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1 According to GMP, each pharmaceutical company should identify what qualification and validation work is required to demonstrate that critical aspects of their specific operations are controlled.
2 The key elements of a company’s qualification and validation program should be clearly defined and documented in a validation master plan.
3 Competence and validity should establish and provide documentary evidence that:
(a) the premises, ancillary utilities, equipment and processes are designed in accordance with the requirements of GMP (Design Qualification or DQ);
(b) the premises, ancillary utilities and equipment are constructed and installed in accordance with their design specifications (installation qualification, or IQ);
(c) premises, ancillary utilities and equipment operate in accordance with their design specifications (operational qualification, or OQ);
(d) A specified process will consistently produce a product that meets its predetermined specifications and quality characteristics (process validation, or PV, also called performance qualification or PQ).
4 Any aspect of operations, including significant changes to premises, facility ties, equipment or processes, which may directly or indirectly affect product quality, should be qualified and verified.
5 Eligibility and validity should not be considered as one-off exercises. An ongoing program should follow their first implementation and be based on an annual review.
6 The commitment to maintain continued validation status should be noted in relevant company documentation, such as the quality manual or validation master plan.
7 Responsibility for performing validation should be clearly defined.
8 Validation studies are an essential part of GMP and should be conducted according to predetermined and approved protocols.
9 A written report summarizing the documented findings and conclusions should be prepared and preserved.
10 Processes and procedures should be established based on the results of the validation performed.
11 Paying particular attention to the validation of analytical test methods, automated systems and cleaning methods is crucial.
