SUBMITTED BY ANWAR MUNJEWAR

M.PHARM SEM-I QUALITY ASSURANCE TECHNIQUES

ALLANA COLLEGE OF PHARMACY, PUNE

AMM LAB’S PVT. LTD.

SITE MASTER FILE

• 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.

INTRODUCTION

• GENERAL INFORMATION

1. Information about the organization2. Pharmaceutical Manufacturing Activates3. Other Manufacturing Activities at the Site4. Name and Address of Site5. Type of Product Manufactured at Site6. Description of Plant and Site Size and Site of area

7. Employees Details

CONTENTS

9. External Technical Assistance10. Quality Management SystemQuality PolicyResponsibility of Quality Assurance FunctionElements of The QA System

a) Organisational Structure. b) Responsibilities c) Quality Management Procedures.

• PERSONNEL

1. Organization Chart2. Qualification, Experience and Responsibilities of

Key Personnel Name Education Designation Experience Job Responsibility

3. Training Basic In-Service

4. Health Requirements for Personnel5. Personnel Hygiene requirement including

clothing SOP on Clothing Washing, Changing and Rest rooms

• PREMISES AND EQUIPMENTS

1. Description of Manufacturing Area2. Nature of Construction Material of Construction Type of Floors and Material.

3. Brief Description on Ventilations System HVAC System

4. Description of Water System

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)

• 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.

• PRODUCTION

1. Brief Description of Production Operation2. Handling of Materials Control of Bulk Manufacture Packing

3. Handling of Rejected Material4. Process Validation

• QUALITY CONTROL

1. Quality Control System Activities of Quality Control Department

• CONTRACT MANUFACTURE AND ANALYSIS

1. Contract Audit2. Review Certificate of Analysis

• DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL

1. Arrangements and Distribution System2. Compliant Handling3. Product Recalls

• SELF INSPECTION

1. Self Inspection System

THANK YOU