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The unit of Borocaps pharmaceuticals is located in H1-46, Riico Industrial area , sarna dungar Jaipur, the company is growing pharmaceutical manufacturer in India. This unit of Borocaps pharmaceuticals is a dedicated manufacturing facility for β Lactum Antibiotic formulations. The unit covers total 7780 Sq.ft. constructed area. There are three different interconnected blocks viz. Administration, Production & Ware house. The manufacturing facility has infrastructure for the production of Capsule, Dry syrups, Oral liquids. There is an in process control laboratory located In the production block. The change room for entrance of personnel of production, quality assurance for β Lactum & Non β Lactum are housed in one block with shoe racks & lockers to keep Valuable goods.

1. Name and exact address of the site : Name of company, postal address including code:Borocaps pharmaceuticals H1-46, Riico Industrial area, Sarna dungar Jaipur.302012 Rajasthan, India.

Telephone No. of contact person: Contact person Telephone Nos. : Manoj Bhargava (Proprietor). : 9214334076 (Factory) 9413134078 (Mob) 0141-2282360 (Res.)

A. Pharmaceuticals Mfg. Activities as permitted by the licensing Authority: BOROCAPS PHARMACEUTICALS is licensed to manufacture, store & distribute For sale of different formulations of capsules, Dry syrups, Oral liquids (under schedule C& C (1) and other than C& C (1) of the Indian Drugs & Cosmetics Acts & Rules, 1945) By the Drugs Controller and Licensing Authority, Rajasthan (India).

B. Any other manufacturing activities carried out the site : Apart from the activities mentioned in section A no other manufacturing activity is Carried out at the site. C. Type of product licensed for manufacture in Borocaps Pharmaceuticals Jaipur. The firm will manufacture liquid, capsules, β Lactum & Non β Lactum with Dry syrups.


C. material primary ↓ Q.checking ↓ PKG.RECEIVING / DISPATCH OF MATERIAL ↓ ---------------------------------------------------------------------------------------↓ Raw Material ↓ Quarantine ↓ Sampling ↓ Q.Formulation / Processing -------- ↓  Primary Packing  ↓  Ancillary area  ↓  Q.Store ↓ PKG.M.Analyais ↓ R.material secondary ↓  Dispensing ----.C.C.testing  ↓ o Finished goods store 3 DESCRIPTION OF THE FIRM : .

Number of employee engaged in production. Nature of construction and fixtures / fitting. The firm has also provided air handling system in liquid section With prefilter 20 micron & 5 micron primary filter. quality control. The complete building is painted By matt finish washable paint. The windows are provided fixed glass panels fitted with aluminum frame to stop the direct air.P.P. Pest control: Insect control: As per S. Material used in construction is cement. Procedure: As per S. bajri & bricks. The firm has no aseptic area For hazardous & toxic material. walls & floor are coved B. where as outer walls Are build of stones. we have an almirah.O.O. Description of planned preventive maintenance programmes for premises & of The recording system: Rodent Control: Rodent control must be done at least once in year & record maintained. C. The corners of roof. Insectoquitor is provided in production area. 4 D. storage and Distribution: . The floor is made up of Kota stone. The windows & door are made up of aluminum & provided glass panels.A. Brief description of ventilation systems.

manager & one Marketing manager. 1. Ltd. 22 Godam industrial Area Jaipur. Jaipur. M/s. Use of out side assistance in analysis: The firm has its own testing laboratory. but for some sample will be Send to M/. Sri Ram Test House Delhi. There are eleven workers including Skilled. Number of employees in production Number of employees in quality control Number of employees in storage and distribution 9. Q. 5 Quality management system: . E.A. one. Q. & Analyst Labs Pvt.C. S-P-2. in charge..The firm has one production manager. 1. Oasis Test House Ltd.

