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Neptune Life Sciences

SITE

MASTER

FILE

NEPTUNE LIFE SCIENCES PVT.LTD.

PLOT NO. 100 -B,EPIP,PHASE - II , THANA,BADDI (H.P.)

PHONE NO. - 09218480100

Neptune Life Sciences

SITE MASTER FILE

CHAPTER INDEX PAGE

1

GENERAL INFROMATION

1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

1.9 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.

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

2.1 2.2 2.3 2.4

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

3.1 3.2 3.3

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 3.4 3.5 3.6 3.7 3.8 3.9 3.10

Special area for handling of highly toxic hazardous and sensitizing materials. 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

4.1

4.2 Arrangements for the preparation, revision and distribution

of necessary documentation for manufacturing. Any other documentation related to product quality which is not mentioned elsewhere. (E.g. microbiological control on air and water). 22
23

5. PRODUCTION 24

5.1 5.2 5.3 5.4

Brief description of productional operation using, wherever possible, flow sheets and charts specifying the

parameters. 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
6.1 6.2 6.3

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
7.1 7.2

Arrangements and recording system for distribution. Arrangements for handling of complaints and product recall.

29
30

8. SELF INSPECTION 31

8.1

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

1.1 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. 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 sq.Ft. 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. 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.

1.2 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.

1.3 Name and exact address of the site:

NEPTUNE LIFE SCIENCES PVT LTD

100-B EPIP PHASE-II THANA

BADDI (H.P)

PHONE NO. 09218480100

1.4 Any other activities carried out on the site

No other manufacturing activity of any type is carried out in the plant premises. 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

1.5 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.

1.6 Short description of the site

Plant Layout: Refer Annexure I

Plot Size: 9000 square Ft.

The site covers 11197.43 square Ft. 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. 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 R.O. with mixed bed for demineralization water and multicolumn plant for water for injection located on roof of the building.

1.7 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.

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. 5 of 39 Director Technical Ravinder Singh

1.8 Use of outside scientific, analytical or other technical assistance in

relation to manufacture and analysis. Very few analytical instruments are not available with the firm for which assistance of following reputed and competent laboratories are taken, which does not infringe legal provision.

1. SAMED LABORATIORIES LTD.

SCF - 340, II

ND FLOOR, MANSA DEVI ROAD,

CHANDIGARH

Ph: - 0172 - 2732949

0172 - 2591661

2. CHOKSI LABORATORIES PVT. LTD.

MANIMAZARA, CHANDIGARH

1.9 Short description of the quality management system

Total Quality Management is achieved by

-Confirming to Schedule M of Drugs & Cosmetics Standards -All the job functions of the company are in time with its Quality policy. Total Quality Management of the firm is looked after by a Quality Assurance Executive. All department heads, up to the Managers, maintain and follow

Quality Management System.

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. 6 of 39 Director Technical Ravinder Singh The Quality Management Assurance with the help of other personnel has the responsibility to see that all procedures are as per the standard operating procedures. Personnel competence is also assessed by the Quality Assurance Executive. The total Quality Management System is designed for 'Zero Defect Product' for which the Quality Assurance Executive is responsible. -All evaluation of procedures and validations are done by the Quality

Assurance Department.

-The factory is having its own fully equipped laboratory with almost all the In-House testing facilities of the products being manufactured. -It is also having adequate, competent Technical Staff to carry out the

Manufacturing Operations Analysis.

The Quality Assurance Department is responsible for: Preparing, issuing and updating Quality Assurance Policy. Maintaining and controlling all documentation related to technology transfer.

Audit operation to asses adequacy of QA systems.

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. 7 of 39 Director Technical Ravinder Singh Monitoring key quality indicators. The Quality Assurance Manager assigned to each manufacturing division is responsible for: Evaluating and approval of all validation protocols. Assigning AQLs to raw and packaging materials and approve final specifications.

Specifying sampling procedures.

