Prepare a Site Master File containing about 25 to 30 A4 size pages as per contents are given in Annexure.
Attach site plan, outline drawings or schematic layouts, pressure segregation as Annexure to the file.
Each page of SMF shall have the following header.
NAME PHARMACEUTICALS LIMITED
Place, State
Document No.: Effective Date:
Page x of y
Each page of SMF shall have the following footer
Prepared by: Approved by:
Date: Date:
The Site Master File shall be prepared by ___, Reviewed By _____, Approved By Director Technical and Vice President QA.
Copies of Site Master file are issued to Sr. V.P. Technical, Director Technical and V.P. QA.
Any amendment to the Site Master File shall be done only after getting prior approval from Sr. V.P. Technical, Director Technical and V.P. QA
Copies of Site Master File can be requested from GM QA.
The SMF should contain information on the following sections
a) Contents page
b) Approval page
c) Issue details
1. General information
Brief information about the firm (including name and address), relation to other sites and, particularly, any information relevant to understanding the manufacturing operations.
Pharmaceutical manufacturing activities as licensed by the national authority including validity period.
Any other manufacturing activities carried out on the site.
Name and Exact Address of the Site, Including Telephone, Fax and 24 Hrs Telephone Numbers.
Type of products manufactured on the site and information about specifically toxic, hazardous or sensitizing substances handled e.g. antibiotics, hormones, cytotoxins if any. Also, state if human and/or veterinary products are both manufactured on the site.
Short description of the site including the location and immediate environment, the size of the site, types of buildings, their ages.
A number of employees engaged in production, quality control, storage and distribution and Engineering.
Use of outside scientific, analytical or other technical assistance in relation to manufacture and analysis. Provide a brief outline of the activity being undertaken.
Short description of the quality management system of the firm responsible for manufacture.
State the Quality Policy and define the responsibility of the Quality Assurance function along with elements of the QA system e.g. organizational structure, responsibilities, procedures, processes; specifications, test methods, and other quality related data collection, audit programs (self-inspection or audits by external organizations undertaken).
2. Personnel
Organization chart showing the arrangements for quality assurance, including production and quality control. Prepare organogram up to managers/department head.
Qualifications, experience and responsibilities of key personnel. Brief details of academic qualifications, work-related qualifications and year’s relevant experience.
Outline of arrangements for basic and In-Service training and records maintained. Give brief details of the training program and include induction and continuous training. Describe how training needs are identified and by whom. Give details of training relative to GMP requirements. State the form of training e.g. in-house, external, and how practical experience is gained. Explain how retraining needs are identified. Give brief details of records kept.
Describe health requirements for personnel engaged in production.
Personnel Hygiene Requirements Including Clothing.
3. Premises and equipment
Provide a Site plan highlighting production areas along with a simple plan of each production area with the indication of scale. Label areas and annotate plan with names. Plans should be legible and on A4 sheets of paper.
Nature of construction and finishes. Provide a narrative limited to critical areas including processing and packaging areas.
Brief Description of Ventilation Systems. More details should be given for critical areas with potential risks of airborne contamination including areas for processing powders, granulation and tableting.
A brief description of water systems including schematic drawings of the system back to the main city supply system.
Description of planned preventive maintenance programs and recording system
Brief Description of Major Production and Control Laboratory Equipment with the material of construction for product contact equipment, are the equipment designed to ease cleaning. A list of equipment is not required.
Maintenance and servicing of equipment production and utility.
Describe the Qualification, Validation and Calibration activities including the Company's general policy, and protocols for qualification, prospective and retrospective validation.
Sanitation procedure: Availability of written specifications and procedures for cleaning manufacturing areas and equipment.
4. Documentation
Preparation, revision and distribution of documentation for manufacture. Describe the documentation system, responsibilities, storage of master documents, instructions for preparation of documents, a procedure for control of documents, retention time.
Any other documentation related to product quality. Describe other documents available which are not mentioned elsewhere including the Equipment specifications, Specifications for disposables i.e. cleaning materials, Standard operating procedures.
