While it officially applies to the manufacture of sterile medicinal products in the European Union, the revised EU Good Manufacturing Practice (GMP) Annex 1 effectively reset the benchmark for quality standards across the globe on 25 August 2023.
At this point, entire supply chains entered a new era defined by a raft of updated rules, all of which are ultimately focused on enhancing levels of public health protection. Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety.
The holistic approach to CCS required by Annex 1 encapsulates primary packaging components and the wider supply chain vital to compliance. Components clearly have a key influence on the sterile drug product quality, through their role in reducing the potential for microbial ingress and particulate matter, demanding that they are manufactured in environments where sterility is controlled and assured.
This carries far-ranging implications for pharmaceutical companies, who must be able to depend on manufacturing partners. It is their deep understanding of the updated Annex 1 regulations together with systems that are geared towards limiting contamination as part of an ongoing process of continual improvement. And while it is essential for these contamination risks to be approached at an operational, equipment and process level, at the same time they must also be considered from a behavioural perspective given the potential for the sterility of cleanroom environments to be compromised by human activity. Equipping staff with a ‘contamination-control mindset’ through continual education and communication is therefore fundamental if quality measures are to be upheld and enhanced over time. In this article, we look at how these elements can be integrated into a joined-up approach that provides pharmaceutical companies with the assurance of end-to-end compliance with Annex 1.
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