Regulatory Updates In Brief
This article was originally published in The Gold Sheet
PIC/S GMP guide revised; EU GMP Annex 15 rewrite drafted; Reports OIG is preparing; Quality guidance FDA is drafting.
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European pharmaceutical manufacturers say that the European Union’s draft process validation guidance should be better aligned with the International Conference on Harmonization and FDA lifecycle approaches to process validation and that major changes are needed before it is a workable guideline. EMA issues two concept papers to revise Annex 15 and Annex 17 to reflect lifecycle approaches.
No device-related warning letters were released by the US FDA the week of 22 September.