Tuesday, October 17, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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6.1.12Revalidation

The revalidation will be needed when there is a change in any equipment, facilities or process, considered significant because it affects the quality of the product / process or have implications for the GMP or the RD 1301/2006. These changes should be approved through a change control procedure. Otherwise, when the product quality review confirms that the system or process is consistently producing material meeting its specifications, there is no need for revalidation.

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