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EU GMP Annex 1 Manufacture of Sterile Medicinal Products Finally Published!

September 01, 2022



The Directorate for Health and Food Safety of the European Commission published the final version of the Annex 1 Manufacture of sterile medicinal products of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.

The Deadline for coming into operation are: 
- 25th August 2023: one year from the date of publication in Eudralex Volume 4 and, 

- 25th August 2024: two years from the date of publication in Eudralex Volume 4 for point 8.123 (related to Lyophilizers and associated product transfer and loading/unloading areas).

The EU GMP Annex 1 is one of the main documents governing the manufacturing, control and release of sterile pharmaceutical products, both terminally sterilized and aseptically filled drug products.

This Annex provides general guidance that should be used in the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying the principles of Quality Risk Management (QRM), to ensure and minimize that microbial, particulate and endotoxin/pyrogen contamination are prevented in the final product. QRM is not referred to a specific chapter but rather applies to this document in its entirety. 



- The Annex emphasizes the role of the Pharmaceutical quality system and the Quality Risk Management. 

- The Contamination Control Strategy (CCS), well detailed in the guide, should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls (design, procedural, technical and organizational) and monitoring measures employed to manage risks to medicinal product quality and safety.

- Processes, equipment, facilities and manufacturing activities should be managed in accordance with QRM principles

- Emphasis is also given to personal training which should have adequate qualifications and experience, training and behavior on the principals involved all around the manufacturing and protection of sterile products. 

- The use of rapid, alternative and automated microbiological methods is invigorated. These rapid and automated microbial monitoring methods may be adopted after validation as long as they are demonstrated to be at least equivalent to the established methodology.

- Emphasis is also strongly given on the identification strategy of microbial contaminants in the manufacturing environment. Hence microorganisms detected in grade A & B areas should be identified to species level and the potential impact of such microorganisms on product quality (for each batch implicated) and overall state of control should be evaluated. And consideration should also be given to the identification of microorganisms detected in grade C and D areas to avoid any potentially objectionable micro-organisms.

- Finally, allowing and encouraging the adoption of new ways of thinking and new analytical and process monitoring technologies that will push the Pharmaceutical industry in a new (r)evolution - And also the need for bacterial endotoxin testing is more widely and precisely addressed in this version of the Annex 1 compared to the historical one.

In bioMérieux we believe that this is a major step forward toward a better control of sterile medicinal products and the move into a new manufacturing era. That’s why our suite of innovative solutions provides rapid, highly accurate methods that can reduce risk, boost efficiency, facilitate regulatory compliance, and empower smarter data driven decision-making. Our experts are also here to support you in all the different aspects of the Annex 1 implementation to ensure the sterility of products for the benefits of patients.

(Re)discover our previous series of webinars on this topic:



Scientific Director Healthcare Business
Healthcare Business Industry Unit
bioMérieux SA, France

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