On December 20th, 2017, the draft for a Revision of ANNEX 1 ("Manufacture of Sterile Medicinal Products") of the EU Guideline for GOOD MANUFACTURING PRACTICE for drug products and drug substances was published. This updated guidline will set a milestone for adjustments needed within European agencies overseeing drug products regulatory applications. During the creation process, the US FDA and PIC/S were consulted by and partnered with the EU on the proposal, showing the critical need to have standardized regulations reflecting the actual state of sterile pharmaceutical manufacturing.
This on demand webinar provides a summary of the new aspects of environmental monitoring in sterile manufacturing and its potential implications to the Pharmaceutical industry.
The consultation document for the new Annex 1 revision provides insight into upcoming regulatory trends. In terms of environmental monitoring content, there is significant emphasis placed on manufacturers basing their decisions on scientifically sound and historical data while applying a risk-based approach.
From a microbiology and particle contamination perspective, this document may push modern, relevant and scientifically sound monitoring methods into the pharmaceutical world, in addition to a reasonable trending approach to data analysis.
Download this webinar to:
- Get Annex 1 reviews from various industry experts
- Find out what change have been made and the impacts they will have
- Get insights and feedback from experts on the Annex 1 draft
- Learn what the updated Annex 1 might mean to your cleanroom manufacturing
- Answers to common questions