Definition
A Validation Master Plan (VMP) is a document providing information about the company’s validation program. This document must
contain details of the validation and the timeframes for the studies
to be performed. There must be clear statements regarding who is responsible
for each part of the validation program.
The WHO guidelines define VMP as “A high-level document that
establishes an umbrella validation plan for the entire project and summarizes
the manufacturer’s overall philosophy and approach.”
It is important to note the situations in which the words
‘validation’ and ‘qualification’ are to be used. When a system or equipment is
the focus of the exercise, it is known as ‘qualification’.
When a process is the focus of the exercise, it is known as
‘validation’. For example, one may qualify a spray dryer, and validate a drying
process; similarly, an autoclave is qualified but the sterilization process is
validated.
Purpose of VMP
The main purpose of the VMP is to give a comprehensive
overview of the complete validation operation, how it has been organized, what it
will cover, and the validation plan.
• It helps management understand how much time will be required, the personnel involved, and expenses expected to be incurred.
• It informs members of the validation team about their jobs
and responsibilities.
• It helps inspectors/auditors to understand the company’s
approach to validation activities.
Who should write the VMP?
The best VMP is a result of a team-writing effort because it
ensures a representation of the perspectives of different departments involved
in the operations. When people from diverse areas of the operation are
involved, it is more likely that all possible angles of approaching the VMP are
covered. A VMP must be as lengthy as required to convey all the necessary
information to ensure a successful validation program.
Elements of a Good VMP
Validation Master Plans must contain the following
information at the very least:
• Company’s validation policy.
• Organizational structure.
• List of items to be validated.
• Brief outline of systems, equipment, facilities, and
processes to be validated.
• Formats for documenting protocols and test reports.
• Planning and scheduling of validation activities.
• Change control procedure.
• Training requirements for the validation team.
• Details of persons responsible for each stage of
validation – preparing the plan, drawing up protocols and standard operating
procedures (SOPs), actual validation work, preparation and control of reports
and documents, approval of validation protocols and reports at every stage of
validation, a system for tracking validation, training requirements for
validation team.
Contents of a VMP:
1. Title page with document number version information, and
authorization in the form of approval signatures.
2. Table of contents listing out critical areas of the VMP.
3. Glossary to define technical terms and abbreviations.
4. Plan for validation – details of the process steps,
critical parts of the process that impact product quality what is to be
validated, when, where, how, and why.
5. Management’s approach to validation.
6. Scope of the validation – what will be covered under
validation (and what will not be covered too).
7. Roles and responsibilities of the different departments
(validation team, manufacturing department, engineering department, Quality
Assurance department, etc.) for each of the activities involved.
8. Services to be outsourced to outside vendors.
9. Deviation management – how to document, investigate, and
deal with deviations that may be encountered.
10. Change control procedures.
11. Risk management policy.
12. Training of personnel.
13. Validation matrix that outlines the validation required
throughout the manufacturing facility in the order of most to least critical.
14. References – documents that guide the validation
process.