Syntegon Virtual Pharma Expo May 2025: Aseptic Manufacturing And Packaging

The 2022 revision of EU GMP Annex 1 represents a landmark development as the first globally harmonized guideline dedicated to the manufacture of sterile medicinal products. This comprehensive framework not only reinforces the importance of contamination control and sterility assurance but also actively encourages the adoption of advanced technologies. The implementation of these guidelines has sparked widespread discussion within the pharmaceutical community, particularly around the practicalities of compliance. The “how” of meeting Annex 1’s expectations is a topic of ongoing debate, further complicated by varying interpretations from local regulatory authorities. These differing perspectives can either accelerate or hinder progress, depending on the regulatory climate in a given region.

This challenge is not limited to new manufacturing facilities. In fact, it is often more pronounced for existing operations, where retrofitting to meet the new standards can be complex and costly. Nonetheless, there is a clear expectation that companies will align their installed base with Annex 1 requirements as far as reasonably possible. This has triggered a significant wave of retrofitting projects across the industry, marking a period of transformation and adaptation in sterile pharmaceutical manufacturing.