SITE MASTER FILE - IAEA

1 Neptune life Sciences site MASTER FILE NEPTUNE life SCIENCES PLOT NO. 100 B,EPIP,PHASE II , THANA,BADDI ( ) PHONE NO. 09218480100 Neptune life Sciences site MASTER FILE CHAPTER INDEX PAGE 1 GENERAL INFROMATION 1 Brief Information of the firm. Pharmaceutical formulations manufacturing activities as licenced by the state drug authority. Name and exact address of the site . Any other manufacturing activity carried out on the site . Type of products manufactured on the site and any information about any specifically toxic or hazardous substances handled. Short description of the site . Number of employees.

2 Use of outside scientific / analytical / other technical assistance in relation to manufacturing / analysis. Short description of the quality management system. 1 2 2 2 3 3 4 5 5 2. PERSONNEL 9 Organization chart showing the arrangements for Quality Assurance, Including Production and Quality Control. Outline of arrangements for basic and in service training and how records are maintained. Health requirements for personnel engaged in production. Personnel Hygiene Requirements Including Clothing 9 9 9 10 3. PREMISES & EQUIPMENTS 17 Description of manufacturing area. Nature of construction and finishes. Brief description of ventilation systems. 17 17 18 Neptune life Sciences site MASTER FILE CHAPTER INDEX PAGE Special area for handling of highly toxic hazardous and sensitizing materials.

3 Brief description of water system including sanitation. Preventive maintenance program for premises. Equipments. Maintenance (description of planned preventive maintenance programmes and recording systems). Qualifications and calibration including recording system arrangement for computerized system validation. The viability of written specifications & procedures for cleaning manufacturing areas and equipment. 19 19 20 20 20 21 21 4. DOCUMENTATION 22 Arrangements for the preparation, revision and distribution of necessary documentation for manufacturing. Any other documentation related to product quality which is not mentioned elsewhere. ( microbiological control on air and water). 22 23 5. PRODUCTION 24 Brief description of productional operation using, wherever possible, flow sheets and charts specifying the parameters.

4 Arrangements for handling of starting materials, packing materials, bulk and finished products, including sampling, quarantining, releasing and storage of those. Arrangements for handling of rejected materials and products. Brief description of General policy for process validation. 24 25 26 26 Neptune life Sciences site MASTER FILE CHAPTER INDEX PAGE 6 QUALITY CONTROL 27 Description of the Quality Control System and the activities of the Quality Control Department. Process for the release of printed components and finished goods. Procedure for release of Finished Goods. Procedure for release of printed packaging material. 27 27 28 7. DISTRIBUTION, COMPLAINTS & PRODUCT RECALL 29 Arrangements and recording system for distribution.

5 Arrangements for handling of complaints and product recall. 29 30 8. SELF INSPECTION 31 Short description of the Self Inspection System. 31 9. LIST OF MACHINARY OF BETA LACTUM CAP. & TAB, NON-BETA LACTUM TAB. & CAP. AND OINTMENT SECTION. 32 Neptune life Sciences site MASTER FILE APPROVALS NAME SIGN REVISION NO. 00 Production Manager Rohit Mittal EFFECTIVE DATE MAR07 Q. C. Manager Ashok Kumar PAGE NO. 1 of 39 Director Technical Ravinder Singh CHAPTER 1 GENERAL INFORMATION Brief Information of the Firm (including name & address), relation to other sites particularly, any information relevant to understand the manufacturing operations. The Firm has established a modern facility as per GMP (Schedule M) standards to manufacture Tablet, Capsule, Dry Syrup ,Ointment and dry powder injection sections.

6 The unit is managed by experienced technical staff for production & quality control along with a team of expert technicians. The company has a Pharmaceuticals Formulation Plant located on a 9000 plot situated at Ward No. 10, Paonta Sahib. The facilities include Raw and Packing materials warehouses, Finished Goods warehouses and sections for the manufacture of Tablets (Beta-Lactum & Non Beta-Lactum), Capsules (Beta-Lactum & Non Beta-Lactum), Dry-Syrup , Ointmentsand dry powder injection All the testing of Raw, Intermediate and Finished Goods are done in our own well-equipped laboratory. It has a full-fledged utilities section. Neptune life Sciences site MASTER FILE APPROVALS NAME SIGN REVISION NO. 00 Production Manager Rohit Mittal EFFECTIVE DATE MAR07 Q.

7 C. Manager Ashok Kumar PAGE NO. 2 of 39 Director Technical Ravinder Singh The factory is situated in an open space. No factory producing obnoxious odor pollutants is adjacent to the factory. Pharmaceutical formulations manufacturing activities to be licensed by the STATE DRUG AUTHORITY. Has to be licensed by the Drug Controller, to manufacture formulations for Tablet, Capsule , Ointment and Dry powder injection Section vide Manufacturing License No. (Applied for) Commercial production will start after getting the licence. Name and exact address of the site : NEPTUNE life SCIENCES PVT LTD 100-B EPIP PHASE-II THANA BADDI ( ) PHONE NO. 09218480100 Any other activities carried out on the site No other manufacturing activity of any type is carried out in the plant premises.

8 The plant is solely dedicated in the manufacturing of products for which it is to be licensed to manufacture. Neptune life Sciences site MASTER FILE APPROVALS NAME SIGN REVISION NO. 00 Production Manager Rohit Mittal EFFECTIVE DATE MAR07 Q. C. Manager Ashok Kumar PAGE NO. 3 of 39 Director Technical Ravinder Singh Type of actual products manufactured on the site and such information about especially toxic and hazardous substances handled, mentioning the way they are manufactured. The Plant is engaged in the manufacturing of Tablets, Capsules & Dry Syrup (Beta-Lactum & Non Beta-Lactum) ,Ointments and Dry Powder Injection. Short description of the site Plant Layout: Refer Annexure I Plot Size: 9000 square Ft. The site covers square Ft.

9 And is located in the Central Excise Free Zone, Himachal Pradesh (India). The site has facilities for the production of Tablets (Beta-Lactum & Non Beta-Lactum), Capsules (Beta-Lactum & Non Beta-Lactum), Dry Syrup ,Ointments and Dry Powder Injection. The common warehouse for Packing Material is located on the first floor of the site and for dry powder injection s warehouse on ground floor. The Raw Material stores for Non Beta-Lactum are located on the first floor of the site and for Beta-Lactum are located on thethird floor of the site and for dry powder injection on ground floor. Neptune life Sciences site MASTER FILE APPROVALS NAME SIGN REVISION NO. 00 Production Manager Rohit mittal EFFECTIVE DATE MAR07 Q. C. Manager Ashok Kumar PAGE NO.

10 4 of 39 Director Technical Ravinder Singh Adequate and separate AHU have been provided for: Tablet and capsule and ointment (Non Beta-Lactum) tablet Capsules (Beta-Lactum) & Dry powder injection (Beta-Lactum) . The site has a centralized utilities section with Generators, Compressed air system and A. C. system. The with mixed bed for demineralization water and multicolumn plant for water for injection located on roof of the building. Number of employees engaged in production, quality control, storage and distribution. 1. The Plant is headed by the Production Director. The breakup of the Processing personnel by department is as follows: Production: Quality Assurance: Quality Control: Materials: Engineering: Accounts: Personnel and Administration: A total of Thirty-five (35) employees are proposed to work in the Formulation Unit.