Contamination Control Strategy – first practical insights
GMP-Verlag Peither AG · Doris Borchert
One of the key innovations in the revised Annex 1 is the requirement for a comprehensive and overarching contamination control strategy (CCS). It should record and evaluate the various aspects and the associated accompanying measures, identify possible interactions and support a corresponding analysis of gaps or weak points in the system. The contamination control strategy is an essential strategy document for all pharmaceutical production, especially for the manufacture of sterile medicinal products.Agenda
- How far along is the implementation?
- What are the challenges involved in creating a CCS?
- Which approaches are possible?
- How long does it take to create a CCS?
- Who should be involved in its creation?