1. AMM LAB’S PVT. LTD.
SITE MASTER FILE
SUBMITTED BY
ANWAR MUNJEWAR
M.PHARM SEM-I
QUALITY ASSURANCE TECHNIQUES
ALLANA COLLEGE OF PHARMACY, PUNE

2. INTRODUCTION
• Site Master File (SMF) is a document, which give
a complete and factual information regarding a
site of a pharmaceutical manufacturing plant.
• The Document should not be very massive and
at the same time it should be not be very brief.

3. CONTENTS
• GENERAL INFORMATION
1.
2.
3.
4.
5.
6.
Information about the organization
Pharmaceutical Manufacturing Activates
Other Manufacturing Activities at the Site
Name and Address of Site
Type of Product Manufactured at Site
Description of Plant and Site
 Size and Site of area
7. Employees Details

4. 9. External Technical Assistance
10. Quality Management System
Quality Policy
Responsibility of Quality Assurance Function
Elements of The QA System
a) Organisational Structure.
b) Responsibilities
c) Quality Management Procedures.

5. • PERSONNEL
1. Organization Chart
2. Qualification, Experience and Responsibilities of
Key Personnel
 Name
 Education
 Designation
 Experience
 Job Responsibility

6. 3. Training
 Basic
 In-Service
4. Health Requirements for Personnel
5. Personnel Hygiene requirement including
clothing
 SOP on Clothing
 Washing, Changing and Rest rooms

7. • PREMISES AND EQUIPMENTS
1. Description of Manufacturing Area
2. Nature of Construction
 Material of Construction
 Type of Floors and Material.
3. Brief Description on Ventilations System
 HVAC System
4. Description of Water System

8. 6. Maintenance of Premises
 SOP on Maintenance
7. Brief Description of Major Equipments used in
Production and Laboratory
 List of Equipments
8. Maintenance of Equipment
 Annual Maintenance Contract (AMC)
9. Calibration and Validation System
 Validation Master Plan
10. Sanitation (Cleaning)

9. • DOCUMENTATION
1. Preparation, Revision and Distribution
 SOP, MPCR, BPCR etc.
2. Other Document Related to Product Quality
 Training Procedure.
3. Additional documents
 Planned Preventive Maintenance Records
 Medical Check up and Health Records
 Pest and Rodent Control Records.

10. •
PRODUCTION
1. Brief Description of Production Operation
2. Handling of Materials
 Control of Bulk Manufacture
 Packing
3. Handling of Rejected Material
4. Process Validation

11. • QUALITY CONTROL
1. Quality Control System
 Activities of Quality Control Department
• CONTRACT MANUFACTURE AND ANALYSIS
1. Contract Audit
2. Review Certificate of Analysis

12. • DISTRIBUTION, COMPLAINTS AND PRODUCT
RECALL
1. Arrangements and Distribution System
2. Compliant Handling
3. Product Recalls
• SELF INSPECTION
1. Self Inspection System

13. THANK YOU