Evaluation and approval of all final SOPs. Review and approval of all BPRs prior to release of goods for distribution to ensure compliance to GMPs during the manufacturing of any batch. Audit and approval of vendors and contract manufacturers. Evaluating and analyzing market complaints and batch recalls. Routine finished product stability. The Quality Assurance Manager is assisted by In-process Quality Assurance Officer and Quality Control Executives. The Quality Control Executive is responsible for testing of all raw and packaging materials, and finished products.

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. 8 of 39 Director Technical Ravinder Singh Specifications and Standard Test Procedures (STPs) Specifications and STPs are prepared by QC and finally reviewed and issued by Quality Assurance. In case of regulatory specifications and STPs, Department of Regulatory Affairs are consulted. Specifications and STPs are written in prescribed format with identification no., effective date and approval signatures. These are updated on any change in regulatory requirements or pharmacopoeias or change in specifications and STPs

Department of Regulatory Affairs are consulted.

Self Inspection & Quality Audits

Self-Inspection and Quality Audit is carried out with the objective to detect any shortcomings in the implementation of GMPs and recommending the necessary corrective actions. There is a team of Quality Assurance Manager, Production Manager, Engineering Manager and concerned departmental head for self-inspection. Such inspections are carried out as per defined procedure.

Vendor Development

All starting material is procured from approved vendors. In case of a new supplier, audit of the site is undertaken by the Quality Assurance manager and Materials manager and both technical and commercial strengths of the supplier are judged using standard checklist. Apart from this, there is a system for routine audits / assessment of existing suppliers on continuous basis. Similar practice is followed for suppliers of printed packing materials.

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. 9 of 39 Director Technical Ravinder Singh

CHAPTER - II

PERSONNEL

2.1 Organizational Chart showing arrangement of for Quality Assurance,

including production and quality control.

See attached sheets

2.2 Outline of arrangements for basic and in service training for record

maintenance. The company has structured a training program, which covers the entire employee. The managers are exposed to different are any programmes as per need assessed by divisional had. This activity is co-ordinated by cooperate trainings cell under the personnel manager.

Induction Programme

Personnel Hygiene & Sanitation

Manufacturing Techniques

Operation of Equipment

Cleaning Procedures

GMP Requirements

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 of 39 Director Technical Ravinder Singh

Safety

Personnel Manager maintains all training records. The records include personnel names, topics covered, venue and dates of training. An evaluation of the effectiveness of the training is done and records are maintained.

2.3 Health Requirements for Personnel Engaged in Production

Personnel which come into direct contact in the production activities are medically examined at the time of recruitment and thereafter annually or as situation demands from a competent medical practitioner. Only those persons meeting health standards and are medically fit are employed. Personnel suffering from any contagious or obnoxious diseases are not allowed to work or visit the production area.

2.4 Personnel Hygiene Requirements Including Clothing

All persons are instructed to observe good personal hygienic practices and work under good sanitary conditions, such as taking bath daily, keeping short nails and hair, clean shaven, wearing minimum jewelers and cosmetics in case of women employees etc. They are also instructed to wash their hands, legs and face, while reporting for work / entering production area after wearing factory uniform and footwear's, wash their hands thoroughly using soap also after visiting toilets. They are also trained and instructed to observe good personal habits in working area such as avoiding smoking, pan / tobacco, chewing, spitting and alcoholism etc.

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. 17 of 39 Director Technical Ravinder Singh

CHAPTER - III

PREMISES AND EQUIPMENT

3.1 Description of Manufacturing Area. Plan for manufacturing area is enclosed herewith

3.2 Nature of constructions and finishes. The building is constructed with good quality construction materials

resistant to almost all sorts of wear & tear and free from any major flaws and planned to facilitate unidirectional flow of materials. The walls are constructed of bricks, plastered to provide a hard smooth finish and painted. All floor and sealing joints are coved to avoid any sharp edges thereby eliminating dust accumulation. The floor is concrete with Kota stone and Mosaque finish flooring. The Ceiling is concrete, plastered with epoxy falls sealing with Hylex Sheets. The main plant building consists of ground , first ,second and third floor. The ground floor is having Dry powder injection section and Q.C.laboratory and Microbiology lab,On first floor central ware house for raw material and packing material,change rooms and ointment section (Non Beta-Lactum).On second floor tablet and capsule ( non-beta lactum) section.On third floor tablet and capsule and dry syrup(beta lactum) have been provided and on the half portion of the roof R.O.system and multicolumn distillation system.

