Validation Master Plan...

Information | Understanding | Best Practice.

The Validation Master Plan is a document which aims to serve a number of purposes.


i) It outlines the approach to be taken by an organization when conducting validations.

ii) It defines the rational for performing validations versus the implementation of verification activity.

iii) The validation master plan outlines the criteria for the determination of criticality which will drive the need for the validation activity.

iv) The plan provides documented evidence in terms of the performance of a validation and the results obtained.

v) It outlines the rational for any “do not validate” decisions taken.

vi) The plan provides a reference source, from which all relevant documentation can be obtained regarding the validation program in an organization, the location of all validation related documentation, e.g. protocol reports, test results, the location of any retained validation product samples, the relevant standard operating procedure, etc..

vii) The plan also defines the process requirements in terms of test criteria, calibration and maintenance requirements, cleanliness requirements, particle count criteria, etc…


Why should an organization draft and maintain a Validation Master Plan?

To assure product quality:
To assure that all the elements necessary to support product processing are qualified and proven as capable prior to commencement of any processing activities.

Regulatory compliance:
Validation is a requirement of many regulatory bodies, for example:

– the US FDA,

– the European Competent Authorities,

– the UK’s Medical Healthcare Regulatory Agency,

– the Australia New Zealand Therapeutic Products Agency (ANZTPA),

– Health Canada, etc..

– Validation provides evidence of state of control to third party auditors.


The VMP creates a disciplined approach to the development and release of products and processes:

– Serves to ensure the identification of all necessary elements and their relationship in the manufacture of products and development of processes.

– Creates an understanding of the entire process.

– The plan forces a structured and standardized approach to validation across the organization, for example, it forces equivalent approval authority levels across different organizational departments.

– It is good business practice, as it ensures a balanced consistent approach to product and process quality, reliability and safety.


The elements of the Validation Master Plan?

– A title page which clearly describes the objective of the Validation Master Plan.
– A list of the original or final approvers.
– A contents table.
– A short summary paragraph describing the validation master plan.
– Description of the facility, utility and any environmentally controlled environments.
– Outline of the scope of the plan.
– A listing of any relevant definitions.
– Details of relevant construction and engineering documentation.
– Details of any regulatory or compliance requirements.
– Details of the validation project plan, timelines, etc..
– A description of relevant process equipment.
– Details of the various Installation Qualifications, Operational Qualifications and Performance Qualifications which form part of the overall Validation Master Plan.
– Information on specific validation protocol objectives or acceptance criteria.
– Outline of the staffing requirements and competence expectations.
– Details of relevant standard operating procedures and specifications.
– Project status reports.
– Details of validation result summaries.
– Any relevant financial requirements.
– The plan will also outline details of the ongoing activities which will need to be implemented to maintain validation compliance going forward.


Validation Master Plan – Summary statement.

When all the activities outlined the Validation Master Plan have been implemented, the results detailed and reviewed, any deviations outlined and assessed for impact, individual test reports and validation protocols signed-off, a summary outcome statement will be documented.

The summary outlines the fact that all requirements have been met or not met and the acceptability of the product, process or facility in terms of ability to produce acceptable output.
Product and Process Validation Full Details

Product and Process Validation.

  • The Validation Master Plan. Performing a Gap Analysis. Validation in the Design Process. Etc..
  • How to ensure Validation efforts are aligned with potential Risks.
  • How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
  • Information | Understanding | Best Practice   >>>