Annex 1 of the GMP covers the manufacture of sterile medicinal products. The Annex 1 guidelines have been in revision since 2017, and the revised version was published on 25. August 2022. Now, companies will have time to upgrade and align their operation before the Annex comes into force until 25 August 2023.
The main changes from the previous version are that:
- The guidelines have been updated to reflect technological advances and our understanding of quality assurance.
- There is a greater emphasis on risk management.
- There is a more apparent distinction between quality control and quality assurance.
- There is a focus on continuous improvement.
These changes mean manufacturers must review and update their processes and quality control systems. In particular, they must implement a risk-based manufacturing approach and robust strategies and controls.
The benefits of these changes are that:
- Products will be of a consistently high quality
- There will be fewer product defects
- Manufacturers will be able to identify and fix problems more quickly
- The overall cost of manufacturing will be reduced.
In conclusion, these changes mean that manufacturers must ensure that their facilities and equipment meet the new standards and have adequate quality control and risk management procedures. The benefits of these changes are that they will help ensure that pharmaceutical products manufactured in the European Union meet the highest possible quality and safety standards.
You can download the revision here.
Learn more about the Annex 1 requirements for biocide qualification in this upcoming webinar: