The Annex 1 of the European Union’s Good Manufacturing Practice (EU GMP) guidelines is a critical document that outlines the requirements for the manufacture of sterile medicinal products.
The revised EU GMP Annex 1 requirements came into force in August 2023, with significant implications for contamination control strategies, plant facilities, equipment, manufacturing processes, and quality systems.
Pharmaceutical manufacturers are expected to provide comprehensive and formal documentation of the manufacturing process, from the receipt of raw materials to the distribution of the sterile drug products.
The design and implementation of the required Contamination Control Strategy (CCS) is an intricate process, with emphasis on the importance of expertise and knowledge of the critical factors that may contribute to contamination within the manufacturing process
At CDMO Live Prasfarma will be chairing an important roundtable about Annex 1 readiness.
Dr Jordi Botet will lead a discussion that will include:
- How manufacturing can align processes with Annex 1 requirements?
- What challenges might arise during implementation, and how can they be overcome?
- What quality control measures are essential for compliance?
Prasfarma interview
Prasfarma is a company full of experts in the manufacturing of cytostatic and highly potent products (HPAPI), with a focus on oncology.
Ahead of the event we spoke to Diana Alarcón, Business Development Manager at Prasfarma to understand more about the services offered by the Barcelona-based Contract Development & Manufacturing organisation, and how they have become Annex-1 ready.
“Prasfarma has made significant investments adapting their facilities and machinery to Annex 1 requirements for the manufacturing of sterile projects. We have expanded our facilities and increased both production and analytical departments.”
Prasfarma has a reputation for working under an agile strategy. We consider our clients as our partners.
“One of our main value is our flexibility. We work on tailor-made projects and we adapted to our customer’s needs” says Diana.
Register today to join the Annex 1 roundtable at CDMO Live to learn more about how you can get ready.
Stay ahead of trends and best practices
