The ECA Contamination Control Strategy Guide - How to use? - Live Online Training A requirement of the revised Annex 1

The latest draft of the revision of EU GMP Annex 1, among many other innovations and additions, contains the following statement:

“Contamination Control Strategy (CCS) - A planned set of controls for microorganisms, pyrogens and particulates, derived from current product and process understanding that assures process performance and product quality. The controls can include parameters and attributes related to active substance, excipient and drug product materials and components, facility and equipment operating conditions, in- process controls, finished product specifications, and the associated methods and frequency of monitoring and control.”

With the requirement of the revised Annex 1 for a “Contamination Control Strategy”, for the first time an overarching concept is demanded from the manufacturers that the various measures of contamination control are integrated into a coordinated concept that considers these measures, which are often the responsibility of different areas of the company such as production, quality assurance or quality control, in their entirety. This takes into account the fact that these measures and individual concepts interact with each other and that changes often have an impact on other areas.

The ECA has therefore produced a guide to help you draw up such a Contamination Control Strategy. It is usable to coordinate measures of an existing plant as well as to create a CCS for a new plant.