Validation Master Plan

How to Write an Effective Validation Master Plan (Part 1)

What is a Validation Master Plan?

-A validation master plan (VMP) is a detailed, structured plan of work providing information for controlling all the validation work on a project.

-It should define the validation philosophy and organisation for the project.

-Additionally, clients may decide this is a useful place for documenting some of the pre-qualification activities.

-The master validation plan is a living document, not a one-time exercise. It should be modified in response to changing needs

How Detailed Should a Validation Master Plan Be?

*This section gives an overview of the sections of a validation master plan and what should be included in these sections.

-Introduction

-Aim

-Responsibilities

-Descriptions - Facility, Equipment, Utilities, Products and Manufacturing Process, Computer Systems, Validation Strategy (Including Matrix), Validation Systems (SOPs, Maintenance, Training etc.)

The Introduction - explains what the project is, where it occurs and the reason it is required. It should clearly state the central aim in the project and focus on a commitment to cGMP and validation.

The Aim -should include notification of the project team and regulatory authorities about the project, facility layout, utilities, equipment, systems and the processes that the facility is designed to house. Also, the aims should state the approach that's to be taken on the project and lay out the assorted roles and responsibilities involved.

The Responsibilities- this section should introduce the project team members (by job title) and will define the role each member will play in the project.

The Description - this section should avoid details, especially engineering detail and it should focus on highlighting cGMP related aspects. Some of the elements contained in the Description section are described below:

1. Facility

• This is a key component of the VMP. It should explain the rationale for:

-Layout

-Personnel Flow

-Product/ Components Flow

-Equipment Flow

-Area Classifications

-Finishes

• It should also include a description of how the facility will be used.
• The author should use simple bubble diagrams to indicate the corridors, rooms etc. This will help readers to have a basic understanding of the facility.
• The facility description should highlight how equipment is moved around the facility, and how it will be cleaned and stored.
• It should describe personnel access (operators, administrators, maintenance personnel etc.) and describe security measures and a method for changing regimes.
• It should give a plan for component and product storage and transportation. This should highlight the measures that will be taken to minimize risks of cross contamination.
• It should briefly describe the room finishes.
• It should give different area classifications and the reasons for these classifications. It should use bubble diagrams to indicate air pressure regimes.

2. Utilities

• Utilities must be broken into two categories: critical and non-critical. An explanation should be provided explaining each items classification.
• There should be schematic diagrams to enhance the readers understanding.
• This section should explain what each utility is used for and how and where it is generated and stored. It should also describe where the utility serves and how it is transferred. It should describe the level of refinement that is introduced along the way. A Utility Matrix is an extremely helpful element that can be added as an attachment for a complete overview.
• This section must emphasize the suitability of the materials and finishes of all product contact parts.
• It should also explain critical parameters and indicate the quality required at every point of use.

3. Equipment

• This section should list only the KEY equipment to be used in the facility. It should label each piece of equipment as critical and non-critical and explain the difference between these labels. **Critical equipment is equipment that plays a direct role in manufacturing the product.
• It should identify which equipment is new and which is pre-existing (legendry).
• It should explain the role of the equipment, cycles, critical parameters and other pertinent information.
• It should address the suitability of the materials of construction/ finishes of any product contact parts.