EU Issues Plans For Significant Changes To Manufacturing Standards For Sterile Medicines
Executive Summary
Long-awaited plans to change the EU guideline on manufacturing standards for sterile medicinal products are out for consultation. The proposals were drafted in cooperation with the World Health Organization and the international pharmaceutical inspectorate group, PIC/S, to ensure global alignment of standards.
You may also be interested in...
Sterile Drug GMPs: CCS Tool Could Help Bridge Compliance Gaps As Annex 1 Revisions Take Effect
Experts who led PDA’s interactions with EU, PIC/S and WHO authorities on first-ever comprehensive revision of sterile drug product manufacturing guidance recently shared insights on implementation priorities with the Pink Sheet.
EU GMP Annex I Proposal Would Maintain PUPSIT, Relax WFI Restrictions
The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.
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.