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:
Posted by Dr. Tim Sandle