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. 18 of 39 Director Technical Ravinder Singh

3.3 Brief description of ventilation systems:

Appropriate ventilation arrangements are provided in the factory. Provisions of windows exhaust fans & ceiling fans are provided in all areas except manufacturing, filling & sealing rooms. In critical operational area centralized air conditioning plant is provided. A total number of Sixteen independent Air Handling Units (AHU) have been provided in the facility:

1. Tablet Section (Non Beta-lactum)

2. Non Beta-lactum Capsules

3. Beta-lactum Tablet

4. Beta -lactum Capsules & dry syrup

5. Ointment Section

6. Blister packing

7. Strip packing

8. Alu- Alu packing (Machine is to be provided . )

9. Microbiology testing Lab including three air locks.

10. Separate A.H.U. have been provided for sterile & non sterile area of dry

powder Injection . a) Non sterile area - Vial & rubber bung washing room b) Vial Labeling & packing area c) Sterile area - Dispensing area, blending area, buffer zone, vial filling & sealing area,change room & air locks. Each process operation has it own air-handling system and has temperature & humidity controls. The corridors are also environmentally controlled and are at positive pressure as compared to the individual rooms to prevent any mixing of air / powder from each room to the corridors. Pressure balancing of each air handling system has been done to avoid any cross contamination. Each Core Process Room is supplied with controlled air passed through pre-filters having efficiency of 99% down to 5 µ followed by micron filters having efficiency of

99% down to 3 µ and finally through H.E.P.A. filters having efficiency of 99.97%

down to 0.3 µ. Separate return air ducts are provided in each room at a height of above

100 mm from the floor and are fitted with 10 µ filters at return point. Efficiency of 0.3

µ H.E.P.A. filters are determined by checking the velocity, pressure gradient of individual areas and based on the result, decision for filter changing is taken. Any major change in the design of air handling system calls for revalidations. The individual process area is designed to have a temperature varying from 210 C to 250 C are maintained. The corridors are kept at positive pressure with respect to the process cubicles 10% of fresh air taken in each re-circulation cycle of returned air. The AHU's are designed to have air changes varying from 20 to 40 per hour depending upon the process requirement.

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. 19 of 39 Director Technical Ravinder Singh All environmental parameters like Particle monitoring, HEPA filter integrity testing, Air change rates, Air pressure differentials, Temperature, Humidity and Microbiological Monitoring are checked at periodic intervals.

3.4 Special areas for the handling of highly toxic, hazardous & sensitizing

materials. No toxic or hazardous and sensitizing materials are handled in this facility.

3.5 Brief description of water system. Please see attached block diagram.

Source of Raw Water: There is municipal water and our bore water as source of raw water. The raw water is stored in a tank having capacity of 6,000 Liters. The water from this tank is passed through R.O. with mixed bed Plant. The DM water is monitored continuously for its conductivity and pH. This DM water is pumped up in stainless steel (S.S.) storage tanks of 1000 Lts Capacity. From there it is distributed to manufacturing area by S.S. pipelines. The tanks are regularly cleaned & the record of cleaning is maintained. The D. M water is used for preparing of paste for tablets and for ointments. D.M.water is pumped to multi column distillation unit to produse water for injection . This water for injection is distributed to sterile & non sterile area of powder injection section for cleaning of vials rubber bungs extra.

Neptune Life Sciences

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REVISION NO. 00 Production Manager Rohit Mittalquotesdbs_dbs11.pdfusesText_17

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