(2003; 148 pages)
4. Qualification and validation
4.1 In accordance with GMP, each pharmaceutical company should identify what qualification and validation work is required to prove that the critical aspects of their particular operation are controlled. 4.2 The key elements of a qualification and validation programme of a company should be clearly defined and documented in a validation master plan.
4.3 Qualification and validation should establish and provide documentary evidence that:
(a) the premises, supporting utilities, equipment and processes have been designed in accordance with the requirements for GMP (design qualification or DQ);
(b) the premises, supporting utilities and equipment have been built and installed in compliance with their design specifications (installation qualification or IQ);
(c) the premises, supporting utilities and equipment operate in accordance with their design specifications (operational qualification or OQ);
(d) a specific process will consistently produce a product meeting its predetermined specifications and quality attributes (process validation or PV, also called performance qualification or PQ).
4.4 Any aspect of operation, including significant changes to the premises, facilities, equipment or processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated.
4.5 Qualification and validation should not be considered as one-off exercises. An on-going programme should follow their first implementation and should be based on an annual review.
4.6 The commitment to maintain continued validation status should be stated in the relevant company documentation, such as the quality manual or validation master plan.
4.7 The responsibility of performing validation should be clearly defined.
4.8 Validation studies are an essential part of GMP and should be conducted in accordance with predefined and approved protocols.
4.9 A written report summarizing the results recorded and the conclusions reached should be prepared and stored.
4.10 Processes and procedures should be established on the basis of the results of the validation performed.
4.11 It is of critical importance that particular attention is paid to the validation of analytical test methods, automated systems and cleaning procedures.