Contamination Control Strategy – what use for improved control and benchmarking of hospital compounding?

6 October 2023

J Hargreaves (Pontrieux - France)

The August 2022 revision of Annex 1 of the EU, PIC/S and WHO Good Manufacturing Practices, governing manufacture of sterile medicinal products, introduced the notion of Contamination Control Strategy (CCS) as a single policy document setting out a site or establishment policy to achieve and maintain effective contamination control. The document is also seen as a means of justifying particular approaches and means of control proven to be relevant and effective.
Are there any application opportunities, or lessons to be learned, from this GMP document, for hospital compounding and other clean/sterile/toxic activities?
The current context of GMP development is a balancing act between opening the regulation of safety-critical and highly technical pharmaceutical activities to current and future technological and scientific innovation, while at the same time facilitating helping inspectors and auditors to assess the reliability and robustness of innovations or special means, within a reasonable timeframe for inspection. This challenge is essential, after decades of technical conservatism, causing increasing difficulties to innovate without deforming new technologies to comply with outdated assumptions and criteria.
The CCS concept aims at creating a single document, subject to facility-wide evaluation and continuous improvement, which will set out reliable and proven means to solve contamination control challenges. As such, it aims to encourage interdisciplinary discussion and research/evaluation within an establishment and between applications, and to pass on reliable information, to be tried and tested anew in similar applications. A CCS file is not a repository of simple and blanket solutions, to be applied to any new challenge, and aims to encourage users to think more deeply about what they are trying to solve, how and why, and to prove adequate control. This is also a necessary counter to some of the ingrained traditional requirements and “guidance values” that remain prevalent in GxP documents and inspectors’ minds.
The review aims to consider how timely use could be made of the CCS approach to bring together experience and forward thinking, in the diverse applications that hospital pharmacies face, and to help in selecting, implementing and maintaining robust practices benchmarked with experience elsewhere, rather than start afresh for every new project, nor prefer blind compliance to robust control measures.

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