility is maintained to provide consistent quality supply of starting materials and packaging materials. ‘Samples of starting materials are sent to TPI.’s approved external contract testing laboratories, wherever required. These contract testing laboratories are approved by local statutory bodies and are equipped to meet our testing requirements. Sharing of responsibilities between Contract giver and Contract accepter are defined in ‘Technical Agreements between Torrent and outside laboratory. List of approved contract laboratories with their addresses, contact information are as per Appendix-4(B). In addition to this, Torrent Research Centre provides the Analytical and Technical support, whenever required about technical competency and for need of sophisticated instruments. Other services used on contract basis are House Keeping Services, Laundry Services, Pest and rodent control Services, Calibration / Validation Services, Few activities related to HVAC system, Transportation and Medical examination of employee. No services of Contract manufacturers are availed by this site are as per Appendix — 4(A). Quality Risk Management (QRM) Quality risk assessment is carried out as per ICH Q9 guideline for the assessment, control, ‘communication and review of risks to the quality of the drug substances as well as product across the product lifecycle, systems, utilities, facility and other associated aspects. The evaluation of risk to the quality is based on scientific knowledge and to arrive for mitigation plan for reduction of product quality risk. The potential failure mode and effect of failure modes are identified, analyzed and evaluated based on Quality risk management system so as to control the risk up to acceptable level. The risk reductions actions are taken to improve detectability of hazards and to reduce severity and probability of harms. Product Quality Reviews Annual Product Quality. Review is performed by quality assurance department to access consistent quality attributes of each product and to identify the scope of product and process PREPARED BY ‘CHECKED BY NAME ‘Anupam Kumar Mishra ‘Ujwal Bagad DESIGNATION _ Executive ‘Assistant Manager SIGN. & DATE wl falia Ces beTORRENT PHARMACEUTICALS LTD, DAHES [Ds No. : SMF/DE/10 SITE MASTER FILE ‘ORAL SOLID DOSAGE FORMULATION FACILITY | Effective Date: 034 03/19 _ | improvement. Annual product review and evaluation i caried out for all the batches ‘manufactured during the previous calendar year and documented as per written procedures. The Critical in-process parameters, analytical data are reviewed, evaluated and compiled for the preparation of PQR. PERSONNEL DETAILS ) Organogram of Production, Quality Unit and other supporting departments are as per Appendix-5(A). b) No. of employees engaged in different sections of facility are as per Appendix-5(B). Which inclides technical staff of relevant department. ©) Qualifications, Experiences and Responsibilities of Key Personnel are as per Appendix-5(C). 4) Training: Induction, Training needs identification, On Job training and records management. Induction training The training on recruitment covers relevant, aspects of Personal Hygiene, Sanitation’ and ‘gowning. The person is trained for basic CGMP, GLP, HSE and other company policies. Newly employed persons are trained by means of Classroom training and self reading for the SOP’s, GMP/ GLP module related to their activities prior to commencement of their actual job, Execution of the read SOP’s and trained related to their activities. ‘Training Need Identification Concemed department head evaluates the training need identification for individuals, based on relevance of the activity, knowledge as well as experiences, On Job Training These include various cGMP aspects, Quality system and departmental SOPs pertaining to individual's job requirements. A training matrix for the SOP related training is prepared so as to ensure that all the relevant persons performing assigned tasks are trained in their respective SOPs. The training is evaluated by the written Questionnaire, In house online training software is developed namied as “Training Management System” which ‘was in operation for handling and recording training and records in electronic format. Periodic CGMP training to all employees are imparted in-house or by extemal faculty. ©) Health requirement for personnel engaged in production : Prior to and during employment are ensured through medical examinations on periodic basis to ‘ensure that no person is affected by an infectious disease by qualified medical person. Personal Hygiene requirement including clothing: Entry through separate change room provided for manufacturing and packagirig areas. ‘To minimize the cross contamination all personne! required to wear clean appropriate uniforms including hair covering. - PREPARED BY _ CHECKED BY _ ‘Anupam Kumar Mishra ‘Ujwal Bagad DESIGNATION Executive ‘Assistant Manager im ‘SIGN. & DATE poly OE ows| ronment PHARMACEUTICALS LTD, DAHES. Doe. No. : SME/DE/10 SITE MASTER FILE ORAL SOLID DOSAGE FORMULATION FACILITY. Effective Date: 6 03)19 4.0 44 Employee wisc dedicated dresses are provided in sufficient numbers so to facilitate periodic change. Visitors are allowed to enter in manufacturing areas through visitor's change rooin after following gowning procedure. PREMISES AND EQUIPMENT INFORMATION Premises a) Short description of plant, size of plant and list of buildings ‘The plant is constructed with consideration of regulatory GMP norms. The total area of site is 275,726 m?. ‘The departments wise built up area are’as follows: 1) Small Batch Manufacturing Block (SBM) 5758 mi 2) Formulation Block-1(FB1) 27616 m* 3) Formulation Warehouse Block (FWH) 13760 m? 4) QC & QA Block 11138 m? b) Design, Construction and Finishes of Manufacturing blocks and warehouse : Formulation manufacturing facility consists of two blocks. One is small batch manufacturing (SBM), used for manufacturing of Exhibit/Validation/Submission batches and sinall commercial scale batches. Formulation Block-1(FB1) having large scale manufacturing facilities Total area is having manufacturing capacity of approximately 7000 million tablets and 500 million capsules. ‘Small batch manufacturing is two storied building situated at center of site. Ground floor is dedicated for production activities and the first floor is used as service area. Construction of lange scale manufacturing facility is on the same philosophy. The basic flooring in all the core manufacturing area is of vacuum dewatered concrete floor, coated with antifungal self levelled epoxy for easy and effective cleaning. In secondary packing area, the flooring is laid with mirror polished Kota stones to sustain the material movement load, Corridor flooring is made of dnti static vinyl flooring. ‘The basic civil work is designed by using heat resistant walls helping in maintaining the room conditions and keeping provisions for using day light without affecting GMP considerations, ‘The internal partitions in the production area are made up of epoxy powder coated double skin clean room panels, filled with high density rock woo! lamellas. The external walls are made of ‘bricks. The intemal surface of brick walls is painted with antifungal polyurethane paint. The exterior surface is painted with acrylic based weather protective elastomer paint. Windows are aluminum framed double glass window panels, flush mounted in the walls. All the edges and the comers are coved with epoxy so as to facilitate better cleanability. Doors are of galvanized powder coated iron type. well flushed having minimum or no crevices. Door openings are maintained on high pressure side. Facility is designed to ensure that repair and maintenance of utility services do not pose hazard {o the manufacturing operations. PREPARED BY CHECKED BY NAME ‘Anupam Kumar Mishra ‘Ujwal Bagad DESIGNATION Executive Assistant Manager SIGN. & DATE, wu sys} Os oatesrsd Lhe:[eee Seraeel || TORRENT PHARMACEUTICALS LTD, DAHES Restricted Circulation WAP FAITE | SITE MASTER FILE Page No.: 120f30 ORAL SOLID DOSAGE FORMULATION FACILITY Effective Date: 03119 Lighting, HVAC and Utility Systems are designed in such a way that there is no adverse effect on the medicinal products, directly or indirectly during their manufacturing, storage and packaging. Manufacturing Buildings are designed and equipped to ensure maximum protection against the entry of insects or other animals. Pest and rodent control systett is established and maintained through service contract with outside agency. Entry of unauthorized personnel in manufacturing, storage and quality blocks is restricted by | procedural control by means of biometric Access control or lock and key. | Production’ areas are provided with required area classifications, pressure differentials and environmental conditions to maintain quality during production activities. Man and Material entry / exit in each block are through primary change rooms and airlocks. For each processing area, separate material air lock and personal air lock are provided. ‘The gowning and de-gowning procedure for the entry in non-processing and processing area is defined. The furniture used in processing area is made up of stainless steel which is polished and cleanable. Highly toxic, hazardous and sensitizing materials are not handled, stored or used and hence no special storage areas for these categories of materials are required. Storage areas are provided with specific storage conditions as per material requirement. Lay out of facilities are as per attached Appendix-6 (A) 411 Brief Description of Heating, Ventilation and Air Conditioning (HVAC) System Air Handling Units ate fabricated in double skinned wall with PUF insulation infill and thermal break profile. Outer skin is GI powder coated. The AHUs are provided with Series of filters to keep the air clean and free of dust particles. For all processing area, dedicated AHU systems are installed. Return air risers are placed at ower level of wall partitions. Chilled and Hot water are circulated through respective coils installed in the AHUs for environment conditioning. ‘Separate dehumidification and humidification units are installed for specific processing area-as per requirement of RH Control. Room pressure and air low is maintsined and monitored to prevent contamination and cross contamination. Production Arca Classified area: AHU systems ate designed to have re-circulation, with approximately 10 % fresh air intake. Fresh ait is filtered through G3 grade filters and mix with return air from area (approximate 90 %) it mixing chamber. This mixed air then filtered through G4 grade filters'and is cooled and dchumidified / humidified (as required). After cooling, air is filtered through F7 grade filters and PREPARED BY NAME ‘DESIGNATION SIGN. & DATEQe] TORRENT PHARMACEUTICALS LTD, DAHEJS Restricted Circulation PHRMA ae SITE MASTER FILE Page No.: 13 of 30 Doe. No. : SMI ORAL SOLID DOSAGE. ri FORMULATION FACILITY Effective Date:.07/03] 19 is fed to respective rooms through terminally located H14 grade HEPA filter. A part of supply air is bled through bypass damper after the fan in AHU body purge through H13 grade HEPA filter as per design requirement. Clean and conditioned supply air picks up the room sensible and latent heat