1/2 March 2023
So far, the revised Annex 1 of the EU GMP Guidance has not been published - and there is still much speculation about the implementation time after publication. But the draft versions published so far, which have also been extensively commented on, at least give an indication of what can be expected in some areas. In addition to the increased importance of Quality Risk Management (QRM) and the discussion on Pre-Use, Post-Sterilisation Integrity Testing (PUPSIT) of the filters, it is particularly striking that for the first time an overarching recording and concerted management of contamination control measures is required, called "Contamination Control Strategy" in the draft. In other words, an overarching strategy, perhaps comparable to a PQR or a quality oversight strategy.
The various measures that serve to control contamination, such as personnel hygiene and clothing requirements, cleaning and disinfection processes, environmental monitoring and ventilation technology, are often assigned to different areas of responsibility. This often makes coordination difficult, and the effects of changes in one area on other areas are not adequately recorded. The Contamination Control Strategy is intended to link these measures, to better record interactions and to facilitate an analysis of possible gaps in the system (gap analysis).
To provide assistance in the creation and documentation of such a strategy, the ECA has brought together experts from industry, laboratories, consulting and the WHO in a task force. This task force has created a guideline and a template, an example of a GAP analysis and an overview of helpful documents and official guidelines. The ECA makes this available to all interested parties free of charge.
To facilitate the application of the parts and examples for creating a CCS and to explain how it can be used to integrate your exisiting system of measures and to evaluate possible gaps, the ECA Academy offers the workshop "The ECA Contamination Control Strategy Guide - How to Use" on 26 April. In this workshop you wil benefit from regulatory authority representatives, the authors of the guide as well as from other experts introducing it in detail. All speakers will also be available for questions and a panel discussion following the workshop.
To find out more and to download a copy, please also see the information on the new CCS Guidance on the ECA Foundtion website.