"To assist enhancement of sterility assurance programmes, this article highlights the main changes in the new draft Annex 1. In developing the draft, the European Medicines Agency made considerable efforts to integrate new concepts and facilitate the introduction and implementation of innovative technologies. To be proactive, it is advised that existing sterility assurance programmes be assessed against the changes to provide a gap assessment to understand the actions and resources required to align with the proposed new guidance."
The reference is:
Saghee, M. and Sandle, T. (2018) Proposed EU Guidelines to GMP Annex 1: main changes that trigger enhancements to your sterility assurance programme, GMP Review, 17 (1): 4-8
See: GMP Review
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
