Validation activities should follow a documented plan. The question is: should this be master validation plan, a master validation plan, a validation project plan or a just an SOP for validation. Do I need all of them, and if so, what is the difference? What will inspectors ask for?
As always, it is less important how you call the document, but the information should be available in any form. Inspectors want to see two things:
What is your company’s approach towards validation (in general)
What were the steps you did follow during a certain validation project (project specific)
In light of this we recommend to develop two type of documents
A high level document that describes how your company validates equipment, processes, computers, methods and so on. Such a document is typically called Validation Master Plan. It also includes information on who is responsible for what (by function, not by person’s name). Such a document should be developed for corporate, departments or sites. It also should include examples, for example which systems require validation and which do not. Such a document can also have the form of an SOP and it should be version controlled.
A validation project plan has all the details for a specific project. This includes validation steps, deliverables, a time schedule and responsibilities by person’s name. Such a plan should be derived from the validation master plan and is sometimes called master validation plan. It can have the form of template used for different validation projects. The templates should have sections on the goal of validation, terminology used for validation, what will be tested, what won’t be tested, test types to be done during this validation, test case scenarios, deviation protocols and how that will be handled, error handling and reporting, summary, acceptance criteria and sections for approval.
The US FDA does not formally require a Validation Master Plan, but inspectors will ask: what is your approach towards validation? and what steps did you take to validate a specific system? The EU GMP Directive Annex 15 formally requires a Validation Master Plan
Such plans are also extremely useful to improve efficiency and consistency of validation within an organization.