News
19 Feb 2014
Transport Validation: New Considerations by Annex 15
The European Commission has launched the long expected draft of the revised Annex 15 (Qualification and Validation) for public consultation.
This revision mainly takes into account changes to other sections of the EU-GMP Guide Part I, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation and changes in manufacturing technology. But also a new chapter on verification of transportation has been included.
Click here for more information.
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