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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.Validation of processes and systems is fundamental to achieving these goals.It is by design and validation that a manufacturer can establish confidence that the manufactured products will consistently meet their product specifications.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.Significant changes to the facilities or the equipment, and processes that may affect the quality of the product should be validated.A risk assessment approach should be used to determine the scope and extent of validation required.5.2 Depending on the function and operation of the equipment, utility or system, only installation qualification (IQ) and operational qualification (OQ) may be required, as the correct operation of the equipment, utility or system could be considered to be a sufficient indicator of its performance (refer to Section 10 for IQ, OQ and performance qualification (PQ)).
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Validation is an essential part of good manufacturing practices (GMP).
It is, therefore, an element of the quality assurance programme associated with a particular product or process.