Timeline For EU GMP Annex 1 Revision Remains Unclear
Annex 1 update: A pharmaceutical industry insider says that while Brexit has slowed the work of EMA guidance development, exceptions are Annex 1 and Annex 21, which are deemed high priority. Word has it that the controversial PUPSIT requirement has been included in the latest draft, and that the annex's next rapporteur will come from the French national competent authority.
You may also be interested in...
Despite improvements, latest EU GMP Annex 1 revision draws another round of objections to PUPSIT filter testing provision.
The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.
An industry expert tells pharmaceutical manufacturers to be aware of changes proposed for Annex 1 of the European Commission's GMP guide that affect visual inspections and particulate control for new parenteral drugs. The revision calls for stricter standards for visually screening products for defects.