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

The final revision of EU GMP Annex 1 contains, among many other innovations and additions, a clear requirement for a contamination control strategy. This refers to a series of measures to control microbial load, pyrogens and particles, derived from the current product and process understanding, implemented to ensure process performance and product quality. The Contamination Control Strategy should include parameters and attributes related to APIs, excipient and drug product materials and components, facility and equipment operating conditions, in-process controls, final product specifications and associated methods and frequency of monitoring and control. A total of 16 elements to be considered is listed in Annex 1.

The requirement in the current Annex 1 for a CCS is the first time that an overarching concept has to be in place and been demanded of manufacturers that integrates the various contamination control measures into a coordinated concept. This concept 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 account of the fact that these measures and individual concepts interact with each other and that changes often have an impact on other areas. Like a butterfly effect.

Therefore, the ECA has prepared a guiding document to support you in drawing up such a contamination control strategy. It can be used for both, the coordination of measures for an existing plant and for the creation of a CCS for a new plant.