The main items typically included in a Validation Master Plan (VMP) of a epharmaceutical industry are:
1. Introduction
Provides an overview of the purpose and scope of the VMP.
2. Objective
Clearly defines the objectives and goals of the validation activities.
3. Regulatory Requirements
Outlines the relevant regulatory guidelines and requirements that need to be followed.
4. Organizational Structure
Describes the roles, responsibilities, and authorities of personnel involved in validation activities.
5. Validation Policy
States the company's policy on validation and its commitment to compliance with regulations.
6. Validation Approach
Defines the overall approach to be followed for validation, including strategies, methodologies, and acceptance criteria.
7. Validation Activities
Lists all the specific validation activities to be performed, such as equipment qualification, process validation, cleaning validation, etc.
8. Documentation Requirements
Specifies the documentation that needs to be generated during each stage of validation.
9. Change Control
Describes how changes to validated systems or processes will be managed and documented.
10. Training Requirements
Identifies the training needs for personnel involved in validation activities.
11. Risk Assessment
Outlines how risk assessment will be conducted throughout the validation process.
12. Periodic Review
Defines how periodic review of validated systems or processes will be performed.
References:
As for references on this topic, here are some recent publications related to Validation Master Plans in the pharmaceutical industry:
1. "Validation Master Plan (VMP) - A Comprehensive Guide" by Sushil Kumar Singh (2020).
2. "Validation Master Plan - The Ultimate Guide" by David Nims (2019).
3. "Pharmaceutical Quality by Design - A Practical Approach" by Walkiria Schlindwein and Dilson Ferreira (2018).
4. "Pharmaceutical Process Validation - An International Third Edition" by Robert A Nash and Alfred H Wachter (2017).
5. "Pharmaceutical Validation - An Essential Guide for the Preparation of a Validation Master Plan" by Terry Jacobs (2016)
