si62018 ‘Biogro: Organic Management Pian My Business | Organic Management Plans | Am- Europharma Corporation (Calamba, Laguna) / Retum to Form OMP: Site Description - Operation Details Please complete this section for all new properties. To add an OMP fora non-primary operation (for example packhouse, processing or exporting) please also complete the non-primary OMP. Note that if you are adding a new property or operation to your existing certification, extra fees may apply. 1.1, Operation Details T1 Location My physical and postal addresses are the same Address (physical): Address (postal): Brgy. Saimsim ine one alamba City Laguna iu Philippines ¥] [Philippines 7 1.4.2. List Operation Contacts List contact(s) responsible for this operation: Romano N. Villanueva — President 0917 575 9246 Rosella Maria Camua — General Manager 0917 575 9263 1.4.3. General hips cients blogro co nzlomelprint_view/2333 13.sir62018 Biogto: Organic Management Plan Please provide a brief history and the aims and objectives of your operation. State your mission statement if you have one ac aineghtion in 1977, Am-Europharma Corporation's vision isto adhere o Intemational Quality Standards, Contant hi ison, the company gives focus on expanding is technical capabilities in manufactcing Weonck Process ms facies enhancement, project innovation projects, quality assurance compliance manufitarine Process improvements and personnel technical trainings Bribe ear 2014, Am-Europharma Corporation has changed its business model from being « manufacturer of Brandéd and generic products for its own requirements fo a full-fledged toll manufactorer: Tiereaueharma Corporation is continuously working in accordance with the standards tobe able to participate rtemationally in the world market making it compete, head-on with the other local and international lt Manufacturing companies today Vision serge preferred toll manufacturing company in the country adhering to international quality Standards withthe commitment of sustainable growth and development for the Filipino Mission = To be known i (Last Update: 17/04/2018) What is the legal status of your operation? Please list owner(s), partner(s), director(s), trustees), Legal Status ~ Corporation ‘Ouners: Rodrigo D, Villanueva, Alicia N. Villanueva, Roderick N. Villanueva, Romano N, Villanueva, Rosella Marie V. Camus, RiteMed Philippines ine, Amador N, Liona, Lorna D: Dagon, Jose Maria A. Ochave, Dave Frederick G. Escalona a (Last Update: 17/04/2018) What other accreditations and certifications does your operation hold? = GMP Certificate for Food and Drug from Philippine FDA 7 HALAL Certificate from HALAL Develonment Institute of the Philippines ~ HALAL Certificate from The Islamic Dawah Council ofthe Philippines, Inc, (Last Update: 17/04/2018) Please list the current Manager(s) of your certified operation and their relevant qualifications and experience. PRODUCTION MANAGER: Celerina Y, Samonte Degree in. BS Chemistry Experience in Pharmaceutical Industry since 1994 Experience in Quality Control Department from 1994-2014 Experience as Production Manager from 2014- present; With extensive trainings on quality/GMP, GLP,PICIS internal Audit, Operational Excellence, Product Reeall Committee Member Halal Assurance Team Member Quality Risk Management Team Member Internal Quality Auditor 10. 68 Champion Process improvements. QC MANAGER: 1. Licensed Pharmacist; Experience in Pharmaceutical Industry since 19943. Experience in Quality Control Department since 1994 4. Experience as QC Manager from 2014- present gill extensive trainings on qualty/GMP, GLP,PICIS Internal Audit, Operational Excellence, Process improvements, 6. Product Recall Committee Member 7. Halal Assurance Team Member Quality Risk Management Team Member 1. Intemal Quality Auditor 0. 