load and is sent back to air handling unit through low level return air risers after passing through coarse filter G4 filters located at plenum. For all processing area temperature is maintained between 15°C to'25°C or 35°C to 50°C and RH between (10% to 40 %) or (10 % to 60%) or (40% to 60%) as per process/product requirement. Airlocks are provided to maintain the differential pressure in all process area (not Jess than 15 Pascal). For processing areas, air changes per hour is maintained at not less than 20 and in non processing area it is maintained as required by heat load of the area. Unclassified Area: Fresh air intake is filtered through G3 grade filters and is mixed in mixing chamber with return air from respective areas. Mixed air is than filtered through G4 grade filters, which gets cooled & dehumidified (if required) on cooling coil and heated through hot water coil as applicable for. controlling temperature. and relative humidity. After conditioning, air is filtered through F7/FS grade filter followed by H10 grade HEPA filter (at plenum) and is fed to respective areas through terminally located diffuser and grill. A part of supply air which is in excess of requirement is bled through purge damper after the fan in AHU through H13 grade HEPA filter as per design requirement. The supply air picks up the room sensible and latent heat load and is sent back through retum air diffuser and grill for further conditioning of air. For unclassified areas temperature is maintained between 15°C to 25°C/as per room design specification. RH is maintained between (10% to 40%) or (10% to 60%) or (40% to 60%) as per process/product requirement. ‘Ventilation System: ‘Areas other than production and quarantine are provided with once through Ventilation system. Fresh air is supplied through Ventilation supply unit consisting of G4 Pre-filter, blower section, followed by FS grade final filter. Air is retumed through ventilation exhaust system, which passes through G4 grade pre filter. Warehouse, Quarantines and the QC sections These are provided with separate air handling systems. Raw material quarantine and approved storage arca are maintained at 2°C to 8°C, 15°C to 25°C / 15°C to 27°C/ 2342°C and RH 10% to 40 % / 10 to 60% / Between 40% to 60% as per room requirement. However Lower RH is maintained for RH sensitive Storage areas. Sampling of raw materials is carried out. undér reverse laminar airflow system. Primary Packaging material storage area is provided with an air handling system to provide the necessary conditions of temperature and relative humidity for its storage. Sampling of primary packing material is carried out under laminar air flow system. PREPARED BY : ‘CHECKED BY NAME ‘Anupam Kumar Mishra ‘Ujwal Bagad DESIGNATION Executive = Tasisant ‘Manager SIGN. & DATE puts atia Oe wie’| TORRENT PHARMACEUTICALS LTD, DAHES | Poe: No. : SMF/DE/10 ORAL SOLID DOSAGE ‘SITE MASTER FILE, _FORMULATION FACHLATY Date: 07]03) 9 Microbiology section in Quality Control area bas separate air-handling units, Media preparation room is classified as ISO7 in rest condition. Other testing areas in quality control are provided with Ductable and cassette type air conditioning units to maintain comfort cooling conditions. Fume hoods and Air scrubbing systems are provided in laboratory area as required. ‘The schematic diagram of HVAC system is attached as per Appendix-7 (B) and Appendiz-7 (C) for classified and unclassified area respectively. Brief Description of Water System a) Raw Water ‘Narmada river water received from GIDC reservoir is source of water for the site. This water is stored in underground buffer water storage tanks, having storage capacity 9200 KL, this 9200 KL storage tanks divided on 3 Nos. storage tanks having each capacity 3000 KL and 1 No. of storage tank having capacity 200 KL, this water is pumped to water treatment plant having capacity 1.0 MLD. The raw water which is received in buffer water storage tanks is pumped to aerator for better ‘oxygen contact with water. Raw water from aerator is passed through mixing channel, 15-40 ppm alum dosing based on turbidity, In mixing channel to generate clogs of suspended particles in raw water. ‘Raw water from mixing channel is collected in flocculator, Flocculation treatment technique is help to remove particles, flocculation is stirring or agitation to encourage the particles then raw ‘water is further passed through tube settler for settle suspended particles. ‘Then raw water passed through filter media bed (sand filter) to settle spill over ‘suspended particle from tube settler, raw water from filter media bed is passed through chlorine contact to fire water tanks having capacity 1600 KI. (2 Nos of tanks having each capacity 800 KL). In chlorine contact tank dosing a sodium hypochlorite (NaOcl) solution 3 to 5 PPM to reduce the bio burden. The over flow water from fire water storage tanks is collected in to raw water storage tanks having capacity 1200 KL (2 Nos of tanks having cach capatity 600 KL). b) Potable Water The raw water is filtered through multigrade filter (MGF) and further treated with chlorine dioxide (C1O,). This chlorinated water is stored in HDPE storage tank and is passed to ultra filtered membrane and further filtered through activated carbon filter. After treatment through activated carbon filter, water is further filtrated through serics of cartridge filters of 50 micron, 10micron and 5 micron. The water passed through cartridge filters is called as Potable water. Potable water is used for drinking and general wash purpose, which complies with Potable water specification of BIS (IS 10500:2012), WHO, EU directive council and other. ©) Soft water for Utility The common MGF treated water is passed through utility softener and stored in HDPE tank which is used as a makeup in utilities like Cooling tower, Boiler, Chillers etc. PREPARED BY ____CHECKEDBY | NAME ‘Anupam Kumar Mishra ____Ujwal Bagad DESIGNATION Executive _ ‘Assistant Manager SIGN. & DATE natal re) Ceaqor?torrent TORRENT PHARMACEUTICALS LTD, DAHES ___ Restricted Circulation Wi Funmen— | SITE MASTER FILE, Page No.: 15 of 30 ] 1 ORAL SOLID DOSAGE FORMULATION FACILITY | Effective Date: O703119 | 4) Ultra filtered (UF) water Chlorine dioxide (CIO,) treated water is passed through process softener, the softener is designed for hardness reduction less than 5 ppm, if hardness goes more than 5 ppm regeneration of ‘softener is carried out as per respective procedure and is further filtered through 50,1 bag filler to remove suspended impurities. This water is further filtered through Ultra Filtration unit and stored in HDPE storage tank. UF water is dosed with 30ppm Sodium Meta Bi-Sulphite (SMBS) to remove free chlorine, and Sodium Hydroxide (NaOH) Solution as pH correcting agent. This treated water termed as UF water. This UF water is pumped to distribute all respective blocks to use for equipment washing, This UF water meets potable water specification. €) Reverse Osmosis Water Ultra filtered water is filtered through 5.0 micron cartridge filter and fed to first pass Chemical Sanitization Reverse Osmosis (CSRO) unit located in pré treatment plant. Reverse osmosis. water is stored in HDPE Storage tank and is pumped to distribute to all respective block SBM/FB1/QA-QC separately as a feed water for purified water generation. f) Purified Water Reverse osmosis water is used as feed water to generate purified water. Reverse osmosis water is passed through 5 micron cartridge filter and is stored in stainless stee! water tank. This filtered Reverse osmosis water is further passed through 5 micron cartridge filter. This filtered water is dosed with 5 ppm Sodium hydroxide (NaOH) solution for pH correction. This treated water is passed through 5 1 cartridge filter, and stored in multi-purpose storage tank. In the final treatment section the pre-treated RO water is passed through Hot Sanitizable Reverse Osmosis (HSRO) unit and Electro Deionization (EDI) unit to generate purified water. ‘The purified water is in compliance with current specifications of USP, Ph.Eur, BP, IP. The Contact part of the purified water system made of SS316/SS316L. The purified water is stored in storage tank and distributed by continuous recirculation ambient temperature loop with ‘tap-offs to different user points. The purified water distribution loop is designed to maintain ‘turbulent flow rate NLT 1.0 m/s and set quality parameters at all user points. ‘Sampling points are provided at appropriate locations to monitor the water quality on regular basis. Reliable and continuous control/monitoring of flow, pressure, conductivity is ensured. ‘The purified water generation system is sanitized at once in month by circulation the hot water having temperature not less than 80°C for 1 hour and the purified water distribution loop along with storage tank is sanitized twice in a month by circulating hot water having temperature not less than 80°C for 1 hour. ‘The purified water is used as solvent in various mamufacturing process such as Binder Solution preparation, coating suspension / Solution preparation and as cleaning medium for final rinsing of process equipment & accessories. Potable water, UF water and Purified water are analyzed routinely for physical, chemical and Microbial test as per respective specification and procedures. Appropriate records are maintained for the same. PREPARED BY a __CHECKED BY NAME ‘Anupam Kumar Mishra ‘Ujwal Bagad __DESIGNATION Executive Assistant Manager [SIGN & DATE wale Pyros?r Florent | TORRENT PHARMACEUTICALS LTD, DAHEJ PHARMA Doe. No. : SME/DE/10 a aan 3c. No. § ORAL SOLID DOSAGE FORMULATION FACILITY _| Effective Date: 0703119 Separate UF Water system (for equipment/instrument initial washing) and purified water system (for final wash and as solvent) are made available for manufacturing facilities and Quality control Iab. Schematic drawings of water systems are attached as per Appendix - 7(A). 