Site Master File or SMF is a document in the pharmaceutical industry which provides information about the production and control of manufacturing operations. The document is created by a manufacturer. It's a document prepared by the manufacturer containing specific and factual GMP information about the production and/or control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file need describe only those operations, e.g., analysis, packaging.

1. ABC 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.
7.
8.
9.
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
Employees Details
External Technical Assistance
Quality Management System

4. • PERSONNEL
1. 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

5. • PREMISES AND EQUIPMENTS
1.
2.
3.
4.
5.
6.
Description of Manufacturing Area
Nature of Construction
Brief Description on Ventilations System
Description of Water System
Maintenance of Premises
Brief Description of Major Equipments used in
Production and Laboratory
7. Maintenance of Equipment
8. Calibration system
9. Sanitation (Cleaning)

6. • DOCUMENTATION
1. Preparation, Revision and Distribution
2. Other Document Related to Product Quality
3. Additional documents
•
PRODUCTION
1.
2.
3.
4.
Brief Description of Production Operation
Handling of Materials
Handling of Rejected Material
Process Validation
• QUALITY CONTROL
1. Quality Control System

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

8. THANK YOU