Preparation of a contamination control strategy can be challenging. Join our webinar series and get help from our GMP experts.
With the entry into force of Annex 1 of the EU GMP guidelines (Eudralex Volume 4) as of August 2023, there are new requirements for manufacturers of sterile medicinal products. One of the key requirements is the provision of a Contamination Control Strategy (CCS), which is a new master document that outlines existing contamination control measures across the facility.
These requirements for the CCS are clearly defined for all GMP topics.
The design of facilities and processes to all aspects of implementation, maintenance and improvement activities needs to be considered in subsections of the CCS.
This is a particular challenge for you as a developer of cell and gene therapeutics, who is primarily concerned with developing a good, efficient product.
Developing and documenting a Contamination Control Strategy
Often the first hurdle is to transfer the processes to a GMP-compliant environment. The documentation in the pharmaceutical environment is challenging and the qualification of rooms, equipment and suppliers, as well as the validation of processes, systems and methods are required. Part IV of the GMP guidelines for ATMPs refers to a risk-based approach (RBA).
This means that for the manufacturing process of innovative cell and gene therapeutics assessments are necessary wherever GMP conditions cannot be met, e.g. starting materials to be assessed or new analytical methods.
Conclusion
The use of a CCS is also a requirement for ATMP manufacturers that regulatory authorities want to see addressed to ensure safety and sterility. Valicare provides you with an understanding of the requirements and offers you a practical approach to creating CCS and the necessary documentation.
Our offer
Are you interested in creating a CCS?
Then take part in our webinar on “One step ahead - CCS for ATMPs.”
Dr. Stefan Löffler will provide an overview of the development and documentation of a CCS in accordance with regulatory requirements and Annex 1.
Furthermore, the APV is offering a workshop in Berlin on July 14, 2025, which will focus on the development and market supply of advanced therapy medicinal products (ATMPs).
Speakers and experts from the APV focus group will share background knowledge from the strategic planning and pharmaceutical development of orphan and non-orphan drugs, facilitate an intensive exchange of expertise, and provide space for questions and discussion.
Authors: Dr. Claudia Papewalis, Dr. Stefan Löffler, GMP Consultants