4.1.3 Brief description of other relevant utilities Compressed Air Compressed air is generated using horizontal, water cooled, two stages, Oil free, Screw type Air Compressor with dryer. Ambient air is sucked through suction filter and compressed. Compressed air is then discharged to H.P. air end through intercooler and moisture separator, where air is cooled down in inter cooler and moisture is removed in moisture separator. Air is further compressed and its pressure is increased in HLP air end. High temperature high pressure compressed air is then passed through cooler where air gets cooled. Compressed air is filtered through various filters viz. 40y, 31 and 0.011 and distributed to user points with required pressure through stainless stee! distribution line. The atmospheric dew point of air is not more than -20°C Vacuum Cleaning System: This is used for cleaning of material containers, when the material is taken inside/outside - through Material Air lock. The system comprise of piping, dust collection bin, cartridge filter, jet cleaning through compressed air for cartridge filter. The air travels from bottom to up through series of filters and dust is collected in bottom container which is removed and emptied periodically. The air is filtered through cartridge filter (5 micron), fine filter (3 micron) and finally through HEPA (0.3 micron) before venting to environment. Nitrogen Dry compressed air supplied from dry air receiver to twin adsorption tower of N2 plant through filter. One of the two tower is under generation of N2 while remaining one is under regeneration as per the cycle operation time. Carbon molecular sieve in both tower allow passing only N2 gas in then passes through surge vessel and stored in receiver. Nitrogen air is filtered through various filters viz. 40p, 5p and 0.01. ‘The atmospheric dew point of the nitrogen gas is not more than - 40°C, Nitrogen is used for material or product specific requirement, during sampling and dispensing. Nitrogen gas is evaluated for its purity before its usage. Dust Extraction System: Dust Extraction System is used to arrest dust generited in production area during product processing. The working principal of Dust Extraction System (DEX) is same as vacuum cleaning, system. Dust collected air is passed through series of filters like F7 grade filters, Cartridge filter and H10 grade filters. The filtered air is re-circulated in the area through respective AHU connected with ducting. Pure Steam Pure steam generation system (2 nos.) having eapacity of 50 kg/hr. and 500 kg/hr. @ 3 ke/em? consist of double column evaporator and separator to generate pure steam using purified water as PREPARED BY ‘CHECKED BY NAME ‘Anupam Kumar Mishra Ujwal Bagad | DESIGNATION Executive ‘Assistant Manager gidTORRENT PHARMACEUTICALS LTD, DAHES eee creat Toe Ra teMEENIO SITE MASTER FILE Page No.: 17 of 30 No. : S ORAL SOLID DOSAGE “ FORMULATION FACILITY __| Effective Date: O103119 42 424 42.2 423 source water. The evaporator is a shell and tube type of heat exchanger. The driving foree i.e. plant steam heats the feed water in the tube side of the evaporator to generate vapour. The generated vapour enters in separator column. The separator column uses triple punch separation technique for particle entrainment and separation of impurities. Equipment List of major production equipment and QC instruments (Appendix-8) ‘The manufacturing facility is divided in different process areas i.e. Granulation, Blending, Compression, Coating, Encapsulation, and Packaging. Production equipment are designed, constructed, located and maintained to suit the operations to be carried out. Semi automated to automated, PLC based equipment are used for manufacturing and packing operations. Major product contact parts of equipment are made up of $S316 or SS316L. Non-toxic and edible grade lubricants and food grade gaskets are used wherever applicable. Quality control laboratory is facilitated with latest analytical instruments for Physicochemical, Chemical, microbial analysis and stability studies. Brief description of Cleaning and sanitizing methods Cleaning and sanitizing procedures of manufacturing areas and equipment are established. Different cleaning stages such as batch to batch cleaning, Product to product cleaning and cleaning after completion of campaign batches are identified and followed. ‘Automatic cleaning, Clean in Place (CIP) and manual cleaning procedures are adopted for various process equipment and accessories. Cleaning procedure for product processing equipment and accessories are established by cleaning validation studies. Cleaning validation plan are prepared according to cleaning validation matrix based on selection of worst cases. Processing areas are sanitized by using different disinfectants such as Germiclean Antiseptic Liquid (2.5%v/v),Germiclean Hospital Concentrate (1.0%v/¥) . Disinfectants are inter-changed once i 3 & 4 days as applicable. Disinfectant are tested for their efficacy against. the ‘microorganisms and validated for further use. All the drain points in the processing area are sanitized daily by Torcilocid concentrate (2.5%v/v). Records of Cleaning and sanitization are maintained, Fogging is being carryout out by using Torcilo! eco (10.0%v/¥) disinfectant. Description of GMP critical computerized systems ‘The business process of the organization is integrated using the System Application and Product in data processing (SAP) with application modules such as Material Management, Quality ‘Management, Production Planning, Storage and Distribution & Plant Maintenance. However, for the critical quality data related to the above modules, the data generated from SAP is checked with the hard copy of the master documents and approved by the relevant personnel. The SAP system is integrated with Indrad Plant, Torrent Research Center (TRC), Head Office, Baddi Plant, Sikkim plant, Pithampur and all CFA’s. This SAP system is validated as part of the integrated facility during performance qualification. Programmable Logic Controls (PLC) connected to the process equipment or analytical instruments are qualified to ensure maintaining of security and integrity of operations. PREPARED BY ‘CHECKED BY NAME ‘Anupam Kumar Mishra ‘Ujwal Bagad __ DESIGNATION Executive Assistant Manager SIGN. & DATE polyol 9 GE ea"— TORRENT PHARMACEUTICALS LTD, DAHES. SITE MASTER FILE ORAL SOLID DOSAGE FORMULATION FACILITY 42.4 42.5 All users of computer system are having unique user ID and password protection policy. Change contro! and Deviation are handled through Trackwise System Building Management System (BMS) is used to operate and monitor HVAC functions of the plant. Qualification and Calibration program. Production equipment and analytical instruments are qualified for installation, operation and performance qualification before its usage. The qualification team comprises of representative from User, Engineering, Project, Quality control, safety and Quality Assurarice Department. Periodic calibration program is a part of qualification activity. Each instrument associated with a particular machine is identified with a unique identification number and calibrated at predefined frequency: a Calibration frequency of instruments shall be categorized into three different categoties as critical, Non-Critical and Ancillary based on the application and usage of instrument. Rationale is prepared for usage and application of every instrument before preparing master instrument list and calibration schedule of equipment. Scientific rationale shall be prepared for instrument of ‘each equipment based on logical factors. For IPQC Instruments, calibration activity shall be performed as per frequency defined in respective calibration SOP of IPQC Instrument. Calibration shall be carried out using standard .calibration instrumients/standard reference traceable to national or international standards. Instruments for which TPL SOP of calibration procedure is not defined, same shall be calibrated by NABL certified lab/External agencies as per their respective procedures. All the calibration report and certificates have full traceability to master calibration equipment. Planned preventive maintenance program ‘All equipment and instruments are included under the Preventive maintenance program. Each Equipment/System PM is Carried as per the respective Equipment preventive module SOP, Rationale prepared for each Equipment/system based on Scientific logical factors to define check points and frequency. Preventive Maintenance schedule for Equipment/systenvIPC/Conta bin/Replacement of product, contact Gaske/PLC alarm and interlock shall be prepared in advance of cach calendar ‘year(Starting from January to December) in coordination with concemed department and the same shall be approved by. Quality assurance Department. Preventive maintenance planner shall be prepared for Plant Maintenance, Utility, HAVC and electrical Equipment. If any equipment under breakdown or the schedule date of preventive maintenance then PM of same equipment shall be cartied out after rectification of equipment and same shall be mentioned in PM Schedule AMC Schedule for IPQC instruments shall be prepared in advance of cach calendar year (Starting from April to March or 12 Months from date of issue of purchase order for AMC) in [- Sean PREPARED BY _ CHECKED BY NAME ‘Anupam Kumar Mishra Ujwal Bagad — | 7 Executive ___Assistant Manager | SIGN. & DATE \d a5 { plat OFa jorrent’ | TORRENT PHARMACEUTICALS LTD, DAHES Restricted Cir Doe. Ne ‘SITE MASTER FILE Page No.: 19 of 30 . No. IF) joc. No. : SMF/DF/10 eA SOLID DOSAGE ‘lfedive Date: 07103 118 coordination with concerned department and the same shall be approved by Quality assurance Department. AMC is carried out as per recommendation by OEM. List of machineries / instruments under “Annual Maintenance Contract” (AMC) with extemal agencies is available with the respective department for monitoring and control. 5.0 DOCUMENTATION PRACTICES Preparation, revision, distribution and storage of documentation Documentation is an essential part of Quality assurance system. Its purpose is to define and regulate system control, reduce the risk of error and uniformity in practices. Documents are prepared by user/process owner, reviewed by: user and relevant applicable stakeholders and finally approved by Quality Assurance. Approved quality documents are controlled by quality assurance department. All master’ documents are stored in documentation cell for easy and timely retrieval when required. Documentation control, issuance, distribution, retrieval and storage are maintained as per respective SOP. Master documents such as Raw material and packaging material specifications, Analytical test procediires, Product Specifications (in process, intermediate, semi finished and finished), Manufacturing .Documents (MFC, sampling protocols), Stability studies requirement and Packaging Documents (MPD, Art Works) are prepared by Torrent Research Center and issued to ‘manufacturing plant for usage. Standard Operating Procedures (SOPs) of all activities are prepared as per “SOP for SOP” by concemed department and’ approved by Quality head. Standard Operating Procedures are reviewed periodically and changes are controlled. Some of the common SOPs related to quality systems are prepared by Corporate Qualiiy Assurance dept. and’implemented across the TPL plants. Based on Master Formula cards, the corresponding site specific Master Formula cards, Quantitative formula card, Batch Manufacturing Records (BMRs) are prepared by the production and approved by QA. Photocopies of the BMR are issued under control to the production as per production planning. These documents are revised through change control procedure when formulation changes or changes to manufacturing process or change of equipment takes place. This provides a history of each batch manufactured. Batch Packaging Records (BPRs) are prepared from the reference document, Master Packing docket by the packaging section and approved by QA. Photocopies of BPR issued under control to the packing department as per production planning. These documents are revised when primary packing material or changes to packaging process or packaging configuration or change of equipment takes place and formalized through proper change control system. This provides a history of each batch packed. PREPARED BY i CHECKED BY NAME. ‘Anupam Kumar Mishra Ujwal Bagad DESIGNATION Executive ‘Assistant Manager SIGN. & DATE pw Zion SenaTORRENT PHARMACEUTICALS LTD, DAHES [pe No. : SMF/DE/10 | Effective Date: 61103| 19. These records are reviewed by Quality Assurance before final product is released for sale. Batch records are archived by QA. Batch Record includes the manufacturing documents, packaging documents and Quality Control release documents for each product Apart from above documents, following other documents and records are prepared, maintained and archived (but not limited to) Internal audit records, Change control, Deviations, Corrective and preventive actions, Validation Master Plan, Equipment cleaning and usage logs, Qualification protocol and reports, Preventive maintenance and calibration records, Process and cleaning validation protocols and reports, Training records, Risk assessment documents, Temperature, %RH and Differential Pressure monitoring records etc. Electronic records are being generated, stored and maintained to meet 21CFR Part If requirement throughout lifecycle of documents. Electronic data controls are being done through the individual user id and password policy: Data backup and retrieval of documents is being done as. per respective procedures. 