The updates to EU Annex 1 added a great deal of emphasis on microbial control. By performing gap assessments and developing thorough, site-specific contamination control strategies, companies can maintain compliance and ensure the manufacture of sterile products.
In sterile product manufacturing, current good manufacturing practices (cGMPs) are crucial for basic safety, and compliance is a business imperative. Adhering to cGMPs can help companies maintain customer trust and avoid financial loss. Fortunately, there are published, accessible documents that can help guide companies in maintaining an ethical environment and safe-for-use products.
One notable GMP guideline, Annex 1, is a European Commission regulatory document focusing on sterile product manufacturing. In 2023, EU Annex 1 updates were implemented, causing the guideline’s length to more than double. The last version was from 2009 and
went through a significant revision process, where a first draft was published for public comment in December 2017. This initial draft showed a change in regulatory
thinking, including a stronger emphasis on Quality Risk Management (QRM) principles, contamination control, and the use of modern technologies. Thousands of comments were sent to the European Medicines Agency (EMA), and another draft was made available on
February 18, 2020, this time to a targeted audience for final commenting. The final and current version became effective on August 25, 2023.
What to Expect in this Article
- ● Overview of the Annex 1 Revision
- ● GAP Assessments
- ● Development of a Contamination Control Strategy
- ● Ensuring Annex 1 Compliance in a Contamination Control Strategy
