Inspection Readiness with Regard to the New Annex 1

The Aseptic Conference will be held again this year as part of the GMP PharmaCongress over two days. Topics include all GMP requirements directed at production equipment and work processes that have an impact on product quality and thus patient safety, as well as their implementation. The focus will be on key developments in sterile manufacturing and new technologies that will be used in the industry in the future. Case studies are used to report on regulatory developments and their implementation. 

Dr. Stephan Heck, BIPSO GmbH, and Dr. Ralf Aubeck, gempex GmbH, will report in their technical lecture

"Inspection Readiness in View of Annex 1"
on 28.03.2023

on the implementation of the new Annex 1 at BIPSO and on the influence on the inspection readiness of the plant. One of the core topics is the new requirement of a documented CCS, a Contamination Control Strategy, in many cases already implemented in parts, but so far in all cases not sufficiently detailed and applicable documented in a document. CCS should be more than just a document, it should be a tool that seamlessly relates all risk-based methodologies right through to change control, enables efficiency checks and provides the basis for the management review.

Special consideration is given to humans as one of the major sources of microbial contamination, so their training, applicable clothing procedures and overall work organization in the cleanroom are addressed. 

In the second part of the presentation, Dr. Ralf Aubeck lectures about inspections in aseptic/sterile manufacturing plants. He will highlight „on-site inspections“ in comparison to "remote inspections", which always have the disadvantage compared to on-site inspections of not providing a realistic impression of the actual situation in the plant (real world). Accordingly, the probability of finding a significant proportion of (critical) deviations is rather low.

Moreover, the authorities still have little experience with the new Annex 1 and the CCS to be installed with it. Accordingly, it is to be expected that findings due to missing or not yet fully implemented CCS will lead to serious or even to critical assessments. A sufficiently implemented CCS includes reference to the site in its entirety, to external service providers performing critical functions, and to all products manufactured at a site, including so-called slow-movers. 

More information is provided in the conference program

The gempex team of experts is available to discuss inspection readiness or Annex 1 issues via