6.0 PRODUCTION OPERATIONS 6.1 Type of products a) Oral Solid dosage forms such tablets and capsules are manufactured in this facility. b) Highly toxic or hazardous materials are handled in facility which is stored under control conditions and precaution are taken as recommended in material safety data sheet. Volatile solvents are stored separately out of the main building, however daily requirement of volatile solvents are. kept in production area. However, said materials handled in Quality control laboratory are kept as per the recommended storage condition in the designated storage area. Flame proof area is provided to handle the Products requiring solvent with all the necessary precautions. ©) Products such as B- lactam, Cephalosporin’s, Steroids, Hormones, Cytotoxic, etc, which require dedicated manufacturing facility are not manufactured at site. Brief deseription of production operations ‘Raw Materials are dispensed batch wise at Raw Material warehouse under the supervision of the warchouse person & it is verified by production person. Line clearance in dispensing, manufacturing and packaging departments are given by QA for all major activities with regards to cleaning of the area, equipment, lines etc. In-process checks are carried throughout production operation by QA and production department at as per BMR and BPR. Semi finished and finished goods sampling is being done at beginning, middle and end of stage. ‘Separate area is provided to store the retain sample in controlled environmental condition. Flow chart of Production operation and flow chart of movement of batch and final approval are attached as Appendix ~ 6 (B). 6.2 Process Validation | PREPARED BY CHECKED BY NAME, ~ Anupam Kumar Mishra Ujwal Bagad DESIGNATION Executive —{— Assistant Manager SIGN. & DATE oso BrewsBw =] TORRENT PHARMACEUTICALS LTD, DAHES Restricted Circulation WP Pre SITE MASTER FILE Page No.: 21 of 30 Doc, No. : SMF/DF/10 ORAL SOLID DOSAGE - FORMULATION FACULTY _ | Effective Date: 0710319 a) Bricf description of general policy for process validation Homogeneity within a batch and consistency between baiches is a goal of process validation. Process Validation offers assurance that processes are reasonably protected against sources of variability that could affect product quality output, cause supply problems and negatively affect public health. The approach adopted for the process validation activities aligns with a product lifecycle concept and with existing FDA guidance including ICH guidelines for industry, Q8 (R2), Q9 and QUO. Process validation involves a series of activities taking place over the lifecycle of the product and ‘process. The process Validation activities shall be performed in three stages 1) Process Design: ‘The product development activities are carried out at Torrent Research Center (TRC), provides | key inputs for process design such as dosage forms, quality attributes and general manufacturing pathway. The detailed Product Development Report along with critical process parameters (CPP) and Critical Quality Attributes (CQA) is provided by Torrent Research Center. 2) Process Performance Qualification: » Based on process knowledge, understanding and identified process controls at development stage ‘the reproducibility of process at commercial level is assured. Suitability of manufacturing facility, equipment and utility is ensured for the product to be manufactured. Protocol is prepared to verify facility design, Suitability of equipment and supporting utilities, operating range of equipment and material of construction. The Process Performance Qualification (PPQ) protocol covers manufacturing conditions, operating parameters, processing limits, input material details, results recording & its compilation, procedure for evaluation, test to be performed and acceptance criteria for cach significant process stops. Sampling is carried out as per sampling plan. The sampling plan includes sampling points, number of samples, quantity of samples and frequency of sampling for cach unit operation and attributes. The numbers of sample are adequate to provide sufficient statistical confidence for both within a batch and between batches. 3) Continued Process Verification: ‘Ongoing assurance is gained during routine production that the process remains in a state of control. In order to detect process variability, continued process verification is carried out. The collected process data include relevant process trends, quality of incoming material or ‘components and finished products. Continued process verification is applied at any stage of the product life cycle, ie. initial validation, to revalidation of commercialized product as a part of process changes or to support continual improvement throughout the product life cycle b) Packaging process Validation Packaging process validation is performed with separate protocol on. validation / commercial batches to establish critical, process parameter for packaging. After success full execution of packaging process validation summary report is prepared. Established process parameters are _ PREPARED BY CHECKED BY NAME ‘Anupam Kumar Mishra Ujwal Bagad DESIGNATION | ___—_—_Executive ‘Assistant Manager SIGN. & DATE wg OL gos?TORRENT PHARMACEUTICALS LTD, DAHES Restricted Circulation a aa SITE MASTER FILE | Page No.: 22 of 30 joc. No. : ORAL. BOLID DOSAGE ive Date: 071103119 63 10 incorporated in Batch Packaging Record. Any intra batch or inter batch variation which may affect consistent quality of product packaging is forwarded to packaging development team for taking up necessary actions and further it is confirmed at commercial level and documented. ©) Policy for reprocessing and reworking ‘No Reprocessing and reworking of the batches are carried out at manufacturing stage. Material Management and Warehousing a) Handling of materials (including sampling, quarantine, release and storage) Control on Raw Materials and Packing Materials ‘There is system for identification of supplier's lot number with the company’s lot number. Store ‘generates the Analytical Report Number (AR No.) for all incoming material sequentially through SAP system. Separate areas have been allocated for storage of raw materials and packaging materials as per manufacturer recommended storage conditions. Raw materials are stored in separate zones as ‘Under Test’ (Yellow labelled), ‘Approved’ (Green labelled) and ‘Rejected’ (Red labelled). Well-defined procedure for sampling of the raw materials and packaging materials exist. Sampling and dispensing of the raw materials are done under reverse laminar airflow bench. Thus, utmost care is taken to avoid cross contamination. Sampling and dispensing rooms are provided with separate air handling units to avoid cross contamination, Re testing of materials are carried out as per defined frequencies to ensure the material is not deteriorated and safe for pharmaceutical product manufacturing. Controls on Manefacturing The intermediates and the bulk are quarantined in a separate area till the Quality Control release is obtained. During storage of the intermediates and bulk, care is taken to avoid mix up and cross contamination by providing physical separations. Batch wise and product wise segregation is maintained. The containers are kept closed and with proper status label. ‘Approved’ or “Under test’ status is maintained as the case may be, by labeling containers accordingly. >) Handling of rejected materials and products Rejected raw and packing materials are stored separately with identification in designated erca. ‘Raw materials and unprinted packaging materials are returned to the supplier. Rejected printed packaging materials are destroyed at site and records are maintained. All Rejected products are stored under lock and key with proper status label. Rejected product is disposed off after thorough investigation, under Quality Assurance supervision and record is maintained. Flow chart of material movement in attached as Appendix-6 (B). QUALITY CONTROL ACTIVITIES Description of QC activities (physical, chemical and microbiological testing) ‘Quality Control department is independent of Production and other departments, with an authority to "approve" or “reject” starting materials, packaging materials, intermediate, semi- finished and finished products. Quality control department “have facility for chemical, ~ PREPARED BY ___ CHECKED BY NAME Anupam Kumar Mishra. Ujwal Se DESIGNATION Executive SIGN. & DATE | | eos\ 2 eor TORRENT PHARMACEUTICALS LTD, DAHES Beariaca Ceeaited (poe. Ne: SeoDRAB ee re ae "eae | Een a POA SOU DOSAGE. | Ritective Date: onfoatis | physicochemical, instrumental & Microbiological testing of raw materials, packaging material, in-process, intermediate materials, semi-finished and finished products. Adequate facilities, trained & competent personnel’ and approved procedures for sampling and testing of starting materials, packaging materials, in-process, intermediate materials and finished products are established to ensure that all quality control procedures are effectively and reliably carried out, Records of inspection lot and testing of materials are maintained. Test certificates are generated for the products tested with reference to approved specification and maintained as per GMP requirements. Sufficient samples of starting materials are retained to permit future examination of a product, if required. Instruments used for analysis are calibrated and qualified for its intended use. Calibration calendar and exists for quality control laboratory, giving provision for re-qualification as and when required, In-process testing is performed to ensure all manufacturing processes proceed in accordance with predefined specification. Finished products are tested using validated analytical methods, as applicable to ensure-that all products comply with predefined specifications, Procedures are available to monitor and to derive the trend analysis of water quality and the environmental control for different areas. ‘All personnel working in the laboratory possess appropriate educational qualification and professional experiences relevant to quality control functions. Further they are trained and qualified for specific area of testing along with GLP training on recruitment and periodically. Well-defined