6S Champion QA- PROCESS MANAGER: Edna O. Saur Licensed Pharmacist ‘Company Pharmacist (Distributor); Experience in Pharmaceutical Industry since 1983, Experience as Production Manager from 1983-2001; Experience as Research and Development Manager from 2001-2014; Experience as QA- Process Manager from 2014 present: Pith Extensive trainings on quality/GMP, GLP.PICIS Intemal Audit, Operational Excellence, Process improvements Product Recall Committee Member 1. Halal Assurance Team Coordinator 10. Quality Risk Management Team Member U1. Internal Quality Auditor 12, 6S Champion, QA- DDC MANAGER; Olivia Y. Lieuanat 1. Licensed Pharmacist; 2, Company Pharmacist (Drug Manufacturing); 3. Experience in Pharmaceutical Industry since 1987; 4. Experience as Produetion Manager from 2001-2005; ‘5. Experience as QA Manager from 2005-2014; 6. Experience as QA- DDC Manager from 2014- present; & ph extensive trainings on qualty/GMP, GLP,PICYS Internal Audit, Operational Excellence, Process improvements 6. Product Recall Committee Coordinator 7. Halal Assurance Team Coordinator 8, Quality Risk Management Team Coordinator 9. Internal Quality Auditor 10, 68 Champion EMD MANAGER: Virgilio Gatdula 1. Licensed Mechanical Engineer; 2. Experience in Pharmaceutical Industry since 1998: 3. With extensive experienced in plant utilities operation and maintenance ; ‘4 With extensive experienced on HVAC and chillers, utility generations and distribution, RO/DI purified/distilled water ‘treatment facilites, compressed air system, clean rooms, 5. With experience on failure analysis, spare inventories, engineering fabrications, enginceing calculations, designs, ‘autoCAD drawing and interpretation of Navisworld (3D) drawings: With experience on qualification validation of systems, facilities, process, equipments With extensive trainings on quality/GMP, GLP,PIC/S, ISO , Internal Ault, Operational Excellence, Process improvements, 8. Product Recall Committee Member 9. Halal Assurance Team Member 10. Quality Risk Management Team Member UL. Environmental, Health and Safety Vice Chairman 12. 68 Champion 6. 1. (Last Update: 1704/2018)Describe the management and reporting structure of your operation. You may attach a flow chart if you prefer under 1.1.3. above. ATTACHMENT 1 a (Last Update: 17/04/2018), Please attach any files relevant to this section: Are you responsible for harvesting of any of the ingredients? OQ Yes @ No (Last Uodate: 17/04/2018) hips ettentsbiogro co.nzlomp/print_viewi2333 2asir6r2018 ‘ogre: Organic Management Pian t+-4- Product Cates Specific Rea Please select all categories that apply to your operation: Q Ftuit and Vegetables ~ Fresh 0 Fibers Q Fiuit and Vegetables ~ Processed 1 Bakery pp Dairy Products g Dtied Goods Meat Processing (Abattoirs and g Flour Milling Meatworks) Seeds Meat Processing (Butcheries) a D Other O Beverages (including aleoholic (Last Update: 17/04/2018) beverages) Sea Food 11.5, Scope Do you intend to add any products to your scope this year? © Yes © No Please submit these recipes/product information to BioGro for approval OMP: Site Description - Employment And Staff Training Please complete this section for all new properties, To add an OMP for a non-primary operation (for example packhouse, processing or exporting) please also complete the non-primary OMP. Note that if you are adding a new property or operation to your existing certification, extra fees may apply. 