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 INFORMATION
1. 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
 Size and Site of area
7. Employees Details

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.

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

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

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.

• 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
Operation
2. Handling of Materials
Control of Bulk Manufacture
Packing
3. Handling of Rejected Material
4. Process Validation

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

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

Contract manufature and analysis and services
1. Contract manufature.
2. Contract analysis.
3. Contract services.
Post operational activities.
1. Product distribution .
2. Handling of product complaints.
3. Product recall.

Export of drugs
1. Product exported to different
countries.
2. Complaints and product recall if
any.

Site master file ppt

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