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The frequency of requalification may be determined on the basis of factors such as the analysis of results relating to calibration, verification and maintenance.10.15 There should be periodic requalification, as well as requalification after changes (such as changes to utilities, systems, equipment; maintenance work; and movement).(See also point 4.2.5 above and section 11 below.)10.23 Revalidation should be performed following a change that could have an effect on the process, procedure, quality of the product and/or the product characteristics.These guidelines aim to give guidance to inspectors of pharmaceutical manufacturing facilities and manufacturers of pharmaceutical products on the requirements for validation.The main part covers the general principles of and qualification.Worst case situations should be considered.4.2.8 There should be a clear distinction between in-process controls and validation.In-process tests are performed during the manufacture of each batch according to specifications and methods devised during the development phase.

at least three consecutive batches (full production scale) should be validated, to demonstrate consistency.Revalidation should be considered as part of the change control procedure.Changes of equipment which involve the replacement of equipment on a “like-for-like” basis would not normally require a revalidation.Whenever possible, prospective validation is preferred. Retrospective validation is no longer encouraged and is, in any case, not applicable to the manufacturing of sterile products.4.2.1 There should be an appropriate and sufficient system including organizational structure and documentation infrastructure, sufficient personnel and financial resources to perform validation tasks in a timely manner.Management and persons responsible for quality assurance should be involved.4.2.2 Personnel with appropriate qualifications and experience should be responsible for performing validation.

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