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Regulatory Focus™ > News Articles > 2020 > 3 > EU Begins Second Consultation to Revise Annex 1 of EU GMP Guide on Sterile Drug Manufacturing

EU Begins Second Consultation to Revise Annex 1 of EU GMP Guide on Sterile Drug Manufacturing

Posted 06 March 2020 | By Zachary Brennan 

EU Begins Second Consultation to Revise Annex 1 of EU GMP Guide on Sterile Drug Manufacturing

Since 1971, Annex 1 of the EU’s good manufacturing practice (GMP) guide has helped with the manufacture of sterile medicinal products, but now the European Commission, European Medicines Agency, PIC/S and WHO are launching a second consultation on fully revising the annex and introducing the principles of Quality Risk Management (QRM).

The revised guidance notes that although QRM is not referred to in specific paragraphs, it “applies to this document in its entirety.

“Where specific limits or frequencies are written, these should be considered as a minimum requirement. They are stated due to regulatory historical experience of issues that have previously been identified and have impacted the safety of patients,” the draft guideline under consultation says.

A first consultation on the guideline was previously conducted from December 2017 to March 2018 and about 140 companies and/or organizations commented. The joint PIC/S-EMA drafting group (with WHO participation) said they processed more than 6200 lines of comments.

In addition to numerous editorial changes, differences between the first consultation document and this latest version include reworked sections on cleanroom and clean air equipment qualification, steam used as a direct sterilizing agent and additional information on barrier technologies. The section on personnel has been moved down in the document.

The updated document also includes new paragraphs discussing a table on limits for microbial contamination during qualification. And for more on the differences between the EU and US FDA cleanroom requirements, see this article (for RAPS members only).

The EC said this latest revision is intended to add clarity, introduce the principles of QRM to allow for the inclusion of new technologies and innovative processes, and to change the structure to a more logical flow.
The second targeted consultation, which runs until 20 May, aims to collect experiences on certain manufacturing steps, the EC and PIC/S said.

Sixteen organizations representing relevant stakeholders agreed to take part in the second consultation and to receive all the comments from their members, and to compile and send the comments to the European Commission. Such organizations include the European Federation of Pharmaceutical Industries and Associations, Medicines for Europe, Vaccines Europe, the Active Pharmaceutical Ingredient Committee and the Parenteral Drug Association.

Second targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4

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