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    Efficiently documenting a Contamination Control Strategy for Cell and Gene Therapy Products

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    Preparation of a contamination control strategy can be challenging. Join our webinar series and get help from our experienced 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.

     

    A young female Quality Control Scientist is inspecting a settle plate for viable particle contaminations as in colony forming units

    Developing and documenting a Contamination Control Strategy

     

    Die Prozesse in eine GMP-konforme Umgebung zu überführen ist hier oft die erste Hürde. Die Dokumentation im pharma­zeutischen Umfeld ist anspruchsvoll und die Qualifizierung von Räumen, Geräten und Lieferanten wie auch die Validierung von Prozessen, Systemen und Methoden sind gefordert. Im Teil IV des GMP-Leitfadens für ATMP wird hier auf einen Risiko-basierten Ansatz (RBA) verwiesen.

    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.

    Visit us on July 14, 2025, at the APV Workshop on Cell & Gene Therapy Products 2025 in Berlin! We look forward to engaging with you in person to discuss the CCS and other regulatory topics related to cell and gene therapeutics.

    In addition, we will keep you updated on the CCS through an upcoming webinar series.

     

    Is the CCS a hot topic for you as well? Join our upcoming webinar series and get in touch with our experts! More information will be available soon.

     

    Authors: Dr. Claudia Papewalis, Dr. Stefan Löffler, GMP Consultants