1.2. Employment And Staff Training What is your employment policy? ‘Our employment policy ensures that: + The company shall endeavor o create a workplace that is fee from discrimination and bias, The company shall ensure that no employee or job applicant receives less favorable facilities or treatment on grounds of sex, marital status, disability, race, color, nationality ethnic origin religion, dependene: aie. ~ Employees for promotion and applicants for appointment shal be assessed on the bass oftheir suitability, capability and qualifications. ~ It the company’s policy to provide continuous employment for all employees. All regular employees can be assured of their job security provided that they have consistently adhere tothe Rules and Regulations ofthe Company. ~ Leave benefits are provided tothe employees in cases that employees need to absent themselves from work, as defined by the Employee's Manual ~ Training programs are provided by the company to enhance employee's development and skills, ft (Last Update: 17/04/2018)Describe staffing (number of fulltime staff, casual staff, etc) ‘Am-Europharma Corporation Manpower Summary: Regular Employees — 132 Cooperative - 35, a (Last Update: 17/04/2018) s62018 Biogro: Organic Management Plan What staff induction and training is conducted and how are training records maintained? draeine is provided to new employees anda training program is developed to update knowledge of employees ‘of new quality standards and skills needed for their assigned job functions ‘Training design: HRD ~ Company Policy, benefits, Rules and Regulations and Security Quality Assurance ~ Basie GMP,GDP, GSP and GLP Requirements Quality Control ~ GLP Requirements Huznecting Tite Drill, Health, Environmental and Safety Requirements and Proper Handling of Equipment Department Head- Work Instructions, SOP’s, and Cleaning Procedures eRe shal be given through the means of n writen exam or practicaVoral exam. Results are forwarded to the HR and is used for employee evaluation. 4 (Last Update: 17/04/2016) Please attach any documents relevant to employment and staff training: 4.22, intemal Audits Do you conduct internal audits of your production processes and procedures? ®@ Yes © No What is your complaints procedure? Describe or attach file below. ATTACHMENT 2 a (Last Update: 17/04/2016) Please confirm you will keep a register of all complaints received, take the appropriate action to resolve those complaints and record those actions. (Last Update: 1704/2018) 1.2.3, Non-Compliant Procedure a @ Please confirm you will notify BioGro if you become aware that any products Certified by BioGro become non-complaint to any markets you are certified to. (Last Update: 17704°2018)+orm BioGro verbally and in Tee ea eget © Please confirm you will notify BioGro if you become aware that any products certified by BioGro are recalled at any stage in their distribution. (Lost Upaste: 17/04/2018) sn62018 Blogro: Organic Management Pian OMP: Site Description - Environmental Please complete this section for all new properties. To add an OMP for a non-primary Operation (for example pack house, processing or exporting) please also complete the non-primary OMP. Note that if you are adding a new property or operation to your existing certification, extra fees may apply. 1.3. Environmental 1.3.1, Environmental Management State your policies on environmental management, recycling and energy use, and list ways in which you implement these policies. If any, please, refer to the relevant manuals. Amt-Europharma Corporation recognizes its commitment to protect and enhance the quality of environment in which it conducts business, Responsibilities: J. Commits to support the requirements ofits Environmental Management Program 2 Ensures full compliance to government laws and regulations on environmental protection , ‘waste generation control and disposal 5. Ensure that waste generated from production areas are properly di ‘Am-Europharina Corporations's Waste Disposal Procedure 4. Performs internal audits on waste disposal and waste management which may affect the environment. )0sed and accounted according to é How do you manage waste from your operation? Wastes from operation is segregated, collected and disposed as per requirement by the national and local environmental monitoring ageney. Traeai and treatment of hazardous wast is eollected by a certified hazardous waste hauler and treatment facility. Hezardous waste treatment procedure repor is submited to the company, Liquid waste from process is treated and disposed by the company's water treatment facility, wherein the effluent Js regularly checked and submitted to a local environmental monitoring agency. 