The Contamination Control Strategy (CCS) as a Management Tool

How the crucial element of CCS (EC GMP Annex 1) can be used for knowledge-based decisions

The Contamination Control Strategy (CCS) according to EC GMP Annex 1 "Manufacture of Sterile Medicinal Products" represents a central element of the risk assessment to ensure the quality of a sterile or aseptically manufactured medicinal product. This strategy should also be used in the quality management system to guide decisions - based on the built up knowledge.

With the revision of Annex 1 on the manufacture of sterilia, the implementation of a CCS is an official requirement to be fulfilled. The areas to be considered in the CCS are clearly listed. 

A CCS quickly becomes a comprehensive and detailed document that can be difficult to maintain. This may not be so important for inspections by authorities or for customer audits, but it does not provide any relevant assistance in practice if it is in such a complex form.

But what is the broader objective, beyond compliance with the requirement to have a CCS ready as a document? What additional benefits can a company derive from creating and maintaining this document? How can a CCS be designed to continuously form a basis for decision-making, to become a continuous CCS (continuous CCS, or cCCS), so to speak? 

This is the subject of the new gempex article by Dr. Ann-Kathrin Nedele and Dr. Martin Melzer, published in the special issue of Cleanroom&Processes "PharmaCongress 2023" 03-2023:    

   The Contamination Control Strategy (CCS) as a Management Tool 
   
How the crucial element of CCS (EC GMP Annex 1) can be used for knowledge-based decisions

This paper introduces the concept of a continuous contamination control strategy (continuous CCS) and shows a way to design a readable, evaluable and understandable document for the CCS. This proficiency can provide decision makers with up-to-date data on the overall health of a sterile or aseptic manufacturing facility, which can then be used to make upcoming decisions.

The German language article is available for download under GMP knowledge.

If you have any questions on this topic, please contact Dr. Martin Melzer via contact@gempex.com.