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.

The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.