4 Please attach any documents relevant to Waste Recycling and Energy use 732, Packaging Are you responsible for packing? © Yes © No1.3.8. Production Chain Do you contract another company to complete any part of your processing? © Yes @ No OMP: Site Description - Other Organic Certification Programmessrer2018 Biogro: Organic Management Plan Please complete this section for all new properties. To add an OMP for a non-primary operation (for example packhouse, processing or exporting) please also complete the non-primary OMP. Note that if you are adding a new property or operation to your existing certification, extra fees may apply. 1.4 Other Organic Certifications Have you previously held or do you currently hold organic certification with another certification body? OQ Yes ® No Has your organisation ever been declined or refused organic certification by another certification body? O Yes @ No OMP: Certification Programmes Please review the Organic Management Plan (OMP) we have on fie for your operation(s) and update it if necessary. Your OMP must be an accurate description of your practices. You can update it at any time during the year. Any significant management changes must be Submitted to BioGro on this OMP and approved before the changes take place. 2.1. BioGro Programmes 2.4.4, Certification Programmes Please select BioGro programme(s): DBioGro Intemationally Accredited Certification Programme (BioGro Standards) for New Zealand and export markets OMP: Certification Programmes Please review the Organic Management Plan (OMP) we have on file for your operation(s) and update it if necessary. Your OMP must be an accurate description of your practices, You can update it at any time during the year. Any significant management changes must be Submitted to BioGro on this OMP and approved before the changes take place htositientsbiogro co nzlomplprint_view/2333 6135116/2018 2.2. Markets |n which countries are organic label claims made for your products: 2.22.1 Asia And Paciic © New Zealand © Australia © Japan O Taiwan © Singapore O Philippines O Malaysia © Thailand O Korea D Hong Kong © China 2.22. Europe © European Union (including UK) © Switzerland 223. Ametica © USA O Canada © Argentina O Brazil 224, Other hitesfclentsbiogre.conzfomplprnt_view/2333 Biogro: Organle Management Plan m3sn6i2018 Biogte: Organic Management Pan Please specify: OMP: Pest Control And Procedures - Pest Control This section relates to the environmental aspects of your property management. It includes reference to cropping and pasture land, as well as non-farmed areas such as. shelter belts, un-cropped margins, woodlots, and water sources. (Refer BioGro Standards, Module 3 — 5. Sustainable Environmental Management) 3.1. Pest Control The following questions (3.1.1. and 3.1.2.) should be answered even if you are contracting another company to process and/or pack your products. In this case, you need to answer these questions on behalf of the contract processor/packer. These questions relate to the actual manufacturing and packing. 