0      0


EU24CEMAR1/SES212 - Impact of Annex 1 on current ISPE Sterile Baseline Guide


‐ Mar 13, 2024 2:30pm

The ISPE Baseline Guide – Sterile Product Manufacturing Facilities has been a guide for manufacturers to ensure facility and process designs are compliant and use best practices. Therefore, the impact of the Annex 1 changes to the Baseline Guide must be considered to provide guidance or proposed changes. A final GAP analysis is performed on the ISPE Baseline Guide – Sterile Product Manufacturing Facilities and the gaps identified will be shared during the presentation with clarity provided on the way forward and suggestions on optimization for both current and new sterile manufacturing process facilities. The presentation is intended to be a “fireside” chat style presentation to promote engagement with the audience to understand the assessment and key considerations of the guide review.