d. Each & every steps of manufacturing is documented and signed by authorized person.O.P.manager who will assign each work to responsible person. The quality management system can be renewed after suggestion of any worker or staff. The Premises should strayed with insecticides and pest control by using pesticides the Record of pest control will maintained.A.manager has appointed charge who will be responsible for testing and in process control. Q. Sanitation in the mfg. a. The firm will also fulfill packing requirements for safety & product Acceptance. manager who will be Responsible for quality management. 3.C.O. Method of manufacture and control is documented.S. Premises & equipments : Premises should be cleaned every day. Q. premises will be maintained if includes. Chemist who will be responsible for manufacturing quality. ▶ Minimize cross contaminination.1.P.A.O. for cleaning mfg. Quality :We will prepare the end product as per official books and as per in house Specification. ▶ Removal of dust. . 2.manager who will assign the responsible person.A. trade requirement to make it profitable for all. The floor should be cleaned by phenols everyday.A. has been prepared to ensure the quality management system.P. e . Specification of material is documented. Every product has master formula record. The over head tank will be cleaned at 15 days Interval & will keep the record. 6 S.manager has appointed Q. Quality policy :Regarding quality policy we have appointed Q. c. All the S. keeping. Quality Management :Regarding quality management we have Q. b. will be prepared by Q.

Bottle washing machine 2. Bottle Drier . ▶ Control of insects & pest by providing barrier & filter air 1. step of cleaning: ▶ Equipment disassembling.e. ▶ Prewash ▶ Initial wash ▶ Final rinse ▶ reassembling the equipment 7 List of machinery:We have three sections i. liquid / oral. S. general capsules & β Lactum capsules Section wise list of machinery are as follows Liquid/ oral section: 1. it includes i.e.▶ Reduction of microbial load.O.P. for cleaning equipments.

Tanks Capsule section β Lactum 1. 3. 5. Empty bottle checking board 9. D. Sachet filling machine Blister packing machine 8 OUALITY ASSURANCE: A. Filled bottle checking board 10. 8. QUALITY ASSURANCE MANAGER . 7. S. 5. Cap sealing machine 8. 3. Capsule filling Machine with change parts. 9. 6. 2. 4.C. Thermometer Capsule Counter Stripping machine with change parts. Capsule filling machine with change parts.M.C. Organizational chart showing the arrangement for quality assurance including Production & quality control. Volumetric filling machine 7.S. Mixer Conical. Filter press 6. Dehumidifier A. Stirrer 4. Mixer Conical. Thermometer Capsule Counter General Capsule section 1.Water plant 11. 2. 6. 4.3. Emulsifier 5. Dehumidifier A.

Incharge Qualification B.C.Incharge ↓ Commercial& Administration 1. M. Qualification experience & responsibilities of key personal. 1. 2.B.S. Manager Qualification B.SC. hair short. to keep the nail short. Personnel Hygiene requirements including clothing : . Apron. S no.C. Production manager is having 22 years experience of Mfg.S. Experience 20 Years 11 Health requirements for personal engaged in production : The firm has appointed M. 2. manager has assigned to prod. Quality control manager is B.e.↓ Production manager ↓ Q. Bed. wash & clean hand. Manoj Bhargava Mrs. wear head gear & Nose mask. Activities. Doctor who has checked all the employees at the time of Employment and also will check annually of each employee. Q.A. (20 years experience) & Approved in testing.B.C. Anushua Bhargava Post Production manager Q. Experience 22 Years 20 Years For Testing:S. Manager for educating the workers for health & Hygiene i. For Testing Sushil Kumar Sharma Post Q. is responsible for the all analytical activities in the laboratory. B.A. The Doctor checks the Fitness and free from infection & Contagious diseases. For Manufacturing Mr. of medicines & will be Responsible for all Mfg.A.Sc.

