Have you ever wondered why inspectors are eager to look at your validation master plan? It's because a good validation master plan gives them a clear overview of your site’s validation activities, like the products, processes, systems, equipment, facilities, and utilities you're using.
The plan also helps inspectors understand the risks to your products, how you've prioritized these risks, and what steps you’re taking to minimize them. The validation plan, along with its execution and records, builds trust with regulators, showing them that your products, processes, and systems are reliable.
If you work in the pharmaceutical industry, regulatory authorities require you to develop, implement, and regularly review a validation master plan. This plan should cover the qualification of your systems, processes, cleaning methods, testing methodologies, equipment, and facilities.
This article will help you understand who is responsible for creating the validation master plan, the stages of the validation life cycle, how to prioritize validation tasks based on risk, how to prepare a validation schedule, and offer some practical examples.
What is a Validation Master Plan (VMP)?
A Validation Master Plan (VMP) is a strategic document that outlines what needs to be validated, how it will be done, who is responsible, and how validation documentation will be maintained.
A VMP provides a comprehensive overview of all the validation activities your site needs to conduct over a certain period (like 12 or 24 months).
The VMP should include:
- What items need to be validated or qualified
- Schedules for validation
- Standards and guidelines to follow
- Roles and responsibilities in the validation process
- How to prepare, execute, and report validation protocols
- Guidelines for the format of validation documents
The plan should explain how you will manage different validation activities, including any that might be interconnected. It should detail the timelines for completing the validation tasks. The plan serves as a framework to ensure all critical processes, equipment, and systems meet the desired quality and safety standards consistently.
In short, the validation master plan is the foundation for all validation activities at your facility.
Guideline to follow for Preparation of VMP
Some common sources of reference for preparation of VMP are:
- Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme: PIC/S (PI 006)
- World Health Organization: WHO TRS 961 annex 9
- World Health Organization: WHO TRS 1019 annex 3
- European Union: Eudralex Volume 4
- The International Society for Pharmaceutical Engineering (ISPE) Baseline Guide: Commissioning and Qualification
- The US Food and Drug Administration (FDA) Guidance for Industry: Process Validation: General Principles and Practices
- The European Commission (EC) Annex 15: Qualification and Validation
These documents provide general principles and recommendations for planning, conducting, and documenting validation activities.
Importance of Validation Master Plan
VMP is a roadmap of validation activity like facility qualification and also define system and area to be validated. VMP justifies the strategy, documenting the necessary program. It’s a “high level” document which provides a written program to ensure a continuing state of validation. We can say VMP is achieving and maintaining qualified facility.
All Validation program is mention in VMP. In simple language we can describe the major element of “Validation program”
- Tell them what are you going to do
- Do it
- Tell them what you did
VMP Preparation Guideline
VMP document shall contains following information:
- Approval page: It indicates agreement with the qualification and validation annual plan. Quality assurance shall prepare VMP and checked by Production, Quality Control, warehouse & engineering personal. Document shall review by QA and approved by QA Head.
- Introduction: Describe about company example Location, formulation section and market address.
- Objective: The validation master plan (VMP) describe the company’s intentions. This Validation Master Plan (VMP) describes the company’s intentions regarding the validation of equipment, instruments, systems, utilities, facilities, materials, analytical methods, processes and personnel.
Validation Policy
Validation Team
- Organization & Responsibilities: write department name and responsibility assigned. Mention Organizational Structure of Validation Team.
- Definition of validation concept: Define Prospective Validation, Concurrent Validation, Retrospective Validation and revalidation. Also include possible reason for starting the revalidation. Include periodic revalidation.
Change control
Outline for process validation program
- Acceptance criteria: A list of the general acceptance criteria for the validation tasks must comply to concisely define the completion of validation tasks. If possible, at this stage of project, specific acceptance criteria should be developed for each unit to be validated.
- Facility description: Describes facility and shall mention critical and non-critical classification.
- Element of Equipment Validation : Mention Facility Qualification, Equipment Qualification (DQ, IQ, OQ, PQ), Computer system Qualification / Validation, Calibration, Calibration Policy, Preventive maintenance program, Process Validation, Criteria of Process Validation, Process Validation Parameter, Variable parameters, Evaluation parameters, Acceptance criteria, Approach, General Protocol, Cleaning Validation and approach, Heating Ventilation Air Conditioning (HVAC system) qualification, Pharmaceutical compressed Air, test function and acceptance criteria, Water generation and distribution system, Media fill, control of validation document.
- Revalidation: Planning and Scheduling. Validation schedule is the last but not the least important component of overall validation activity.
ALSO READ: Checklist for Analytical Method Validation
Qualification/Validation Report
A report that cross-references the qualification and/or validation protocol should be prepared, summarising the results obtained, commenting on any deviations observed, and drawing the necessary conclusions, including recommending changes necessary to correct deficiencies. Any changes to the plan/procedure as defined in the protocol should be documented with appropriate justification.
Deviation
Any deviations / critical changes to the approved protocol during the execution of process validation shall be handled as per handling of deviation procedure. Details of deviation shall be documented in the report with details such as, description of deviation, reason / cause, corrective and preventive action, and status of the deviation.
All the deviations shall be closed or resolution shall be specified prior to release of product for intended purpose.
Deficiency (If Any) and Corrective Action Report
During validation or qualification if any deficiency shall be observed, then following things must be recorded such as
- Description of deficiency and date observed
- Person, Responsible for corrective action and date assigned
- Corrective actions taken and date conducted:
These are always approved by HOD of Quality Assurance.
Addendums to Protocols
Addendums are used during execution of a protocol in five instances:
Addendums are utilized to record additional data/test not initially written into the protocol, but will enhance the validation of the System/Equipment. Addendums are utilized when a test was inadvertently left out of the initial protocol writing and the test is necessary to enhance the validation of the System/Equipment.
Addendums are utilized if a test initially written into the protocol cannot be performed or must be changed. The Addendum is utilized for detailing the new test and recording the data. Use of the Addendum in this manner requires approval by the Validation Taskforce leader prior to implementation and execution.
Addendums are utilized when more space is required to completely record data and/or comments. The Addendums require the protocol name, protocol number, execution date, signature of the preparer, date, and signature of the approver and date.
Conditional Final Report (CFR)
The conditional Final Report (CFR) is utilized in a circumstance when the portion of the validation effort impacting equipment, systems, and/or processes needed to complete scheduling deadlines is completed within the acceptance criteria limits, but the entire protocol is not completed and approved.
The CFR provides conditional approval for use of the specific area of the equipment, system, or process required by the schedule. The CFR summarizes the observations, data, deviations, conclusions, and recommended actions resulting from execution of the specific area of the appropriate protocols for the equipment, system, or process being following departments or their designees as applicable:
- Engineering,
- Production,
- Quality Assurance,
- Quality Control, and/or
- Research and Development.
The conditional review of the validation testing, take place during “sign off ” of results. CFR or FR is only a compilation of the signed off results.
Attachments
Site Plan,
Process flow chart,
Qualification Matrix,
URS Protocol,
PQ Variable,
Validation Activities (Validation Planner),
Process Validation Protocol,
Process Validation Parameter,
SOP list and Validation deliverables/responsibilities for equipment’s and utilities other than QC instrument.
The VMP is a controlled document. Its will be reviewed once in two year, layout will be generate by autocade and any changes in VMP can be made through document control.
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Validation