procedure for OOS and OOT (Out of Specification and Out of Trend) exists for detail investigation of product failures. Pharmacopoeias, reference standards, working standards, reference spectra, other reference materials and technical books are available in quality control unit. Stability studies of all products are carried out as per respective SOPs and applicable regulatory or 8.0 DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND RECALL 8.1 Distribution arrangements and recording system A separate facility is provided for storage of Finished Products. The products are kept on racks/pallets under recommended storage condition, Each product/batch is released for distribution through SAP System by Supply Chain department. Distribution of products to wholesale licence holders, nationally and internationally, is handled by well equipped Supply Chain department. Products are shipped and transported using: appropriate transport media under required storage conditions with monitoring (if required). E aeciueoe | caueent PALPARED BYacl T CHECKED BY NAME ‘Anupam Kumar Mishra ‘Ujwal Bagad DESIGNATION Executive Assistant Manager SIGN. & DATE qamelzyeti9 & Mand8.2 90 SITE MASTERFILE | Page No.: 24 of 30__ torrent TORRENT PHARMACEUTICALS LTD, DAHES Restricted Circulation WP Pranme 1 MF/DE/10 : FORMULATION FACILITY Ei ve Date: onfoalta Distribution records for each product/batch are maintained through SAP system to provide complete traceability. ‘The shippers or drums are pelletized or packed as per the customer requirement, Complaints, Product Defects and Recalls Well defined SOPs exist for handling of product defects, complaints and product recall. All complaints are forwarded to Quality Assurance department and are thoroughly investigated by concern head of department, relevant involved departments and Quality Assurance Head Quality/Designee receives and review all the complaint investigation’ reports. Appropriate Corrective and Preventive actions are planned and implemented to avoid reoccurrence. Detailed response is prepared and is endorsed by concerned head of department and quality shead/designee. Same is sent to head/designee of US-regulatory. In case of medical nature, the same is referred to medical division (Pharmacovigilance Department at TRC) for appropriate investigation. Response is prepared and sent to head or designee of US-regulatory. TRC having separate department to handle the adverse drug effect and Pharmavovigilance. Quality head is responsible for deciding and coordinating product recall arid to notify the customer/competent/Regulatory authority in the event of a serious or potentially life threatening situation or quality related issues. Haig eines ae eased a etepeel ceo ey bat Gaeaya aia ae disposition of materials based on investigation results. SELF INSPECTION PROGRAM Procedure for the Self Inspection/ Internal Audit activity ‘The objective of self-inspection is to evaluate compliance with cGMP requirements in all aspects forall departments. Self-Inspection of each functional department is performed at least once in a year to ensure cGMP compliance as per SOP No. CQA-090. Frequency can be increased with authorization and approval of QA head/designee, If required in area where repeated product failure was observed, ‘market complaint received which resulted into product recall and /or repetitive critical deviation ‘was reported. ‘The self-inspection team comprises representative of other cross functional department (other than Auditee) and Quality Assurance. The Quality head is overall responsible for ensuring that each department is audited. ‘The reports of the audit team include abnormalities and non-compliances observed, suggestions made to rectify and actions to be initiated by concerned departments. CAPA reports and timelines are drawn up to address all non-compliances observed. ‘The management reviews the report and actions are taken to comply the noni conformities. ‘PREPARED BY_ ‘CHECKED BY NAME. Ujwal Bagad DESIGNATION SIGN. & DATEi | TORRENT PHARMACEUTICALS LTD, DAHES 8 Aorrent | Restricted Circulation Sil Fitiai SITE MASTER FILE 'No,: 25 of 30 ORAL SOLID DOSAGE. FORMULATION FactLaTy __| Effective Date: 0°\03] 19 ‘API__ |: Active Pharmaceuticals Ingredients GIG, |: Chlorine dioxide zt ‘TPL | : Torrent Pharmaceuticals Ltd QA |: Quality Assurance ‘GMP | current Good Manufacturing Practices || QC |: Quality Control : Health Safety & Environment ‘|M |: Meter "|: Standard Operating Procedure GM ~ |: General Manager 7 Small Batch Manufacturing ‘AGM |: Asst. General Manager : High Efficiency Particulate Air VP _|: Vice President | Not Less Than TRC | : Torrent Research Centre Relative Humidity CQA_| : Critical Quality Attributes + Air Handling Unit CFA |? Carry and Forwarding Agent : Programmable Logic Control 1D |: Identification : Stainless Steel ‘Mis _| : Meter per second GIDC | Gujarat Industrial Development SAP | System: Application and Produc Corporation QRM_| : Quality Risk Management Kms GLP__| : Good Laboratory Practices UF |: Ultra Filter CSRO |: Chemical santizable reverse oamosis | | HDPE |= High Density Polyethylene HSRO | : Hot Sanifizable Reverse Osmosis HP. ICH ‘CPP _| Critical Process Parameter CAPA | Corrective and Preventive Action PPQ__| Process Performance Qualification MLD _| Metric liter per day FB1__| Formulation Block 1 ‘SBM _| Small batch Manufacturing OEM "| Original Equipment Manufacturer AMC _| Annual maintenance Contract PREPARED BY NAME | —___ Anupam Kumar Mishra DESIGNATION. Executive Weprcor'd SIGN. & DATE dusts 19 |TORRENT PHARMACEUTICALS LTD, DAHES se cratim OSE | Doe. No, : SMF/DE/10 ‘SITE MASTER FILE ORAL SOLID DOSAGE. FORMULATION FACILITY 11.0 HISTORY OF CHANGES Page No. 26 of 30 Effective Date: 07|031 19 Version| Details of Chan; No. ge Revised Page| Remarks} No. \(if any) 00 New Document NA NA o1 Manufactaring License Numbers are incorporated. Editorial changes! Allpages | NA and formatting done as per chapter 4 of GMP guide : EU guidelines 02 “To elaborate process validation activities in point 62 -Updation of contract Laboratories list according to cusrent requirement} (Appendix-4) - Updation of Manpower details (Appendix 5B) -Updation in list of Major Production Equipments and Laboratory} instruments(Appendix-8) 03 ~ Updation in General Information. - Updation in Name and details of the key personnel. ~ Updation in premises details about new manufacturing area as Granulation-2 and Coating-2 area. ~ Updation in room environment condition for classified area, unclassified area and raw material quarantine and storage area. - Updation in water System. ~ Incorporation of line clearance activity at dispensing stage. ~ Updation in Appendix-2 - List of Products to Be Manufactured. ~ Updation in Appendix-3 — List of valid GMP Certificates - Updation in Appendix-5(A) — Organisation Chart, Addition and deletion of personnel, change in designation. - Updation in Appendix-5(B)—No of Employees engaged in different section of facility ~ Updation in Appendix-5(C) - Qualification, experiences and responsibilities of key personnel, Addition and deietion of personnel, - Updation in Appendix-8 List of major production equipment and laboratory instruments, All pages PREPARED BY CHECKED BY ‘NAME. ‘Anupam Kumar Mishra ‘Ujwal Bagad DESIGNATION Executive ‘Assistant Manager SIGN. & DATE ww yoshi . aH, ANSTORRENT PHARMACEUTICALS LTD, DAHES SITE MASTER FILE ORAL SOLID DOSAGE FORMULATION FACILITY Doe. No. : SMF/DF/10 Effective Date: 0703119 ‘Revised Page [Remarks] \Gfany) Version| Details of Change _ No. No. ~ Site address details updated for incorporation of telephone numbers and fax number. 05 ~ Name of and details of the key personnel updated ~ Sentence about stability studies updated to cover Country/ Market / Customer specific requirements ~ Scope of Torrent Research Centre clarified for requirement covering ‘technical competency and need of sophisticated instruments. ~ 08 ~ Sentence on Entry to manufacturing, storage and quality blocks updated to give clarity about restriction through procedural controls, 10 o4 - HVAC System brief description updated to specify provision of NA humidification system along with dehumidification system. ~ Processing Area temperature is maintained between 15°C to 25° was u missed, So incorporated ~ Drinking water terminology renamed as potable water and Pre-wash B water terminology renamed as Ultra filtered (UF) Water. ~ Sentence on compressed air distribution to user point updated to 4 include through Stainless Stee! pipelines. ~ ‘Storage of volatile solvents for daily requirement is done in 18 processing area’ is incorporated. = Elaborated the list of appendices 26 = Updation in tumover = Added one manufacturing facility of Indore (Madhya Pradesh) 05 = Removed word recently from general information = Updation in contact details of key personnel = Updation in Quality risk management description = Updation in Training management status = Removed information of Granulation-2 and Coating-2 area = Theorporated details of New buffer water tank B 05 |= Updation in Appendix-3 — List of valid GMP Certificates oT NA = Updation in Appendix-5(A) — Organisation Chart, Addition and oI deletion of personnel = Updation in Appendix-5(B) —_No of Employees engaged in different or section of facility | =] 5] S| g| = Updation in Appendix-5(C) - Qualification, experiences and @ |__ responsibilities of key personnel, Addition and deletion of personnel, = Updation in Appendix-6(B) General flow charts of manufacturing processes of each product type = Updation in Appendix-8 List of major production equipment and 0 laboratory instruments. 03,05 PREPARED BY __ CHECKED BY NAME Anupam Kumar Mishra. ‘Ujwal Bagad DESIGNATION Executive ‘Assistant Manager SIGN. & DATE gw Pind Ot ones?a TORRENT PHARMACEUTICALS LTD, DAHES I Doe, No. : SMF/DE/10 SITE MASTER FILE ‘ORAL SOLID DOSAGE FORMULATION FACILITY Page No.: 28 of 30 - Effective Date: 0703/19 |} Version| No. Details of Change ‘Revised Page No. [Remarks}} (if any) = Updation in Name and details of the key personnel 06 = Updation for temperature condition in warehouse, Quarantine and QC section as 2°C to 8°C 1B = Updation in interchange frequency of sanitization solution _ 7 NA ~ Tn Annexure 6(B) name changed from Bonded store room to Finished Goods Store 03,04 = Updation in description of water system in point no. 4.1.2 14 = Updation in Appendix-5(A) — Organisation Chart, Addition and deletion of | OL = Updation in Appendix-5(B)—No. of employees engaged in different section of facility o1 = Updation in Appendix-5(C) — Qualification, Experiences And Responsibilities of Key Personnel 01 to. 03 NA = Updation in Appendix- 2 — List of Dosage Forms And Type of Products Manufactured On Site = In Point No. 1, a) Updation in general information. b) Updation in tumover _©) Updation in city names for manufacturing unit on ~ In point no. 1.1 (b) Updation in contact no for Mr. Jayendra Tripathi 06 = In Point No. 1.2 Elaborated details regarding the list of GMP audit. ~- In Point No. 2.1 Updation in details about The Quality Management System of the manufacturer 07,08 ~ In Point No. 2.3 Updation in details about Management of suppliers and contractors = In point no. 3.0 4) Elaborated details regarding Training activity. ©) Elaborated details regarding Health requirement for personne! a 5 10 NA ~ Im point no. 4.1 (b) Updation in details regarding the general information rélated to |__premises and equipment. ie u = In Point No 4.1.1 Updation in Brief Description of Heating, Ventilation and Air Conditioning (HVAC) System ae es 12,13 = In Point No 4.1.3 ‘Updation in details of Compressed air and Nitrogen system = In Point No 4.2.4 Updation in details for Qualification and calibration programme 16 PREPARED BY CHECKED BY NAME. ‘Anupam Kumar Mishra _ Ujwal Bagad DESIGNATION Assistant Manager SIGN, Executive | . & DATE qwwe OL posTORRENT PHARMACEUTICALS LTD, DAHES Doe. No. : SMF/DF/10 ORAL SOLID DOSAGE . romunusrtonsnetry | Efeive Date: 0115 ‘SITE MASTER FILE Page No. 229 of 30 _ a Version| No. Details of Change Revised Page| No. [Remarks] (if any) = In Point No 42.5 ‘Updation to elaborating for Preventive maintenance programme. 