本帖最后由 beiwei5du 于 2016-1-13 23:21 编辑
More than half of the participants assessed removing the routine validation (question 8) as understandable as it is replaced by the ongoing process verification. But 36.6% would still like to regularly revalidate based on a risk assessment, and 6.4% even without a risk analysis. Just as many participants will only do this in a sterile area (e.g. at Medial Fills).
The hybrid approach is also only clear to just under 50% of participants. With the request for ongoing process verification, the majority of the industry (60.4%) believes this will result in additional work, while 50% also believe discontinuing the routine revalidation will result in additional work.
from<Validation - Revision of Annex 15: How does the Industry see the Changes? - Results of an ECA Survey>
Other important changes compared to the current version are:
- There are new terms that are not explained in the glossary, such as "ongoing validation strategy"
- Retrospective validation and the notion of revalidation are gone completely - except for one exemption
- from<Revision of the EU GMP Annex 15 for Qualification and Validation published>
form<Revision of the EU GMP Annex 15 for Qualification and Validation published>
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