34.1. Site Map Please provide a map of the property, or update your existing map if there have been recent changes: Details to include: + Whole areas used for certified activities, and equipment to be used + Storage (i.e. products storage, chemical storage) and administration areas Staff facilities + Inwards and outwards goods areas ‘+ Pest control materials (ie. bait station) locations * Processing flow from the receipt and storage of all ingredient/inputs through to the production and dispatch of the final products 30.2 Documents Please attach any documents regarding your Food Safety Manual and/or HACCP procedures (if applicable) Food Safety Manual and/or HACCP Procedures: NA 3.1.3. Pest Control Do you contract another company to conduct pest management at your facilities? © Yes © No hips cents biegro co nzlomp)print_view2333 atasnez018 Biogto: Organic Management Plan Please describe your pest management strategies: ‘The Engineering Dept. and a 3" party contractor conducts a pest control program on all of AMEC premises, ipes of treatments conducted are spraying, misting, sticky trap and bait station, Pest eontrl fs conducted twice mont a ts with all Conte tarer e Are your premises ever fumigated? O Yes ® No Please attach any documents relevant to your Pest control procedures (e.g. MSDS) aia Suppo Please detail your inward goods procedure(s), which ensure the integrity (identification and separation) of your certified organic ingredients/supplies: The barley powder is stored in separate area, where proper storage conditions are provided and monitored. Proper handling of materials is ensured during dispensing, processing and packaging of Barley Capsule Production of Barley capsule is processed in a dedicated facility. line clearance is performed to assure that the equipment and work atea are fiee of products, documents and materials from the previous process thal are not required for the next scheduled process, and that the equipment is clean and ready for the next schedule process i Attach Documentation: Ol confirm my staff are aware of the appropriate organic requirements and I'l keep written records of this training 3415, Service Provider Does your operation provide other companies with services? © Yes © No OMP: Pest Control And Procedures - Handling And Sale This section relates to the environmental aspects of your property management. It includes reference to cropping and pasture land, as well as non-farmed areas such asshelter belts, un-cropped margins, woodlots, and water sources. (Refer BioGro Standards, Module 3 — 5. Sustainable Environmental Management) bitpscentsiogro co nz/omp/print_viewi2333 ons162018 Biogro: Organic Management Pian 3.2. Handling And Sale 321. Transport Do you contract another company to transport your products while you retain ownership? O Yes @ No 32.2. Storage And Distribution Do you use other operators to provide storage or distribution services? O Yes @ No 32.3 Export Are some of your products exported? O Yes, we are registered as a MP! Organic Exporter © Yes, we contract an exporter © No, our products are sold in New Zealand only © Other OMP: Pest Control And Procedures - Cleaning And Parallel Production Procedures This section relates to the environmental aspects of your property management. It includes reference to cropping and pasture land, as well as non-farmed areas such as. shelter belts, un-cropped margins, woodlots, and water sources. (Refer BioGro Standards, Module 3 — 5. Sustainable Environmental Management) 3.3. Cleaning And Parallel Production Procedures 3.3.1. Cleaning Procedures Do you contract another company to clean your facilities? © Yes @ No Please describe the cleaning procedure performed prior to an organic production run: ‘tos Jcients ogra co nasompyprint_view2333 sonssri6i2018 Biogro: Organic Management Pian Proper cleaning and sanitization of aren and equipment is dne before any prodution process. Equipment parts ar issambed and washed wih iq ll purpose cleaner and wae: Equpen are arsed es ope wih water, and sanitized with purified hot water. The pars and machines Wied wi Tat hee ee oh ed Thisis checked by an inspector. Before ine 4 Crue n ace] What records of clean down are kept? Cleaning and sanitization of equipment is recorded in logbook. This is