A Site Master Plan is frequently needed to address regulatory review or inspection
requirements particularly when dealing with overseas regulatory agencies. This Plan is a comprehensive review and description of the manufacturing site.
A typical VMP may include, among others, the following sections:
1 GENERAL INFORMATION
1.1 History Overview
1.2 Pharmaceutical Manufacturing Activities as Licensed by the National Authority
1.3 Other Manufacturing Activities
1.4 Name and Exact Location
1.5 Products Manufactured at Company
1.6 Description of the Site
1.7 Number of Employees engaged in Production, Quality Control, and Distribution
1.8 Use of Outside Contractors in Relation to Manufacture and Analysis
1.9 Quality Management Systems
2 PERSONNEL
2.1 Organization Chart
2.2 Qualification, Experience and Responsibilities of Key Personnel
2.3 Outline of Arrangement for Basic and In Service Training and Records
2.4 Health Requirements for Personnel Engaged in Production
2.5 Personnel Hygiene Requirements Including Clothing
3 PREMISES AND EQUIPMENT
3.1 Description of the Product Areas
3.2 Nature of Construction and Finishes
3.3 Ventilation System
3.4 Special Areas for Handling Hazardous Materials
3.5 Water System
3.6 Maintenance and Service of the Air Handling and Water System
3.7 Description of Major Production Equipment
3.8 Maintenance and Servicing of Equipment
3.9 Qualification, Validation and Calibration
3.10 Sanitation
4 DOCUMENTATION
4.1 Preparation / Revision / Distribution of Documentation
4.2 Other Documentation Related to Product Quality
5 PRODUCTION
5.1 Production Operations
5.2 Handling of Raw Materials and Finished Product
5.3 Handling of Rejected Materials / Products
5.4 Brief Description of the General Policy for Process Validation
6 QUALITY CONTROL
6.1 Quality Control Activities
7 CONTRACT MANUFACTURE AND ANALYSIS
8 DISTRIBUTION, COMPLAINTS AND PRODUCT RECALLS
8.1 Arrangements and Recording System for Distribution
8.2 Records of Distribution
8.3 Complaints
8.4 Product Recalls
9 SELF INSPECTION
