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Question of the Week

What requirements must a requalification proce­dure meet?

Various approaches are feasible for this company policy.

  • in the form of a review every three years, with evalua­tion of the changes made, deviations, etc. and as a re­sult, a derivation of the requalification
  • general requalification after a period of time x
  • general requalification after a certain number of changes
  • general requalification only after significant changes (the term significant must be defined.)

[GMP MANUAL, Chapter 6.H.2]

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