then checked by a QA inspector and {agged with an equipment clean tag with disposition if fis approved for use. Equipment clean tags are attached to the batch manufacturing record, a Please attach any documents relevant to your cleaning procedures (¢.9. MSDS, flow charts): 3.3.2. Parallel Production Do you produce or handle non-organic products, as well as certified organic products? ® Yes @ No OMP: Pest Control And Procedures - Contracted Operators This section relates to the environmental aspects of your property management. It includes reference to cropping and pasture land, as well as non-farmed areas such as. shelter belts, un-cropped margins, woodlots, and water sources. (Refer BioGro Standards, Module 3 — 5. Sustainable Environmental Management) 3.4. Contracted Operators 3.4.1. List Your Contracted Operators Please list your Contracted Operators: 1, BOAZ PEST CONTROL SERVICEShntpsiicents biog co.nzlomplprint_viw/2333 aias118r2018 Biogro: Organic Management Pian OMP: Pest Control And Procedures - Other Comments 3.5. Other Comments, Provide further details of anything you believe is of relevance to your organic certification or you wish us to know: (optional) OMP: Declaration 3.6. Declaration 3.6.1. Declaration @ ! declare that the information contained in this application is a true record of my past management practices for the period specified and a true description of my intended management over the next 12 months. Confidential information held by BioGro NZ Ltd may be disclosed to BioGro’s accreditation bodies, or if it is required to do so by law. If disclosure is a legal requirement, | will be informed of such disclosure. Name Patricia Joyce Sunglao Position Regulatory Affairs Manager Date: June 25, 20189116/2018 Biogro: Organic Management Plan -mtps:iclentsiogro conzlomplprint_viewi2333 vaisATTACHMENT 1 ORGANIZATIONAL CHART' ncaa Al =y| aeseURAy joi ut BRWIED “A aUEHY Bla80y :4q panoutty Jone, GORE “Seiceesen atom | ae SRO Dem PMU ga — Say gaa a amy “ASS mh : i | LIVED TVNOLLVZINVOUO *LOaraas | ,NOHVHoaI0o Cea AMAOUd ANVAINOD : NOLLOAS TVONVIN ALTTVADSissy ommOg| ‘uaduing -y 20011) ainsavo NSWIAVdI NOWLONGONd ehemeaa cae | Be RIVED TWNOLLYZINVONO «L9arans | ,AOuYaORIOS WNAOUd ANVAWIOD = NOLLIAS 20-20-WO-OUNVATTACHMENT 2 PRODUCT COMPLAINT BUSINESS PROCESSAM-EUROPHARMA CORPORATION eeumet No: ee ceicer Review Dae PRODUCT COMPLAINTS HANDLING erat July 30,207 Revie Face Ser Wa 00 Lof 2 ‘Sopa Doe: PRODUCT COMPLAINTS BUSINESS me PROCESS PRODUCT COMPLAINTS PROCESS FLOW STEP 1: Receiving of complaint Receipt of Complaint Rib isna Gesinass Cecaan a Seem | [ | oe ‘AES Emig ¥ ¥ ¥ Reeaies compan tu shone later eal feta ae neacion t Filo Pediel Compl / Role Repo (POR) or Log Gomplant l PoRR STEP 2: Technical Investigation | *getaseye. | [Segoe noone + Gaston of Crate Cesless |_| aaeeey ame, Catgazes™ compa |] Sirootgatan’ Sane A. Cita! eee 3 Naor & he “Gates: Fre ava * Operational aes Stpotor —_— iectos! te) ¥ Formulation & Stabitty ‘Modis! Director coordinates Medical Director! Designate aes vsitiocompsinanttorevieve | | coordnale with compinrcat a rede win a ar ‘reviews &renlace Tampering & Piterege conist media ascosarent product rn 42 hours Ninee Papa oy Date oye] Coe [armored Dar eee UA Bly Addu fighc -Ronitnel 0. Sison Olivia'Y. Liewanan dna O. Saur OA Sperter Ga sinem Mame Toa mame ‘CONFIDENTIAL DOCUMENT | Copy No Ted BTN, Date: ‘aby Decent Cnt ( i Aubied orgredae fue !AM-EUROPHARMA ‘oP-10007-01 ‘Review Date: PRODUCT COMPLAINTS HANDLING we “ ae PRODUCT COMPLAINTS BUSINESS eae OMPLAIN ao Tet | [onlin | | Sees | [= Receives product rom Mad pe eae Conducts Medical assessment Chesed isla Conducts lab or process testing; Sees iets eee eer ee come =r REISE re | | eae, oat “Form ‘process owner one ene Ne Se, ee ele ee seein ce eee {at SO "4007-AEROR case ge) 103i copesiaseinvamngccar felegeaese