Significant Revisions To Annex 1 Cleanroom Standard Soon To Be Released
MHRA inspector and rapporteur Andrew Hopkins anticipates that the long-awaited revision of Annex 1 on environmental monitoring standards for cleanrooms will soon be released and offers a preview of some of the changes.
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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.
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.
Having a multilayered approach to sterility assurance is key to preventing contamination in cleanrooms, with equal attention paid to gowning, aseptic technique, engineering technique and proactive and detailed trending, says Eli Lilly official. Official also advises manufacturers to follow both USP Chapter 1116 and the EU’s Annex 1 if they want their sterility assurance programs to pass muster with inspectors and do business globally.