18, = Point No.8.1 and 8.2 Updation to elaborating the detailed procedure Complaints, Product defect, and recall. 23 08 = Updation in Appendix-3 to incorporate inspection details or NA = Updation in Appendix 4(B) to incorporate the additional contract testing laboratory 03 ~ Updation in Appendix 5 (A),(B),(C) to update the personnel details All = Updation in Appendix 8 to update the Equipment and instrament list_| All = Updation in Name and details of the Key personnel ~ Arranged in sequential manner All = Updation in Appendix-5(A) — Organisation Chart, Addition and deletion of, o1 ~ Updation in Appendix-5(B) — No. of employees engaged in different section of facility - 01 09 ~ Updation in Appendix-5(C) — Qualification, Experiences And Responsibilities of Key Personnel NA = Updation in Appendix- 2 — List of Dosage Forms And Type of Products Manufactured On Site 02 = Updation in Appendix- 3 ‘of GMP Audits All = Updation in Appendix 4(B) to incorporate the additional contract testing laboratory 03 = Point no. 4.1.1 is updated with change of 35°C to 50°C. B Point no. 4.1.2 Raw water details updated in Brief Description of 8 4 Water System = Point no. 4.1.3 Brief description of other relevant uillities is updated with details of new 500 kg/hr pure steam, 16 = Updation in Appendix- 2 — List of Dosage Forms And Type of. Products Manufactured On Site z 10 5 Deana a areas 5(A) — Organisation Chart, Addition and deletion of z = Updation in appa ‘5(B) — No. of employees engaged in different section of facility z = Updation in Appendix-5(C) — Qualification, Experiences And of Key Personnel Responsi = Updation in Appendix 6 (A) “Layouts of Production Areas Including Material & Personnel Flows All = Updation in Appendix 7 (A) “Schematic Drawing of Water System _ All = Updation in Appendix 8 “List Of Major Production Equipment And Laboratory Instruments” All PREPARED BY CHECKED BY NAME Asam Kumar Mises ‘Ujwal Bagad __ DESIGNATION ‘Assistant Manager SIGN. . & DATE FoRyein Os awdfon " meg ‘TORRENT PHARMACEUTICALS LTD, DAHEJ Restricted Cirealation GD. rere Doc. No. : SMF/DF/10 ‘SITE MASTER FILE ‘ORAL SOLID DOSAGE FORMULATION FACILITY Page No.: 30 of 30 Z Effective Date: onl 03/19 12.0 LIST OF APPENDICES ‘Appendix-1 Copy of valid manufacturing authorization Appendix-2 ist of Dosage Forms and type of products manufactured on site | ‘Appendix-3 ‘List of GMP Inspection.” “Appendix-a(A) List of Contract Manufacturers and contact details Appendix-4(B) List of Contract Laboratories and Contact details — 1 ‘Appendix-5(A) ‘Appendix-5(B) ‘Organizational Chart ‘No of Employees engaged in different section of facility | Appendix-5(C) ‘Qualification, Experiences and Responsibilities of Key personnel Appendix-6 (A) Layouts of production areas including material & personnel flows. | | ‘Appendix-6 (B) General flow charts of manufacturing processes of each product type. Appendix-7 (A) ‘Schematic Drawing of Water System ‘Appendix-7 (BY ‘Schematic Drawing HVAC System (Classified Area) ‘Appendix-7 (C) ‘Schematic Drawing HVAC System (Unclassified Area) | ‘Appendix-8 List of Major Production Equipment and Laboratory Instrument PREPARED BY _ CHECKED BY NAME. ‘Anupam Kumar Mishra ~ Ujwal Bagad DESIGNATION Executive Assistant Manager SIGN. & DATE awiltqals Os Hon S |SITE MASTER FILE Doc. No. : SMF/DF/10 APPENDIX-1 Edition No.: 00 Page No 1 of 1 Effective Date: 071] 03119 | COPY OF VALID MANUFACTURING AUTHORIZATION Licence No + 1) G/25/2010 in Form No. 25 & 2) G/28/1453 in Form No. 28 PREPARED BY CHECKED BY NAME, ‘Anupam Kumar Mishra Ujwal Bagad DESIGNATION Executive ‘Assistant Manager SIGN. & DATE WShe nericanmecenanT > ig Office of the Commissioner, Food & Drags Control Administration, Block No: 8, 1” Floor, Dr. Jivraj Mehta Bhavan, ‘Gandhinagar — 382.010 Gujarat State, India. Date: SS “HL 2018 To, jar Torrent Pharmaceuticals Ltd., Plot no. 7/104 to 106, Dahej SEZ Part - I, ‘Tal Vagra, Dist - Bharach 393 130. SUB: i Isgue of Licence Validity Certificate. Sir, REF: Your letter dated. 27/06/2018. I send herewith the Licence Validity Certificate in one copy as desired by you. ‘Yours oem For a Food & Drugs Control Administration,No: FocAMEGICERTUNS FES YL, Office of the Commissioner, Food & Drugs Control Administration, Block No: 8, {* Floor, Dr. Jivraj Mehta Bhavan, Gandhinagar — 382 010 bangs Ohm LICENCE VALIDITY CERTIFICATE This is to certify that M/s, Torrent Pharmaceuticals Ltd., situated at Plot no, Z/104 to 106, Dahej SEZ Part - Il, Tal — Vagra, Dist - Bharach, 393 130, Gujarat State, India is holding valid drug manufacturing licence in Form No. 25 & 28, bearing licence No: G/25/281@ & G/28/1453 respectively valid up to 05/07/2018. They have applied for renewal of the said licences for the period of 06/07/2018 to 05/07/2023. These licences shall continue to be in force until orders are passed on the application under the provisions of Drugs & Cosmetics Act 1940 & Rules thereunder. This certificate is issued on the hasis of records available in this office.\ SETE MASTER FILE torrent. SMF/DE/10 | Doe. No. APPENDIX-1 Effective Date: 07/031 19 Page No.: 1 of I Licence No. : 1) G/25/2010 in Form No. 25 & 2) G/28/1453 in Form No. 28 PREPARED BY CHECKED BY NAME, ~ Anupam Kumar Mishra ‘Ujwal Bagad DESIGNATION Executive is SIGN. & DATE ye aSITE MASTER FILE Doc. No. :SMF/DF/I0 APPENDIX-2 Edition No.: 00 + LIST OF DOSAGE FoR! D TYPE OF P '$ MANUF, SITE 1) LIST OF DOSAGE FORMS «Uncoated and Coated Tablets © Hard Gelatin capsules 2) LIST OF PRODUCTS ‘Sr. — | aa 7 ra Product Name Strength(ing) Dosage form 1. __| Bscitalopram Tablets ‘5/0720 Film Coated Tablet | 2.__| Indapamide SR Tablets 15 7 Film Coated SR Tablet 3. | Lercanidipine Hydrochloride 10720 Film Coated Tablet Teblets o -4._| Mirtazepine Tablets is Film Coated Tablet 3.__ | Citalopram Tablets 10720740 — —___| Film coated Tablet | 6. _ | Pramipexole Tablets (US) 0.125 /0.25/0.510.75/1 | Uncoated Tablets | AS 7. | Montelukast Sodium Tablets 4 75* 0 Uncoated Tablets | 7 B __| *Chewable Tablets | 8,_| Teimisartan Tablets 20/40/80 ‘Uncoated tablets 9,__| Telmisartan + HCTZ Tablets 40+12.5/80412.5/80425 ‘Uncoated tablets 10, | Carbamazipine Tablets 100 mg (chewable) /200 mg_| Uncoated Tablets | 11,_| Losartan Potassium Tablets 25 150/100 Film coated Tablet 12. | Losartan Potassium + HCTZ '50+12.5/100+12.5/100#25 | Film coated Tablet Tablets 13._| Lamotrigine Tablets USP 2575071007 150/200 ‘Uncoated Tablet 14, | Isosorbide Mononitrate ER 30760/120 Film Coated ER Tablet ‘Tablets USP. 15._ | Donepezil Hydrochloride Tablets | 5/10 Film Coated Tablet 16. _| Leviteracetam Tablet 250/ 500/ 750 / 1000 Film Coated Tablet 17._| Risperidone Tablets 0.25/0.5/1/ 21 3/4 Film Coated Tablet. _ 18._ | Zolpidem Tartarate Tablets 5/10 Film Coated Tablet 19. | Pantoprazol Tablets 20/40 ___ | Enteric Coated Tablets | |20. | Rivastigmine Capsules 6 Hard Gelatine Capsule | 21, | Fenofibrate Capsules a 67/134/200 ‘Hard Gelatine Capsule 22._| Ivabradine hydrochloride tablets 5/75 Film Coated tablets 23. | Dimethyl Fumarate Delayed 120/240 ‘Hard Gelatine Capsule Release Capsules area 24. | Pioglitazone tablet USP 15 __| Uncoated Tablets 25._| Piribedil Tablets a 50. ‘Sugar Coated Tablets 26. | Macitentan Tablets 10 Film Coated Tablet PREPARED BY CHECKED BY { NAME ‘Anupam Kumar Mishra ‘Ujwal Bagad |___ DESIGNATION Executive Assistant Manager SIGN. & DATE wR 19 OX, osw9= torrent SITE MASTER FILE, is 8 Rae Doc. No. : SMF/DF/10 Page No.: 2 of 2 APPENDIX-2 |e a | t | Effective Date: 07 [03]19 1 = Product Name | Strength(mg) Dosage form i 27._ | Febuxostat Tablets [407807120 Film Coated Tablet 28._| Vortioxetine tablets ~ [5710720 : Uncoated Tablet 29. | Quetiapine Fumarate ER/PR 50/150/2007300/400 | Film Coated Tablet Release Tablets i 30. _| Esclicarbazepine Acetate Tablets | 200/400 / 600/ 800 Uncoated Tablet 31. | Esomeprazole Magnesium DR | 20/40 Hard Gelatine Capsule Capsules 32._| Dapagliflozin Tablets 3710 Film Coated Tablet 33, | Dapagliflozin and Metformin 5+500/5+1000 710+5007 | Film Coated Tablet Hydrochloride ER Tablets 101000 meee 34.__| Apremilast Tablets 10/20/30 Film Coated Tablet 35. | Minocycline Hydrochloride 30/75/10 ‘Hard Gelatine Capsule Capsules 36,__| Clopidogra Tablets B Film Coated Tablet 37._ | Ticagrelor Tablets 60/50 Film Coated Tablet 38,__| Sitagliptine Tablets 257507100 __| Film Coated Tablet | i 39. | Sitagliptine and metformin '50+500 / 50+1000 Film Coated Tablet i Hydrochloride Tablets { Fenofibrate Tablets 347160 ~ | Film Coated Tablet i Trazodone Hydrochloride Tablets _ | 50/100 /150/300 Uncoated Tablet, t ‘Aripiprazole Tablets 10/15 720/30 Uncoated Tablet i Duloxetine DR Capsule 20/30/60 Hard Gelatine Capsule i Celecoxib Capsule 50/100 / 200 400 ‘Uncoated Tablet ' ‘Topiramate Tablets USP 25/50/100/200 Entric coated Tablet i Rosuvastatin tab. USP ‘S/10/20/40 Film Coated Tablet t Acetazolamide tab. 125/250 ‘Uncoated Tablet | Clomipramine HCL cap [25/50/75 Zi Hard Gelatine Capsule i Saoubitril & Valoartan tab. 244261494511 974103 Film Coated Tablet 4gm Powder i [507757100 __| Film coated tablet i S/S Uncoated tablet | 75/150 Film coated tablet | f | t | i PREPARED BY CHECKED BY i NAME ‘Anupam Kumar Mishra ‘Ujwal Bagad | DESIGNATION ___ Executive ‘Assistant Manager I SIGN. &DATE | Qu sap Opened { oatorrent [ SITE MASTER FILE 8 Paaeme | Doc. No. - : SMF/DE/10 Page No.: 1 of 1 | Sane APPENDIX-3 Snledite 7 | eae icas | Effective Date: ©1103] 19 + LIST OF GMP AUDITS Sr.No [Name of authorization / Regulatory Body Date of inspection 1 State GMP 10/06/13 to 10/06/13 2 |EUGMP a E 04/12/13 to 07/23 3. | State GMP : ‘28/02/14 to 28/02/14 4 USEDA — ‘06/04/15 to 10/04/15 5 State GMP GOS to 030915 | 6 [EUGMP T4/I2/AS to 21/25 7 | State GMP 23/04/16 to 23/04/16 [8 ANVISA _ 04/04/16 to 08/04/16 [10 [USFDA : 26/06/17 to 30/06/17 ii | EUGMP TOAIAT to 13/11/17 12 |StateGMP 2203/18 to 23/03/18 PREPARED BY CHECKED BY NAME ‘Anupam Kumar Mishra Ujwal Bagad DESIGNATION Executive ‘Assistant Manager SIGN. & DATE Spam Bepaeattd GFE goon8 torrent Page No.: 1 of 1 = APPENDIX- 4 (A) Effective Date: 0°}03] (9 . IF CO} .CT_MANUFACTUI 1D CONTACT DET. No contract manufacturer service shall be used. i PREPARED BY CHECKED BY NAME ‘Anupam Kumar Mishra Ujwal Bagad DESIGNATION Excoutive ‘Assistant Manager SIGN: & DATE pooh Gt onoSITE MASTER FILE [Doc.No. :SMF/DF/I0 | Page No.: 1 of # | APPENDIX-4(B) | ee Effective Date: 07}03[19 | . [ST NTI ND CO! 