ft. Raw material store β Lactum. Raw material store general 2. Packing Finished Goods Production Area Raw material ↓ Office Workers entry Office staff Entry 12 Simple plan: 1. Sq.ft. 4. General Caps. Sq.-Written instruction is displaced to ensure personal hygiene in change room & Other strategic locations. Both the raw material stores for β Lactum & non β Lactum are separate and Their entries are also separate. Sq. All person wears clean body covering & head gear with nose mask All personal wear slippers provided by factory in manufacturing area & separate slippers for toilet. Ancillary Area for General Capsules. Section. ground floor is for oral liquid & capsules are on First floor. No person showing illness is allowed in manufacturing area. Premises : Factory is constructed in double story.ft.ft. . 350 280 280 113 Sq. 3.

ft. Sq. 7. Sq.ft.5.ft. 340 102 117 117 124 126 126 400 60 165 144 495 250 196 280 190 Sq. Drying Bottle room. Lab Chemical room. Sq. Instrument room. Filling Sealing of liquid / oral. ▶ Necessary documents including master formula record should prepare by Production Manager. Sq. 6. 10.ft. Sq. Room for liquid/oral.ft.ft. Change room non β Lactum 8. Sq. .ft. Sq.ft. Mfg. Primary pkg. 20. Return goods store 14. Sq. Lab.ft.ft. Secondary pkg. material store. Change room β Lactum 9.ft. Ancillary Area for liquid / oral. Finished goods store 13. 19. 15.ft. Stripping room for liquid/oral. Sq. 18. β Lactum Cap.ft. 11.ft. Washing. Sq.ft.ft. Section. 17. 16. Pkg. Sq. 13 Documentation : ▶ Every document should prepare by the quality control assurance officer with The help of production manager and analytical in charge and should revise time To time. Ancillary Area for β Lactum capsule section. Sq. material store. Office room. Sq. 12. Sq. Sq.

M. for entry of R. ▶ Flow sheet for production.O. ▶ S.O. III. ▶ Raw material register. 14 . ▶ Return goods Record. ▶ S. Documents includes the following : I. Section.O.P. ▶ S. for cleaning of storage tank.P.P. ▶ Line clearance Record. for cleaning factory premises.P. ▶ S. ▶ Rejected goods record .▶ Mfg. Arrangements for preparation. for cleaning equipments. ▶ Pkg. for cleaning outside factory.O.O. ▶ S. ▶ Swap test required for the change parts of capsule blister packing machine.M. ▶ S.P. for cleaning machinery. ▶ Distribution Record.O. Material Register. Necessary documents for the manufacture. in deducting area to quarantine area of R. ▶ S. ▶ Master formula record of every product.P. for sampling of raw materials.P. II.O. Microbiological control about Air & Water. Area should be tested at the intervals for microbial contamination.

▶ Documentation of in process control. ↓ Dedusting Area ↓ Quarantine Area ↓ . Raw Material & Pkg.M. The Raw material is dispense to the production department from the dispensing area which is also A/C. The he flow sheet will be as follows: Separate entry gate for raw material and Pkg. 15 Production : A. Parameter. samples record. ▶ Documentation of quality assurance. We have separate Dedusting area adjust to gate. After removal of dust gunny bags R. kept in Quarantine area. The Raw material room.▶ Validation of equipments. ▶ Documentation of self inspection.C. Material. ▶ Documentation of quality assurance. Material. Is A/C. After passing of raw material from Q. To maintain the temperature. Separate area for sampling in Raw material room. ▶ Ref. will kept in tested area. Brief description of production operating using wherever possible flow sheet & chart showing imp.

- Sampling Area ↓ Quarantine Area ↓ Tested passed Area ↓ Dispensing Area ↓ Production Area 16 Other essentials: Arrangements for the handling of rejected material & product : Separate partitions for rejected. Procedure for the release of finished products: Quality Control In charge ↓ Lab. Brief description of general policy for process validation : Master formula record for each product. Quality Control: Description of the quality control system & of the activities of the quality control Deptt. quarantine & tested materials. Process will validate by quality Control in charge & production in charge in writing with initials. Assistant .