5. Production
A brief description of production operations. Describe the operations capable of being carried out at the site with the existing facilities using flow sheets and charts specifying important parameters. Technical details are not required.
Arrangements for the handling of rejected materials and products.
Describe the labeling, storage, disposal and destruction of rejected material and products.
Policy for process validation
Provide a brief outline of process validation protocol.
6. Quality Control
Description of the Quality Control system and of the activities of the Quality Control Department. Procedures for the release of finished products.
7. Contract manufacture and analysis
Description the way in which the GMP compliance of the contract acceptor is assessed.
8. Distribution, complaints and products recall
Arrangements and recording system for distribution.
Provide a brief description of Storage and Distribution Practices, conditions of storage in the warehouse.
Records and Distribution
Do the retained records permit full batch traceability from the factory to the customer, in terms of the date of sale, customer details and quantity despatched?
Handling of complaints
Define responsibilities for Logging, Classifying, and Investigation of complaints. Reports prepared, review, retention time of records.
Product recalls
Describe responsibility for product recalls, the sequence of actions for Retrieval of distribution data, Notification to customers, Receipt/segregation/inspection of returned product, Investigation/reporting of the cause, Reporting corrective action.
9. Self Inspection
Short description of the self-inspection program.
ANNEXURE
CONTENTS
|
|
S.No.
|
DESCRIPTION
|
Approval
|
|
Issue Details
|
|
1.0
|
GENERAL INFORMATION
|
1.1
|
Brief Information
|
1.2
|
Pharmaceutical manufacturing activities as licensed by National authority
|
1.3
|
Other manufacturing activities
|
1.4
|
Name and address of the site
|
1.5
|
Types of products manufactured at the site
|
1.6
|
Short Description of the site
|
1.7
|
Number of employees engaged in production, quality control, storage, and distribution
|
1.8
|
Use of outside scientific analytical services
|
1.9
|
Quality Management
|
2.0
|
PERSONNEL
|
2.1
|
Organization Chart
|
2.2
|
Qualifications, experience, and responsibilities of key personnel
|
2.3
|
Training and Records
|
2.4
|
Health requirements for personnel engaged in production
|
2.5
|
Personnel hygiene requirements including clothing
|
3.0
|
PREMISES AND EQUIPMENT
|
3.1
|
Lay out of the plant
|
3.2
|
Nature of construction and finishes
|
3.3
|
Brief description of Ventilation Systems
|
3.4
|
Special areas
|
3.5
|
Brief description of the water system
|
3.6
|
Preventive maintenance / Sanitation programs for premises and recording system
|
3.7
|
Major types of equipment in production and quality control
|
3.8
|
Maintenance: (description of planned preventive maintenance programs and recording system).
|
3.9
|
Qualifications, Validation and Calibration
|
3.10
|
Sanitation procedures
|
4.0
|
DOCUMENTATION
|
|
4.1
|
Preparation, revision and distribution of documentation
|
|
4.2
|
Any other documentation related to product quality
|
|
5.0
|
PRODUCTION
|
|
5.1
|
Brief description of production operations
|
|
5.2
|
Handling of starting materials. Packaging materials, bulk and finished products
|
|
5.3
|
Handling of Rejected materials and products
|
|
5.4
|
Policy of process validation
|
|
6.0
|
QUALITY CONTROL
|
|
6.1
|
Description of the Quality Control system
|
|
6.2
|
Functions of QC Department
|
|
7.0
|
CONTRACT MANUFACTURE AND ANALYSIS
|
|
8.0
|
DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL
|
|
8.1
|
Arrangements and recording system for distribution
|
|
8.2
|
Records and Distribution
|
|
9.0
|
SELF-INSPECTION SYSTEM
|
|
ANNEXURE – I
|
Copy of Drug Manufacturing License
|
|
ANNEXURE – II
|
Organization Chart
|
|
ANNEXURE – III
|
Plant Layouts
· Site Plan
· Ground Floor Plan
· Pressure Segregation (Ground Floor)
· Pressure Segregation (First Floor)
| |
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