'T DET: Sr. No. Name of Laboratory Address and Contact Number 1 | Analytical Solutions Plot B-22, TTC Ind. Area, MIDC, : Chinchavali, Navi Mumbai - 400708, india. Contact Person: 1)Dr. AJ. Vaidya (Director): Aviad icalsolutions.in 2)Mr. Tushar Ghule (Manager QA): ‘Tushar ghule@analyticalsolutions.in Mobile -+91 8879940151 Phone : +91 22 27690080 Fax __: +91 22 27690087 __ ‘Choksi Lab -Indore 623, Manoramaganj, Indore-452001,Madhya Pradesh (MP). Contact Person: 1)Mr. Shailendra Kshirsagar (GM,QA) Shailendra.kshirsagar@choksilab.com ‘Mobile : +91 9713010430 Mobile : +91 9713021717 Contact Ne Phone : +91 7314243888__Fax_: +91 731 2490593 3. | Bhabha Atomic Research Centre Environmental Survey Laboratory, Kakrapar Atomic Power Station, (A govtof India Enterprise), Tal : Mandavi , Dist.: Surat, Gujarat- 394651. Contact Person: Dr. AK Patra, Lab head, Contact No.: +91 2626 230330 ‘Vimta Laboratory, Hydrabad ‘Vimta Labs, Td. 5, Alexandria Knowledge park, Genome Velley, Shameerpet, Hyderabad 500078 Contact Person: 1) Ms.S.Prasanna Bharati (Group Leader- QA) Phone : +91 4067404040 Mail : prasanna.siddula@vimta.com 2) Mr.Agjun Singh (Business Development) + +91 4067404401 ‘CHECKED BY NAME ‘Ujwal Bagad DESIGNATION Assistant Manager "SIGN. & DATE PH gang?‘SITE MASTER FILE, ‘Doc. No. : SMF/DE/10 Edition No: 00 torrent ake eanemn Page No.2 of 4 Effective Date: O7|03119 APPENDIX-4(B) Sr. No. 5 Name of Laboratory SGS India Pvt Limited Chennai ‘Sequent Research Limited { Manglore : — Address and Contact Number. -| SGS India Pvt. Limited. 2" Floor, TICEL Bio Park, CSIR Road, Taramani, Chennai-600113, India. Contact No.: Phone : +91 4466139006, 1) Mr. K Dhrmaraju. E-mail : k.dharmaraju@sgs.com Mobile : +91 9962099003 2) Mr.S Ramasamy (Compliance Manager QA) Phone : +91 4422542600 3) Mr. Govindan G.(National Quality Manager) Mobile : +91 9884316660 4) Mr. Satish Kumar M. (Head — Laboratory Services) Mobile : +91 9840810006 ‘Sequent Research Limited 120A & B, Industrial Area, Baikampady, ‘New Manglore, 575011, India Contact Person: | 1)Mr. $ Natarajan (Sr. Manager Analytical Services) | Mobile: +91 9731977344 | | Bumail ; natarajan.sivaham@srl.sequent.in | 2)Mr, Somakumar (Sr. Manager QA & Complience) Mobile: +91 8861757144 E-mail : somakumar.n@jsrl.sequent.in _ Shiva Analyticals (India) Pvt. Ltd,, Bangalore Shiva Analyticals (India) Pvt. Ltd., Plot No. 24D (P) & 34D, KAIDB Industrial Area, Hoskote, Bangalore, Kamataka - 562114 , India, Phone : 080-28015333 Contact Person: 1) Dr. G Sudesh kumar (Chief Executive officer) E-mail : sudesh.kumar@shivaanalyticals.com Mobile : +91 9880106073 | Mr. Rajnish kumar singh (DGM, Sales & Marketing) E-mail : rajnish.s@shivaanalyticals.com | Mobile : +91 9980097322 | Mr. Kalyan Chakravarthi (Manager, Pharma Lab.) E-mail : kalyan@shivaanalyticals.com Mobile : 491 8951472012 Mr. M, Sathya Moorthy (Manager, Quality) E-spail : sathyamoorthy.m@shivaanalyticals.com Mobile : +91 9986061450 2 3) 4) PREPARED BY (CHECKED BY NAME. ‘Anupam Kumar Mishra Ujwal Bagad |_ DESIGNATION SIGN. & DATE ‘Executive ware ‘Assistant Manager & oer®@ jorrent SITE MASTER FILE - Fs Doc. No. : SMF/DF/10 Page Noz3 of 4 APPENDIX-4(B) Tes Eee \ ee Edition No.: 00 ive Date: 01103119 Sr.No.| _ Name of Laboratory Address and Contact Number 8 | Sitec Labs Pvt Ltd., ‘Navi Mumbai PEE — DEE Infotech, Plot No.: Gen —40, TTC, MIDC Behind Millennium Park, Near NELCO Bus Stop, Mahape, New Mumbai — 400 710, Maharashtra. Phone : 022-2778 6200, Fax : 022-27786241. Contact Person: 1) Mr. Jaysingh R Singh (Analysis / Research Division) E-mail : jay@siteclabs.com Mobile : +91 9820217453 2), Mr. Godwin Lazarus (Analysis / Research Division) E-mail : godwin@siteclabs.com Mobile : +91 9820479298 3)’ Mr. Shailesh H. Chudasama (Business Development Manager) E-mail : Shailesh. chudasama@siteclabs.com Mobile : +91 9821118376 9 _ | Stabicon Life Science Pvt. Itd., Bangalura Plot No. 28, ‘Bommasandra Industrial Area (Sub-layout), 4th Phase, Jigani Hobli, Anekal Taluk, Bangalore - 560 100, Kamataka, India. Contact Person: 1) Mr. L.N.Rao (Chief operation officer) E-mail : Inrao@stabicon.com Mobile : +91 7022378273 2) Ms. Malini Sharma (Co-Ordinator- QA) E-mail : pga@stabicon.com Mobile : +91 8105786167 3) Mr.Venlkatesan V. (Sr. Manager QC) E-mail: venkatesan@stabicon.com Mobile : +91 7022281064 10 | Startech Labs Pvt. Ltd., 2nd Floor, SMR Chambers Hydrabad. 1-58/7, Madinaguda, Hyderabad 500050 Telangana State, INDIA| Contact Person: 1) Dr. Upendra M. Tripathi. Email : drtripathi@startechlabs.com Mobile : +91 9391380300 2) Mr. Sudeep Sachan. E-mail : sudeep@startechlabs.com Mobile : +91 7672022113 PREPARED BY CHECKED BY NAME, ‘Anupam Kumar Mishra Ujwal Bagad DESIGNATION Executive ‘Aseistant Manager SIGN. & DATE, wr qas\ Or, ess |SITE MASTER FILE it /GvK Biosciences Pvt. Ltd. { | Hydrabad Doc. No. : SMF/DE/I0 APPENDIX-4(B) Edition No.: 00 Sr.No, Name of Laboratory Address and Contact Number Plot No. 125 (Part) & 126, IDA Mallapur, Hydrabad — 500076, India. | Contact Person: | 1) Srechari Babu Putchakayala (Vice President) E-mail : stee.putchakayala@gvkbio.com ‘Mobile : 09676153300/04067483400 2) Siva Kumar Susarla (Principle Scicutific Manager) E-mail : sivakumar.susarla@gvkbio.com Mobile : 07337349335 3) Sivaprasad Komali E-mail : sivaprasad.komali@gvkbio.com Mobile : 07995007641 | 12. | SGS India Pvt. Lid. Plot No. A 772/773, MIDC, | Navi Mumbai. TIC Industrial Estate, | Koparighairane, Navi Mumbai ~ 400701, India. | Contact Person: ; 1) Mr. Hitendra Vartak (Head Lab- SGS LSS Mumbai , | Chennai) | E-mail : hitendra.vartak@sgs.com Mobile : 8291815851 2) Ms. Sunita Hegde (Lab Manager — SGS LSS Mumbai) E-mail : sunit com | Mobile : 7738219722 3) Ms. Ashwini Bhadang (QA Manager — SGS LSS Mumbai) E-mail : ashwini.bhadang@sgs.com i Mobile : 8291815853 = PREPARED BY CHECKED BY NAME, ‘Anupam Kumar Mishra Ujwal Bagad DESIGNATION Executive ‘Assistant Manager SIGN. & DATE july o3 19 & ne?Seer nsrtt 9B NAVE oT BLVG NDS Be oe ent ENDS Bieay MESSY ___ sAROSKT, NOLLVNOISAG | patea BATA (i aA UR uO =i aINVN Ad GAH ie Ad Gatvad eunitiy ous, geys [PMR || oped] seus, spemy es: ara Ll md || aus magngop | yous wsofesa 9% lfm Yom Yi rama wa | Weus DIN. ap (gseoRUY | SemL I | MAA | you aN | SAT 4A || qaqesuomnapy | Acy apy || SNA || usgey'ayy |) AR A av) (aopeinmze) ||(sopmnuog) |(wonsmsog || Gay) XAXTVAD) || (Od 3D) \O10a- 90) av) VO | ex04- VO)O10- VO)|| (OOM YO) | CmPY) cw JSH || (eg og) |] Sopnomioery ‘Soysauiteg || wopompoag |} wopanpesg | wonamposg wov |[_mov | nov. |-Kov || ov | nov || nov” | mov. || nov ||-Wov || wove || cKov. “nov | "nov. || nov | HOV t * ¥ t E F E zy Tt t 5 ‘unang ‘eos ee ae el (opeqnmos) (opeamuog) || (onwemog) Gav) GD ALYTVD | | Lay # GonNAMOS (somsims04) ‘ONRITINIONE || ONIOVAOVA | NOLLAGOWd || NOLLOAGOYG =wo || aurvno-wo YO-W9 "Wo, | cc) E swwOM - a4 Woas Geom aT AOLIMIUG FALLAIAXT TRV WNOLLVZINVWO a BilealLo saa sans 7 [e PE enees -00 ON ORIPEL i - TJOT TON aBeg (W)s-XIGNAddV OLAS “ON 200 auaon = WT UAISVW LISSITE MASTER FILE Dec. No. : SMF/DE/10 APPENDIX-5(B) Page No.: | of 1 Edition No.: 00 Effective Date: O1[03|19 + NO. OF EMPLOYEES ENGAGED IN DIFFERENT SECTION OF FACILITY, Sr. ‘Department ‘Technical No. : Staff 1 ‘Quality Assurance (Formulation) 159 2 ‘Production (Manufacturing) + Technology Transfer (Formulation) 124 3 ‘Production (Formulation Packaging) eZt 4 ‘Quality Control (Formulation) 251 3 | Formulation Warchouse 34 6 | Project and Engineering (Formulation) o 7 | Health, Safety and Environment 20 8 ‘Other Support Services (HR/Admin/Operational Project/IT/Finance/Procurement/Others) vn 9 ‘Production Planning Control 5 10 FG Store (formulation) 5 ‘Total $20 PREPARED BY CHECKED BY NAME ‘Anupam Kumar Mishra [ ‘Ujwal Bagad _DESIGN, (ATION Executive Assistant Manager SIGN. & DATE de Fa al 19 Hrowea ‘SITE MASTER FILE a= Doc.No. : SMR/DE/0 APPENDIX-6 (A) | PaeeNow Loft Edition No.: 00 | Effective Date: y7fo3} 19 oL ‘OF PROD! LUDING MATERIAL & PERSONNEL FLOWS LIST OF LAYOUTS : [Layout Title Facility / Block Name Site pian ‘Complete Site TPL-SMP/OL ‘Man & Material Flow layout _| Small Batch Manufacturing | TPL-SBM-008-GF-04 ‘Area Classification Lay out _| Small Batch Manufacturing _ | TPL-SBM-006-GF-04 Pressure zoning Layout | Small Batch Manufacturing | TPL-SBM-007-GF-05 Civil Layout ‘Small Batch Manufacturing | TPL-SBM-010-GF-05 ‘Man & Material Flow layout | Formulation Warehouse TPL-FWH-GF-003 / 07 ‘Area Classification Lay out | Formulation Warehouse "TPL-FWH-GF-002 /07 ‘Pressure zoning Layout ‘Formulation Warehouse ‘TPL-FWH-GF-004/ 08 Civil Layout Formulation Warehouse "TPL-FWH-GF-005 /07 ‘Man & Material Flow layout _| Formulation Block-1 "TPL-FBI-GF-002 / 05 ‘Area Classification Lay out _| Formulation Block-1 "TPL-FBI-GF-004 705 Pressure zoning Layout Formulation Block-1 “TPL-FBI-GF-003 /05 Civil Layout Formulation Biock-1 TPL-FBI-GF-001 705 PREPARED BY (CHECKED BY —_ NAME i ____‘Ujwal Bagad DESIGNATION i Assistant Manager SIGN. & DATE Or qalestts| tf ye NR ee| Do orena| weer | nouxa@e¥ovauy | | ~ | oo smothwunournnos) Ee [on [oo ave ey [= [= su} “sameesrem | sg | count Svounsovmavie ewan | = 6B |7S. fo fe __ltainie aadHaGROUND FLOOR PLANGROUND FLOOR PLAN4 a ta hi cf Life GROUND FLOOR PLANGROUND FLOOR PLAN‘SITE MASTER FILE a ean Doc. No. : SMF/DE/IO APPENDIX-6 (B) Page No.: 1 of 6 Edition No.: 00 Effective Date: 7103119 © GENERAL FLOW CHARTS OF MANUFACTURIN CESSES. PRODI SAGE FOR! FLOW CHARTS OF MANUFACTURING PROCESSES: |. Incoming Material flow chart . Tablet manufacturing flow Capsule manufacturing . Movement of Batch Manufacturing Record (BMR) Movement of Batch Packaging Record (BPR) A PREPARED BY NAME. DESIGNATION SIGN. & DATE,SITE MASTER FILE | Doe-No. |: SMP/DE/10 APPENDIX-6 (B) Page No.: 2 of 6 Effective Date: 0103] 19 * INCOMING MATERIAL FLOW CHART. RAW MATERIAL PACKAGING MATERIAL —— ae zs SAMPLING | UNDER TEST ce Q.C. TESTING FOR MANUFACTURING PACKAGING RETURN TO SUPPLIER / DESTRUCTION PREPARED BY CHECKED BY NAME DESIGNATION SIGN. & DATESITE MASTER FILE Doe, No. - : SMF/DF/10 APPENDIX-6(B) NAME DESIGNATION SIGN. & DATESITE MASTER FILE Doc. No. : SMF/DF/10 Edition No.: 00 APPENDIX-6 (B) Page No.: 4 of 6 Effective Date: 01193119 * PROCESS FLOW. CHART — CAPSi (UFACTURING DESIGNATION SIGN. & DATEALVG ¥‘NDIS NOLLVNOISAG (YOO) s1sA[eay Jo eyeoyier) Jo uoaredarg yoteg Jo wonepdarog | VO 4q ponssy vou |_| uoy Dad Guouannbay | | IN JO saydoooroyg Bopeusoya] | yeCHIO) ‘Buyuun]q Uonsnposg TUN) TUOTTA SNR LOVIANVHOLVEAO INGNGAOK * GIEG)LO seq axaRA | : ] Eos oF ear gio von ng (@) 9-XIONadav 00 "ON on Pa | OUuAQAaWS? ON 00 TM WGISVW aSTa - AnNOo mel NOLLVNDISad ‘peseg peal ‘Bays TuMTY umednay” ‘aN Aa aaa Aa Ga Aad = Toomorg 1s (WOO) sisATErTy Jo 2p ampaoaig uojmayyisadg 1 ayeoyTaD Jo uonemedasg 389] fomUOD, JonPolg paystUL | il TNOLLOGS TWILL TVNV "Sy Jo ums pue “idoq. (BerBexoed Aq woo A I 4q Wa Butsuadsiq Wd Jo} i Jouonwaguaa | | Rususdsiq | | TNOLDIS SNIDVIOVE Suydeyoeg WO 4a panssy vou |, | Daa t4 wouiannboy | 1 pansy Aas Jo saydoooroyg | _wopemozuy | : ‘ujuurig uonnpodd Sijea]LO ‘req eanoona | a 00:0 woRtpa | ——_____—| 950.9 v0N a804 | OVAGAIINS “ON 9001 | ‘Ad WaISVW ALStorrent SITE MASTER FILE ul Panama Doc. No. : SME/DF/10 ae APPENDIX-7 (A) Ce Sa Effective Date: 0702119 | « SCHEMATIC DRAWINGS OF WATER SYSTEM 1, Schematic Drawing of Water System SrNo_ | Drawing Title Drawing No, with Revision No. ‘Schematic drawing for 1 | peter system (Pages 04) . | TFL-SD-WS-601-26 PREPARED BY ‘CHECKED BY NAME “Anupam Kumar Mishra_ ‘Ujwal Bagad DESIGNATION Executive Assistant Manager ON ane Sal Ao Oy etl?os ea)E/8/8le 2 ssl aes ies 1S D oo cim D ee cmese see: Sa se, Es =e EWS) eae SE Ce | ks ee cs =]ioe C fo) meats ay a os at een avai en = * |g stoi was weesouas | (was) weyshg uonnainsia Uo NNBIEUBD JE}ENM Paying|e Srsuncad acns | “S50 | eouesajei Kosi} @BueyD << sarToat etwre ouSITE MASTER FILE Doc.No, : SME/DEF/10 APPENDEX-7 (B) “Edition No.: 00 - Page No.1 of 1 Effective Date: 07]03 | (9 + SCHEMATIC DRAWINGS OF HVAC SYSTEM. 