Impact of draft Annex 1 on cleanrooms

The December 2017 draft of EU GMP Annex 1 carries implications for cleanrooms. In a new article, Tim Sandle assesses the impact on cleanrooms and controlled environments. The article appears in the journal Clean Air and Containment Review.

The abstract for the article is:

“Annex 1 of EU GMP has set the standard for sterile products manufacture for over 25 years. A new draft of the Annex was issued in December 2017 for a targeted stakeholder consultation. Given that the last major update to the guidance was almost ten years ago, considerable changes have taken place in terms of technology (the increased use of RABS and isolators, for example) and contamination control philosophies. This article assesses the primary changes set out in the draft Annex, with a focus on cleanrooms and cleanroom technology.”

The reference is:

Sandle, T. (2018) Draft revision of EU GMP Annex 1 Manufacturing of Sterile Medicinal Products for targeted consultation: implications for cleanrooms, Clean Air and Containment Review, Issue 33, pp16-18

Posted by Dr. Tim Sandle