Validation master plan

According to GMP requirements, manufacturers should plan qualification and validation within a product lifecycle. Any changes in the facilities, equipment, utilities and process affecting product quality should be formally documented and the impact on validated status should be assessed. Critical computerized systems should be validated.

The validation master plan is a document where key elements of qualification and validation programme are identified and documented.

The validation master plan is based on a risk analysis which helps to determine:

  • a scope of qualification
  • list of tests
  • control points
  • sampling frequency and location
  • frequency of the requalification

The VMP should define the qualification/validation system and include or reference information on at least the following:

  • qualification and validation policy
  • the organizational structure including roles and responsibilities for conducting qualification and validation
  • summary of the facilities, equipment, systems, processes on site and the qualification and validation status
  • change control and deviation management for qualification and validation
  • guidance on developing acceptance criteria
  • references to existing documents
  • the qualification and validation strategy, including requalification

 

More detailed VMP can  contain the following:

  • title page and authorization (approval signatures and dates)
  • table of contents
  • abbreviations and glossary
  • validation policy
  • philosophy, intention and approach to validation
  • roles and responsibilities of relevant personnel
  • resources to ensure validation is done
  • outsourced services (selection, qualification, management through life cycle)
  • deviation management in validation
  • change control in validation
  • risk management principles in validation
  • training
  • scope of validation
  • documentation required in qualification and validation such as procedures, certificates, protocols and reports
  • premises qualification
  • utilities qualification
  • equipment qualification
  • process validation
  • cleaning validation
  • personnel qualification such as analyst qualification
  • analytical method validation
  • computerized system validation
  • establishing acceptance criteria
  • life-cycle management including retirement policy
  • requalification and revalidation
  • relationship with other quality management elements
  • validation matrix
  • references

For large and complex projects separate validation plans might enhance clarity. That’s why we offer:

  • Development of a general validation master plan
  • Development of a validation master plan for manufacturing lines, warehouses, laboratories, computerized systems