1. Schematic Drawing - HVAC System (Classified Area) CHECKED BY NAME. ‘Ujwal Bagad DESIGNATION Assistant Manager SIGN. & DATE Gry omtostisuw i oom 00 | om somo | any (OT “Fb | fe psool] map ben es [AN EE [sa |e reer ig mate WV reas | yomdang Ss pete Bar eae at OC are on ——— cau sound weno, — on | Lau srowosvevid ammo. eno | WANSd Nt O1-H) Jott WaSH HUM LUNN ONIGNVH IV (0-H) 204 Vd3H_LNOHLIM 4UNN ONITONVH utyr SS = A cr ‘ [Porro (mater er a rouroma| VMTN ft mes = SP oor Foran “on Wout mee GRUNT STVOUASSVAAVEd LNTAHOL a —— Rela eek clan Sa aa | WAIN LNOKUM | ‘UatIGINNH3G HUM AINA ONMIONVH YIV JINN ONMTIGNVH wiv (oneSITE MASTER FILE Dec. No. - : SMF/DE/10 Page No.: t of 1 APPENDIX-7 (C) Edition No.: 00 eate erlerli4 « SCHEMATIC DRAWINGS OF HVAC SYSTEM 1. Schematic Drawing - HVAC System (Unclassified Area) PREPARED BY ‘CHECKED BY NAME ‘Anupam Kumar Mishra DESIGNATION Executive SIGN. & DATESere UaIJIGINNH 00 | “on wong . an aes ° USLIGINAHSG HLM meee ne LINN ONMONVH wiv rea eat Nit nin’ ‘Sm rama “oO! at ¥Or-s “OKSITE MASTER FILE Doc. No. : SME/DF/10 APPENDIX-8 Edition No.: 00 + LIST OF MAJOR PRODUCTION EQUIPMENT AND LABORATORY INSTRUMENTS A. List of Major Equipment in Production Small Batch Manufacturing Sr.No Equipment Name ‘Quantity 1.__ | Vibratory Sifter 4 2. | Cizer mill I 3 ‘Mechanical Stirrer a 4. 3 3.___| RMG With Co-mill 75 lit I 6. RMG With Co-mill Steam jacketed-175 lit 1 os 7____ | RMG With Co-mill -175 lit ip 8. | Quadra Co Mill i 7 9. |FBP ae 2 | 10. | FBD _ Z mon uleiaas Ti. | Oscillating Granulator 1 12. | Tray Drier aan a 13. | Conta Blender I 14.__ | Tablet Compression Machine -39 Station T 15, _ | Tablet Compression Machine -37 Station i 16. | Auto coater 2 17. _ | Compaction Machine with Trolley Z 1 1 18. __| Sampling Rod iz 8 | 19. | Automatic Capsule Filling Mic AF25T a 1 20.__| Filled Capsule Elevator i 2i.__ | Capsule De-dusting & Polishing Machine i 22.__ | Emnpfy Capsule Sorter i 23.__| Sorter Elevator 1 “a 24.__| Mini Capsule Sorter MCS 100 i 25. 2 | 26. 3 27. 2 28. 1 29. 1 30. aay if 31.___| Strip packing m/c ~4 Track (SE104) i 32,__ | EPD Collator 1 33. Blister Packing Machine-30 CPM ( C102T ) I ___ | ___ PREPARED BY CHECKED BY NAME. Anupaen Kumar Mishra ‘Ujwal Bagad DESIGNATION Executive Assistant Manager SIGN. & DATE Swrltigiohs rr wales’?i ol } torrent i SHE MASTER FILE ee 8 a 4 Doc. No. : SMF/DF/I0 1 i _ APPENDIX-8 i Edition No. 00 orlostia i Sr.No Equipment Name Quantity i 34. | Camera T 35. | Continuous Pouch Sealing Machine I i [36 | Pinhole Detection System i i 37.__| Pharmacode Reader for foil 1 | i 38. | Barcode scanner 3 ' 139. Baby conveyor 1 t 40.__| Counting and Filling Machine T | 41. | Metal Detector (Bulk Packaging) eal mal t #2. [Inline capper 7 i i 43. | induction Sealer ~ i 2 i 44. | Pharmacode reader for Inserter / Carton a 1 ol i 45. | Lifting & Positioning 2 1 46. [Lifting & Tippler 2 i 47, | Halogen Moisture analyzer 2 “i 78. |Metal Detector 4 ' 9. |Deduster 3 i 30. | Friability Test Apparatus rai 2z i 31___ | Disintegration Test Apparatus 5 i 52. | Hardness Tester 4 { 53. | Tablet(Capsule Pre Feeder (Lift & Tilt Type) 1 t 34, | Check weigher 3 | i 35. | Shrink Packaging machine 2 { 56. __| Outserter Pasting I i Pharmacode / Barcode/ OCR reader T i De-blistering Machine 1 z i Cap Re-iorquer i } De- Foiler t i Leak test Apparatus 3 ' Boitle Unscrambler with ionised air rinser T i Canister /Desiccant Inserter r I | (| Cotton inserter 1 | 65. __| Labelling Machine 1 z 1 Pouch Desiccunt inserting machine p I | Carton Coding Machine 1 i 1 68.__| Leatus Navigator system (Blister) T i | PREPARED BY CHECKED BY | NAME, ‘Anupam Kumar Mishra Ujwal Bagad TE i DESIGNATION Executive Assistant Manager i SIGN. & DATE gwiaiae Os anesoe ! Page No 3 of 9 f | I Effective Date: 01/031 19 i Quantity : 2 ie _| f i I 7 i 7 Soe ean cae 1 | 1 aE | 7 L i | | | tr i | ir -___ PREPARED BY CHECKED BY i NAME, Anupam Kumar Mishra Ujwal Bagad | | DESIGNATION Executive Assistant Manager ; SIGN. & DATE Breyer) Os todSITE MASTER FILE torrent Doc. No. : SMF/DE/10 APPENDIX-8 Edition No: 00 Page No.: 4 of 9 Effective Date: 07{ 03] 19 B. List of Major Equipment in Production Formulation Block | Sr.No Equipment Name Quantity Vibratory Sifter ‘Cizer mill Homogenizer RMG 600 lit RMG 900 lit RMG 1200 lit Co Mill (Quadro mill) FBP 5 =) S)o eT aye FBD 400 Litre (200Kgs) FBD 600 Litre G00Kgs) FBD 800 Litre (400K gs) Planetary Mixture ‘Tray Dryer Roll Compactor | Conta Blender ‘Tablet Compression Machine Metal Detector Deduster ‘Vacuum Transfer system ‘Auto coater ‘Capsule Filling fine Capsule blending machine Colloidal Mill Tablet Inspection Belt Automatic Tablets Inspection Machine ‘Bin Washing Machine FBD Bag Washing Machine Blister Packing Machine Pinhole Detection System ‘Pharmacode Reader for foil Autocartonator ‘Track and trace sy] ] a) 8] 8] =] | v0] 02] 00] Af) on] 3] Sl Ss] wo] oo} =] | 23] x] | | a] oa) a} no] | feel st ol PREPARED BY CHECKED BY NAME ‘Anupam Kumar Mishra ‘Ujwal Bagad DESIGNATION ‘Executive ‘Assistant Manager SIGN. & DATE oso Cogeric)SITE MASTER FILE [Doc. No. : SMF/DE/I0 APPENDIX-8 Edition No: 00 Effective Date: 9°} |03} 19 No Equipment Name Colour camera for blister inspection | Quantity ‘Counting and Filling Machine ‘Checkweigher with Metal Detector (Bulk Packaging) Rotary capper In line capper Pharmacode reader for autocartoner Pharmacode reader for Carton coading Lifting & Positioning Lifting & Tippler Halogen Moisture analyzer Friability Test Apparatus Disintegration Test Apparatus Hardness Tester ‘Tab/Cap pre-feeder Automatic Checkweigher (Capusle ) Shrink Packaging machine Bulk Track & Trace System Carton coding machine Leaflet Top Outserter ‘De-blistering Machine — Cap Re-torquer Leak test Apparatus Bottle Unscrambler with air rinser ‘Canister Dessicant Inserter Cotton Inserter Labelling Machine Sana = | Barcode Scanner S-|a/dfalals|a/alalnlslal-lalgl ale) a}ululs/ulelalulolalal al Thermal Transfer Printer 3 ‘Thermal Inkjet Printer 9) 8) 8) 2) 2) 8/2 8) s Pharmacode / Barcode/ OCR reader Security Seal labelling Machine 68. [@.__| BOPP tapping Machine ee} 3] wo] ur PREPARED BY CHECKED BY NAME ‘Anupam Kumar Mishra Ujwal Bagad DESIGNATION __ Executive Assistant Manager SIGN. & DATE Soon HAY ordSITE MASTER FILE Doc. No. : SMF/DK/IO zi APPENDIX-8 Pama Effective Date: 0703/19 Sr.No ie Equipment Name Quantity 70. | Label rewinding Machine T 71.__| Weighing Seale 7 72. | Analytical Balance 18 73. | sampling thief er ae 74. | Compaction Machine with Trolley 2 75. | Tablet Printing Machine Sais 7%. | Collation Unit ; Fi C, List of Major Equipment in Formulation Warehouse Equipment Name Quantity 0 i [CAF a = 4 2. |RLAF 2 3. | De Dusting Tunnel i a 4 4._ | Dock Leveller Z 5. | Solvent Transfer Pump : 4 6._| Cold Storage 1 7._| Weighing Scale 39 -| PREPARED BY ~~ GHECKED BY NAME ‘Anupam Kumar Mishra Ujwal Bagad DESIGNATION Executive Assistant [| SIGN. & DATE Sw jete Oe ponsSITE MASTER FILE Doe. No. ‘Edition Ne : SMF/DF/A0 APPENDIX-8 Effective Date: 0103] 19 | D. List of Major Instruments and Equipment in Quality Control Sr.No| Instrument /Equipment Name | Instrument / Equipment Make 1._| Air Particle Counter a ACH 1 2._| Air Sampler PBI International 1 | 3.__ | Analytical Balance Mettler Toledo 7 |_4. | Antotitrator ‘Metrohm ee ‘5.__| Bacteriological Incubator Thermolab Fee 6. _ | Barcode Scanner a ‘Motorola ml 7._ | Bio Safety Cabinet Dyna filter i 8.__| Box Comp Strength Tester ‘Test Techno Consultant fp 9. | Bursting Strength Tester Test Techno Consultant i 10. | Centrifuge Reni 6 11. _| Colony Counter Tapia” | 3 12._| Conductivity & TDS Meter _ _ Thermolab 2 13. | Cooling Cabinet ‘Thermolab 5 14. | Cooling Cabinet ‘Newtronic 4 15. | Deep Freezer ‘Thermolab 1 ‘| 16. | Deep Freezer Bio linx i 7. i i 18. im 19. i 20. 4 21. 20 22. 33. 24. 25. 26. 27._ | Friability Test Apparatus Electrolab i 28._ | Fuming Hood Citizen 2 | 29. | Gas Chromatogram. Agilent 2 30.__| Gas Chromatogram Shimadzu om |_31._| Gas Generator Prama industries 3 32._| Glassware Washer Miele 2 33.__| Halogen Moisture Analyzer ‘Mettler Toledo i 34. _| Hardness Tester Pharmatron 1 PREPARED BY CHECKED BY NAME ‘Anupam Kumar Mishra ‘Ujwal Bagad DESIGNATION Executive Assistant Manager SIGN. & DATE, aie Os ovensSITE MASTER FILE _ Doc. No. : SME/DF/10 aoe APPENDIX-8 — Effective Date: ovfostia Sr.No| Instrument / Equipment Name | Instrument /Equipment Make | Quantity 35.__[Hardness Tester Exweka aerators | 36.__| Hot Air Oven Digital Thermolab 4 | 37._ | HPLC Thermo scientific 6 38. | HPLC ‘Waters 4 39. [HPLC Shimadzu 3 40, [UFLC Shimadza 6 41,_ | Humidity Control Oven “Thermolab 2 42._| Karl Fischer = Metrohm 4 | 43._| Laminar air flow __ Kienzaids = ieee | 44. | Magnetic Stirrer ane a casa 45._| Melting Point Buchi 1 46._ | Melting Point : Mettler Toledo seen Sa) 47.__| Micro Balance Mettler Toledo 2 | 48._| Micro Balance Sartorius i 49. | Microscope Leica L 50.__| Muflle furnace Labtech 2 51._ | Nitrogen Distillation Apparatus ‘Tulin equipments I 7 52._| Oven for Dehydrogenation Thermolab T 53._| Particle sizer Malvern 1 54.__| Pass Box ‘Dyna 2 55. | pH Meter “Metrohm a 56.__| pH Meter ‘Thermo Scientific 5 57._[Pharmacode Verifier Axicon i 38._ | Polarimeter Rudolph i 59. _| Puncture Resistance Tester Presto Stantest Pvt. Lid ieee 60. _| Refractometer = Rudolph Seiten 61. |RRLC - Agilent 1 62.__| Scuff Tester ‘Test Techno Consultant 7 63.__| Sieve shaker Electrolab I 64. | Tap Density Electrolab 1 65.__| TLC Image Camera Camag 1 66. [TOC Shimadzu pera 67._| Top Loading Balance Mettler Toledo 3 68._ | Top Loading Balance Sartorius 2 69._ | Torque Tester ‘Mecmesin 1 | 70._| UV Cabinet Scientific Trading co. 3 PREPARED BY CHECKED BY NAME, ‘Anupam Kumar Mishra Ujwal Bagad DESIGNATION Executive ‘Assistant Manager SIGN. & DATE, eno | OE gatos =torrent Siemama Doc. No. : SMF/DE/10 eae PageNo:90f9 APPENDIX-8 | erie Senet ed Effective Date: 071| ©3|19 Sr. No[ instrument /Equipment Name | Instrument / Equipment Make | Quantity | 71._| Ultrasonic Bath ~__ Branson 3 72._| Ultrasonic Bath with Chiller Branson me 3.__| Ultrasonic Bath with Chiller ‘Samarth Scientific 4 | 74. | UV Spectrophotometer ee ‘Shimadzn aes 75. | Vacuum Oven ‘Thermolab oa i | a ~~ Equitron T ‘Millipore 7 Test Techno Consultant ine 5 Brookfield tT ] 80._ | Walk-In Cooling Cabinet = Thermolab | 81. | Walk-In Chamber Thermolab 3 82._| Water Bath Labtech 3 83.__| Water Bath Patel Scientific Instrument i 84. [Water Bath Equitron ee | 85. | Water Purification System Millipore 1 86._| Water Purification System EVOQUA 3 87._| Bacterial Identification System Biomeriewx 1 PREPARED BY CHECKED BY ] ___NAME| Anupam Kumar Mishra _ Ujwal Bagad eal DESIGNATION ‘Executive Assistant Manager | SIGN. & DATE the Pr Gy ernst |