aay feseitee fuvicimest — Frstame —Ypmintroam renee ine ee aarae | [Boat ] [Sam aaa reaeoon | | tomes | [Sema ae ene vin 9 day OF rost eva armen etn: packaging, lead cooriates ious) oF onirtyAboad | | orbengrltic, | | odmaQe, wih PSO on fea areca | | Saleem coe ibesion wei ts eee eres Pao eee ES = ee “Re® [-———+ [tose ]}- + (eno) ete i s ie aT — | I ‘CONFIDENTIAL DOCUMENT [Copy No: mued Bz) Diter ‘Only Document and Data Control is pee eee ee i ev vertlWhole areas used for certified activities, and equipment to be usedMART 6208 SITE MASTER FILE somos AAR HAR 6 200 FACILITY oa ts ae 10 of 20 HERBAL & FOOD SUPPLEMENT AREA CE 1D FISHED GDOC we SINE ROE Prepared by: Date: 9215 Checked bys Date: $30 ‘Approved by] Date . Santiago Oya V- Licwanan CONFIDENTIAL DOCUMENT Only Document and Data Conte is Authored to reproduce and issue TSRPLALMA OA Co RRSNE BATA Cr S. RLORES 1 UN hyStorage and Administration Areas“wurst. | SITE MASTER FILE sme-oota | oT = MAR 16 2020 | ‘ACILI ae [eereacoie | ADMINISTRATION OFFICE LAYOUT CONFERENCE RM. LOBBY / CONFERENCE ROOM ADMIN. OFFICE Prepared by. Date: 7-1- | Checked by Raymunil M. Santiago ED-Foclies Supervisor ‘CONFIDENTIAL DOCUMENT (Only Document and Data Cools Authorized To reproduce 20d sueRECEIVING HALAL RECEIVING DISPATCHING FINISH Goop WAREHOUSE SIN & Fi It 5 z i 3 il § ell eI ei en, |! i Ravn, ENTINCE Sa Agy 9 "ve 1 Sty “Soy, pe 100 sre meer Propared Py Date! 250-1] Checked by Dare ae Approved byt Dates SSF Ray musi M. Santiago Virgilio CSGatduta Olivia V. Levan satis Super anr UD Manger [en cimptinee& DOC Stange mn ‘Sued By D: Bagg CONF ie ee a Roe E ENT ; ise eenInwards and outwards goods areasSITE MASTER FILE SMF-010-21 FACILITY Tam m [aaa eee | FINISHED GOOD WAREHOUS! RECEIVING HALAL RECEIVING FINISH GOOD WAREHOUSE HT Prepared By Dit Checked by Date: c= Approved iy? Date: 63-10-18 sever nt Sti Olivia V. Licuanan 119 Manager I QA Compianee & DDC Manayet ‘CONFIDENTIAL DOCUMENT | Copy No: TSBs only Document and aa Contos Atria 02 coy - svrepeduc and fae [BP] Paitin Super sePest Control Materials and LocationsLe ee wif Yj) My Hoff 7 y yy WY YY Mh fife U3 Yj, Yj Uy Ziff Yo Ui Yipwyhy yyy 7 Yi, i fll Lf Vy 2 Yj YY yy ENT & DATA CONTROL TOT RC ONT Ee wea ae z 2 = Zz < & a & 5 ‘ a 8 F S o = 5 ee ee ‘CONFIDENTIAL DOCUMENT ‘nly Document and Data Conta is ‘Autbosized a reproduce md sueei | PEST CONTROL - BAIT STATION MAP 2 LAUNDRY AREA Tom No f= ‘OP -124 AG ee = ff 4 Wy Jip YY WASTEWATER (“ZZ TREATMENT MMM, 72 1) LILLIE Wy Wii, yyy Yi Vee ie yyy ipyyy ty VLIMEEE LI, Wie 7 CHILE LLh hp pf! yy Yop Ui jj a \ LLL 1 J ee < eo | ee | GY ty SUPPLY VY — mc A LZ ea fe warenouse ///), LI Oo ENGINEERING POWER COOLING OFFICE HOUSE TOWER ‘CONFIDENTIAL DOCUMENT ‘Only Doeumment and Data Conta is Authorized to reproduce and isecia | PEST CONTROL — BAIT STATION MAP 3 Checked by: Dates poe virg Gataul ewe cong DOC Mas Toye | aed ae Mo | WARSEYG Mores [PUNT 2 iProcessing Flowa Donen Ne ai OP-19048 - OPERATING PROCEDURES [ Reision Pee Sao ia / [x 02 Lof 6 | Supetedes Doane CAPSULE PROCESS FLQW 1. PURPOSE: 1.1 To provide a detailed reference about the whole operational flow of production particularly in capsule section. 2. SCOPE: 2.1 This document shall focus on the products that are being manufactured from the liquid section particutarly from its downstream process up to upstream process, 3. RESPONSIBILITY: Production Planner Logistics personnel Liquid Personnel Quality Control personnel Quality Assurance Personnel Production Manager Bases 4, ABBREVIATIONS: 4.1 BPR - Batch Processing Record 4.2 BPK —Batch Packaging 4.3 FG - Finished Goods 4.4 WO- Work Order 4.5 QA~Quality Assurance 4.6 QC ~ Quality Control [Feaedoy | Bae Checked by: Dates, ‘Approved by Date: | (yi L AWA bey Olivia ¥. Licuanan Michael 0. Pareia Ceterina Y. Samonte i Prodution — Capsule Supervisor Producto CONFIDENTIAL