The technological and regulatory environment for sterile medicines is pushing ahead and it is important for AIRPLAN to be ready and to continue working to pivot to the changes. Annex 1 to the Guidelines for Good Manufacturing Practice (GMP) for Medicinal Products was updated in August 2022.
What is Annex 1?
Annex 1 is a document establishing the requirements for the manufacture of sterile medicinal products made in the EU and its core aim is to guarantee the safety, quality and efficacy of this type of medicinal product, reducing the risk of microbial contamination and ensuring people’s protection.
This document was updated in August 2022 to focus on improving the risk management process and pharmaceutical quality system, delivering greater control over contamination. In other words, the new-look Annex 1 implements a more detailed Contamination Control Strategy (CCS).
One of the significant changes to Annex 1 involves preventing direct contact between operators and the sterile product as far as possible. At Airplan, we strive to ensure that the engineering and procedures we follow to implement production plants and process equipment at our clients’ facilities comply with all GMP regulations, including the requirements of the new Appendix 1.
The Regulatory Affairs department attended a number of sessions organised by the Association for Clean and Parenteral Products (A3P) on CCS in Madrid in March 2023. The sessions included conferences and workshops on developing and implementing a contamination-control strategy that would allow the new Annex 1 guidelines to be rigorously understood and raise knowledge at the technical level.