What information should be included in the validation plan?
The validation plan should ensure the targeted planning of experimental investigations, the identification of the relevant performance parameters and acceptance criteria, and also describe and justify the use of existing knowledge and data, e.g. from test method development. For better traceability and for future similar validations, performance parameters, acceptance criteria and experimental design should be sufficiently explained and justified.
[GMP Compliance Adviser, 14. D]
Would you like to discover more?
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