DOCUMENT [Capp Np Only Document and Data Conzal Authorized t produce an issiegee irl CORPORATION [Beams — | op-19048 OPERATING PROCEDURE. [Rate [= [sae = No. 02 2of 6 ~~ D Superedes Doo CAPSULE PROCESS FLOW 5. PROCEDURE: Process Flow Description Responsibility START —— sl Releasing Pick list | Distribution of Pick List Dispensing OfRaw Materials Issuance of | Raw | Materials, | | > The created pick list for the W.O is released using the system (mig /eb2), The released pick list, BPR/BPK is submitted to Logistics in transforming the raw materials from input to output. Alll the required raw materials listed on the pick list are weighed or dispensed; Line Clearance done & checked. Upon the request of withdrawal, all the dispensed raw materials are issued 10 and received by production, Production Planner QA Specialist Dispensing Personnel Dispensing Pharmacist Dispensing Pharmacist Production Supervisor Line LeaderEffective Dae: - aaa OPERATING PROCEDURE Fe Tae z 30f 6 cORPORAT CAPSULE PROCESS FLOW Process Flow Description A ) (pee Products | for Compounding | a | Set-up compounding equipments | —+—_ Compounding | ae i Cleans and prepare all the required machines, auxiliaries, tools; Line Clearance done & checked to begin compounding. Upon receiving the approval from Supervisor, the compounder will now compound all the required materials | The QA Inspector takes samples from Responsibility Compounder Supervisor QA Inspector ‘Compounder Supervisor Line Leader QA Inspector ee | [fF the compounded powder and fills up QC Analyst * L--—~| form to be submitted to QC for assay a testing. I | | | Isthe ‘Compounded Powder passed tothe QC ‘Test? Sos [ CONFIDENTIAL DOCUMENT | Copy No: ALONTROL | OnlyDosimentmd Dax Cowl | oPy |__Authorized to reproduce and issue o2 -Te are Dee | 0P-19048 | Rade OPERATING PROCEDURE: a oo aa ; Xe o 4of 6 [SSE CAPSULE PROCESS FLOW Process Flow Description Responsibility pa el coe Cleans and prepare all the required erating tooling and auxiliaries; Line Clearance machine | done & checked to begin encapsulation. Ree Cleans and prepare all the required polishing fe; tooling and auxiliaries; Line Clearance machine _| | done Ail filled capsule are polished. The QA Inspector perform bulk Bulk Assay checking, fill up forms and takes. mad Checking samples from the de-dusted tablet submitted to QC for bulk assay Didthe caps conformed to there, specifetion Releasing of Approved Sticker | The QC analyst will release passed | sticker and Qa inspector will attach it to the container of polished capsule. © Encapsulation Operator Supervisor QA Inspector Polisher Operator Supervisor QA Inspector QA Inspector QC Analyst QC Analyst QA Inspector [ CONFIDENTIAL DOCUMENT | “Cab boemanad econ Aubotasl wha aioWy ale Ee CORPORATION [Document OP-19048 OPERATING PROCEDURE Reisen Sai CAPSULE PROCESS FLOW ‘Supeedes Doo Process Flow Description Responsibility a aaa 1 Approved bulk capsule are Line Leader eee transferred and stored to Operator eee blister batching area and re waits for blistering schedule, Cend CONFIDENTIAL DOCUMENTim Euro pharm: CORPORATION Deemer Seas Day ‘OP-19048, Review Date: OPERATING PROCEDURE [Revision Paar Sapa Bo o2 Gor 6 || Supersedes Doc No. CAPSULE PROCESS FLOW 6. REFERENCES: GMP PIC/S Guidelines 1 October 2015 7. REVIEW HISTORY: Previous | New % Change 1 Sr.No | Revision | Revision | Review | Ressonfor | ¢ooio, | Approved | sion | Date: Review: is by: No: | _No.t No.: 2 | i wa 0 | Dec 20: Initial Cop: na ©. Licuanan | Review and 1 update to align ‘ 2 0 1 | Jan2018 | Wop eich | fa | O.Licuanan format oe 1 Review and 5 2 : fe icuanan [3 1 2 | on2008 | Sante SOP wa | Oli 9. COPIES TO DISTRIBUTION SITES AND LOCATION: Refer to SOP/Document Issue Registry Form ( F-QA-066 ) 10, END OF DOCUMENT: CONFIDENTIAL DOCUMENT nly Document and Dat Con's “Athrized is reproduce and ise ACONTRO!