EU GMP Annex 1 Would Give Microbiologists A Greater Role In Sterility Assurance, Rapporteur Says
A proposed revision of the EU GMP Guide’s Annex 1 calls for microbiologists to get out of the lab and more involved in risk assessments to ensure that sterile products are free from contamination, according to the annex’s rapporteur.
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Industry groups have raised some concerns regarding the European Commission's proposed revisions to the EU’s good manufacturing practice guidelines. They want Annex 1 better aligned with other regulatory and compendial standards for cleanroom designations and water for injection. They also want the European Commission to eliminate certain filter testing requirements as well as limits for large particles in cleanrooms. Groups are also concerned about the costs of implementing certain proposed contamination controls.
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.
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