Validation Master Plan - Drug Substance Manufacturing (API)

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

This 26-page VMP template for manufacturers of drug substances/active pharmaceutical ingredients, 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 Introduction
1.3 Scope
1.4 Responsibilities
2. Description of facility
2.1 General design
2.2 Plant Layout
2.3 Zoning concept
2.4 Pressure differential concept
2.5 Room design
2.6 Processing
2.7 Storage areas
2.8 Personnel
2.9 Personnel Flow
2.10 Material Flow
3. Description of Systems
3.1 Utilities
3.2 Critical Utilities
3.2.1 Portable water
3.2.2 Purified Water
3.2.3 Heating, ventilation and air-conditioning (HVAC)
3.2.4 Compressed air and gases (nitrogen)
3.2.5 Vacuum System
4. Description of Processing Equipment 
4.1 General description
4.2 Drying and Milling operations
5. Description of automated systems
5.1 Environment monitoring system
5.2 Process control system
5.3 Alarm Systems
5.4 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. Documentation
8.1 Technical Project documentation
8.2 Validation Documentation
8.3 Document Numbering System
8.4 QA document review and approval
8.5 Operational Documentation (SOPs)
9. Attachments (site specific)
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 GMP related computer systems
9.9 List of critical Utilities
9.10 List of non Critical Utilities
9.11 Purified water treatment and loop
9.12 List of all equipment detailing size and purpose
9.13 Drawing of air treatment including filters
9.14 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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More Information
SKU Validation Master Plan drug substance manufacturing (API)

FDA-EMA

What you will get: 
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.


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