Drug Product Manufacturing - GMP Validation Master Plan (VMP)

The validation master plan (VMP) is a crucial documents as it describes the basic concept for your overall site validation program.

This 25-page VMP template for manufacturers of tablets, capsules, ointments, gels, creams and inhaled products, which has been updated in line with current industry standards, needs only a small amount of site-specific modification before it can be adopted for your operations.

The VMP addresses: process validation, facility qualification and validation, utility qualification and validation, equipment qualification and cleaning validation. Its objective is to outline the principles involved in the qualification and validation of your facility, define the areas and systems that are to be qualified and validated and provide a program for achieving and maintaining validated status.

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Description

Table of Content:

1. Introduction
1.1. Background
1.2 Scope
1.3 Responsibilities
2. Description of facility
2.1 General design
2.2 Plant Layout
2.3 Building
2.3.1 Construction materials
2.3.2 Cleanliness Zone Concept
2.3.3 Room Pressure Concept
2.3.4 Storage Areas
2.4 Personnel
2.5 Personnel Flow
2.6 Material Flow
2.7 Waste Flow
2.7.1 Water waste
2.7.2 Solid waste
3. Description of Infrastructure
3.1 Utilities
3.2 Critical Utilities
3.2.1 Purified Water
3.2.2 WFI Water
3.2.3 Heating, ventilation and air-conditioning (HVAC)
3.2.4 Clean Steam, compressed air and gases
3.2.5 Vacuum System
4. Description of Manufacturing Equipment
5. Description of automated systems
5.1. Building management system
5.2 Alarm Systems
5.3 Temperature and humidity control
6. Products to be manufactured
7. Qualification/validation approach
7.1 Approach
7.2 Acceptance criteria
7.2.1 DQ –general acceptance criteria
7.2.2 IQ –general acceptance criteria
7.2.3 OQ –general acceptance criteria
7.2.4 PQ equipment–general acceptance criteria
7.3 Process Validation – general acceptance criteria
7.4 Cleaning validation approach
7.4.1 Introduction
7.4.2 Rooms
7.4.3 Manufacturing Equipment
7.4.4 Microbiological Monitoring
7.5 Computer Validation
7.6 Calibration
7.7 Maintenance
7.8 Personnel Training
7.8.1 General
7.8.2 Types of training
7.9 Change Control
8.1 Technical Project documentation
8.2 Document Numbering System
8.3 QA document review and approval
8.4 Operational Documentation (SOPs)
9. Attachments
9.1 Plan Layout including equipment
9.2 Floor plan indicating zoning concept
9.3 Pressure differential concept
9.4 Organization charts
9.5 Personnel Flow concept
9.6 Gowning Concept
9.7 Material Flow Concept
9.8 Waste flow
9.9 List of critical Utilities
9.10 List of non Critical Utilities
9.11 Purified water treatment and loop
9.12 WFI water treatment and loop
9.13 Drawing of air treatment including filters
9.14 Clean Steam, compressed air and gasses drawings for the generation, treatment and distribution loop including filters
9.15 List of SOPs relating to validation and operation
10. Distribution

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SKU Drug Product Manufacturing - GMP Validation Master Plan (VMP)

FDA-EMA

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