How should the qualification be documented?
The key elements of qualification and validation should be described in an overarching validation master plan (VMP). The qualification of individual plants is documented in the form of qualification protocols and reports. The relationship between the documents must be clearly recognisable, e.g. by the assignment of code numbers. The general requirements for GMP compliant documentation according to Chapter 4 of the EU GMP Guide apply. In the case of electronic documentation handling, the requirements of Annex 11 must also be observed. A binding retention period is not defined, but it is recommended to apply the same standards as for the batch documentation.
[GMP Compliance Adviser, Chapter 6.A]
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