The New EU GMP Annex 1 Draft: Impact on Environmental Monitoring Programs
On December 20th, after intensive research and debates, 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 for public comment. This updated document 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 document provides a summary of the new aspects of environmental monitoring in sterile manufacturing and its potential implications to the Pharmaceutical industry.