Annex 1 is updated: what to expect?

But the very essence of the recommendations formulated remains intact: mastering each industrial stage of the drug's life in order to guarantee the best levels of quality and safety for patients. 

Although many prescribed guidelines are already integrated into the practices of pharmaceutical players, the new version of the document offers an additional framework that leaves little room for interpretation in many cases. domains.

High-stakes themes for the clean room

Obviously the establishment and management of a Pharmaceutical Quality System (PQS) integrating continuous improvement as a principle director remains a primary requirement that must be reinforced with an omnipresent quality risk management (QRM) approach. Industrial processes no longer constitute a sequence of stages independent of each other but rather a perpetual questioning. The underlying idea is to reflect on the relevance of actions throughout the product manufacturing cycle – from its development to its marketing – and to thus understand and master the entire manufacturing process. QRM must be integrated into the product/process life cycle and risk analyzes must be subject to periodic review.

Let us also note the importance taken by the contamination control (CCS) strategy which now encompasses all types of contamination and all stages of process whatever they may be, and at all levels of the industrial site. In addition to isolated product/process strategies, a global CCS must present the company's policy. In many aspects, the support of one's own suppliers appears to be essential in determining a robust strategy, especially as it allows a fresh set of eyes to challenge one's own practices and identify new solutions.

The other major changes boil down to the opening of Annex 1 to new technologies and various advances which now make it possible to guarantee much better levels of risk control.

A quick overview of the gap analysis results carried out by major industrial sites shows that at the publication of the first draft of Annex 1 approximately 1/3 of their practices present differences. The majority of non-compliances are concentrated around the CCS, the PQS and the QRM, the other deviations being mainly noted at the level of premises, personnel, environmental monitoring and utilities.

What are the responses of Conformat ?

Conformat has anticipated these changes and is supporting its customers on the path to this new version. Our product ranges are designed and studied to ensure complete technical and scientific mastery: physico-chemical behavior of biocides after gamma irradiation , particle release and cleanliness of textiles, effectiveness test of decontamination mats, strict normative and regulatory monitoring in all areas, validation of sterility of ready-to-use products, etc.

All of our single-use solutions are tested according to validated protocols and accompanied by certificates of analysis and/or conformity. Our innovative packaging is designed to limit the bulk of RABS and insulators. Our ranges make it possible to ensure the alternation of disinfection products, with a spectrum of activity ranging from bactericidal to sporicidal, as well as to ensure and rationalize the cleaning steps before disinfection and rinsing.

Our innovations in the field of packaging guarantee the absence of condensates leaving the autoclave or even entering the sterile zone by waterproof transfer devices for numerous consumables, essential to maintaining clean and environmental conditions.

The few examples cited above are only a tiny part of the results of the upgrade and anticipation work undertaken by Conformat. Defining a CCS is a long-term task that must be carried out with a multidisciplinary team in which your suppliers have their place. Don't let any details escape you, Conformat is here to help you.

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