ABC LAB’S PVT. LTD.

SITE MASTER FILE

SUBMITTED BY

ANWAR MUNJEWAR

M.PHARM SEM-I

QUALITY ASSURANCE TECHNIQUES

ALLANA COLLEGE OF PHARMACY, PUNE

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.

CONTENTS

• GENERAL INFORMATION1. Information about the organization

2. Pharmaceutical Manufacturing Activates

3. Other Manufacturing Activities at the Site

4. Name and Address of Site

5. Type of Product Manufactured at Site

6. Description of Plant and Site

7. Employees Details

8. External Technical Assistance

9. Quality Management System

• PERSONNEL1. Organization Chart

2. Qualification, Experience and Responsibilities of Key Personnel

3. Training (Basic and In-Service)

4. Health Requirements for Personnel

5. Personnel Hygiene requirement including clothing

• PREMISES AND EQUIPMENTS1. Description of Manufacturing Area2. Nature of Construction3. Brief Description on Ventilations System4. Description of Water System5. Maintenance of Premises6. Brief Description of Major Equipments used in

Production and Laboratory7. Maintenance of Equipment8. Calibration system9. Sanitation (Cleaning)

• DOCUMENTATION1. Preparation, Revision and Distribution2. Other Document Related to Product Quality3. Additional documents

• PRODUCTION1. Brief Description of Production Operation2. Handling of Materials3. Handling of Rejected Material4. Process Validation

• QUALITY CONTROL1. Quality Control System

• CONTRACT MANUFACTURE AND ANALYSIS

• DISTRIBUTION, COMPLAINTS AND PRODUCT RECALL

1. Arrangements and Distribution System

2. Compliant Handling

3. Product Recalls

• SELF INSPECTION1. Self Inspection System

THANK YOU