Eudralex V4 Annex 15: GMP Guidelines for Qualification and Validation, 3/15
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In March, 2015, the European Commission published a new version of Annex 15, Qualification and Validation, for EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
The new version was published due to significant changes in the manufacturing and regulatory environment since Annex 15 was published in 2001. The revisions to Annex 15 takes into account changes to other sections of the EudraLex, Volume 4, Part I, Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology.
Annex 15 now refers readers to Annex 11, Computerised Sytems, for the specific details regarding validation of computer systems.
The deadline for compliance with this version of Annex 15 was 01-OCT-2015.
| Issuing Body | European Commission |
|---|
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