2. if gets any complaints of product in market first of all should recall the entire batch from market & should be checked. Separate register for recording of Distribution of products with all details. . Separate register for complaints & recalls.A part from this there is a system for routine audits assessment of the Existing suppliers on continuous basic. 17 Distribution. Self inspection: Self inspection system is developed for each product & will be followed Strictly. In case of a new supplier. Vendor Development: All starting materials are procured form approved vendors. Loan license manufacturer: There is no loan license. complaints & product recall: 1. Arrangement for the handing of complaints & products recalls.↓ Finished goods testing After receive the pass report of finish product will be released for market. Similar Practice is followed for suppliers Of printed packing materials. Audit of site is under taken by the quality assurance manger & material manager & Both technical & commercial strength of the supplier are judged using standard Checklist .

OVERAGES FOR VITAMINS :25 To 35 % Casper Master Formula 4. EXCEPIENTS FOR CAPSULES :Lactose Starch Talcum - 3. Finally the Documents is audited by Q. ADDITINES. The batch documents (BMR & BPR) is reviewed by manager Before submitting the Documents to quality Assurance Department.Release of finished Product for sale: After completion of the manufacturing activity the batch manufacturing documents are audited by the production executive with respect to completeness & correctness of the data & information’s.A. Having found the document. PRESERVATIVES FOR ORAL LIQUIDS :Sodium Benzoate Propyl Paraben Sodium Methyl Paraben Sodium Boronopol Sorbic Acid 2. Correct and complete the batch is recommended for release for sale through a written release note to in charge ware house. OVERAGES FOR ANTI BIOTICS :- . Manager for compliance. 18 1.

IP 150 mg. ) 19 COMPOSITIONS OF SOME PRODUCTS: NAME OF PRODUCT : AMBOPAX EACH 10 ml. I. 25mg . 2 mg. or U.10 % (+ Water % if any as per I.P.P.P. I.5 mg 30mg 100 mg. CONTAINS : Calcium Carbonate (Equivalent to Elemental Calcium) Magnesium Hydroxide I. .P.P. CONTAINS: Terbutaline Sulphate Ambroxol Hydrochloride Guaiphenesin Menthol I.P. 2. Color : Brilliant Blue & Tartrazine Supra NAME OF PRODUCT : CALCI-DZ EACH 5 ml.S.P. B. I.P.

q.s. CONTAINS: Cetirizine Dihydrochloride SALWIN PLUS I. 200 I.U 20 NAME OF PRODUCT: CYPROHEP EACH 5 ml.5 mg. q. 5 mg. 2 mg. 1. CONTAINS: Cyproheptadine Hydrochloride Flavoured Syrup Base Color: Tartazine I.(equivalent to Elemental Magnesium) Zinc Gluconate (Equivalent to Elemental Zinc) Vitamin D3 Flavored Syrup Base Color: Ponceau 4R USP I.s.P. . NAME OF PRODUCT: EACH 5 ml.P.P.

P.P. CONTAINS : Chlorpheniramine Maleate Ammonium Chloride Sodium Citrate Flavoured Syrupy Base Color: Sunset Yellow Fcf I. NAME OF PRODUCT: VERCID EACH 10 ml. CONTAINS: Activated . I.5 mg 125 mg.Phenylpropanolamine Hydrochloride Paracetamol Flavoured Syrup Base Color: Sunset Yellow FCF BP.s. 55mg.5 mg. q.s. 125mg. 21 NAME OF PRODUCT: TIKORYL EACH 5 ml. 2.P. IP 12. I. q.

I.P.P. 22 . 425 mg. I.s. q. 25 mg.Methylpolysiloxane Magnesium Hydroxide Dried Aluminum Hydroxide Gel Flavored Syrup Base Color: Sunset Yellow FCF I.P. 185 mg.