Annex 1: Revision 2020 and ISPE Commenting
Extended Learning
Learning Level: Basic/Intermediate
Annex 1, the section of the EU GMPs that regulates the manufacturing of sterile products, has been valid in the current version since 2009. In 2017, EMA published a revised draft version for general comments. This was followed by another draft version in 2020, this time only for a targeted stakeholder consultation. As one of the stakeholders, ISPE has had the chance to provide input into Annex 1. This webinar will explain the process of the 2020 commenting, including the collaboration with other industry organizations like PDA, PHSS, EFPIA and many others. The webinar will also touch on the most relevant paragraphs that ISPE commented on.
Learning Objectives
- Understand the current status of commenting on Annex 1
- Understand the most relevant topics in Annex 1 and ISPE’s position in the commenting
- Consider the application of the revised Annex 1 on the operation of facilities for sterile products
