Thursday, 13 February 2014

Revised Annex 15: Qualification and Validation

The European Commission has published the revised Annex 15: Qualification and Validation for public consultation.
I have only took a quick glance at the new revision and it appears to have more meat on the bones - which is not surprising given that the current annex has been around since 2001.

The following are only some of the updates that I noted.

  • The numbering system has changed since the '01 version. e.g. planning for validation (section 2 in '01) is now in section 1 of the new guide.
  • Quality Risk Management is featured and ICH Q8, Q9 and Q10 are provided as examples for supporting validation and qualification tasks. Risk assessments are not seen as a once off event during planning stages, but a continuous activity.
  • People with a software engineering background will recognise the notion of conditional approvals into subsequent validation stages where certain acceptance criteria of deviations have not been met (3.1).
  • Software engineers will also recognise the concept of the new Factory acceptance test/Site acceptance test  step included prior to IQ at section 3.4 to 3.7. As a quick glance, this looks like a promising inclusion: complex technology should be evaluated at the vendor, demonstrate confirmation to the URS; support a least burdensome approach by removing duplication of tests in later stages.
  • IQ and OQ can be combined if applicable.
  • Process Validation has bee expanded upon
  • New sections for Verification of Transportation; Validation of Packaging; Validation of Utilities and Validation of Test Methods.
  • Cleaning Validation appears to have more detail.
  • There is a specific section on Re-Qualification (10)
  • Change Control is expanded, with Quality Risk management referenced.
  • The glossary has been extended.
The annex contents may change as a result of the public consultation.

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