What’s new about the revised Annex 1 guidelines and how to make sure your company is complying with the new standards for aseptic processing.

The new EU GMP Annex 1 guidelines came into effect last year, with total compliance expected by August 25, 2023 (except for point 8.213, which will be enforced from August 25, 2024 onwards). Compliance is required for all sterile medicinal products that are licensed in the EU regardless of the country of manufacture, so it is expected to be adopted internationally, with global harmonisation driven through the Pharmaceutical Inspection Co-operation Scheme (PIC/s), which adopted the new Annex verbatim. PIC/s drives mutual recognition of inspections across 54 participating health authorities, including the U.S. FDA.

The most significant change made to the revised guidelines is a stronger focus on risk management and the implementation of a contamination control strategy. It takes an improved risk-centric approach as opposed to the more regulatory mindset of the prior version. In the previous revision (2008), the only reference to risk is contained in Section 8: Cleanroom and clean air device monitoring. In contrast to this, there are references to risk in multiple sections throughout the revised draft. A more comprehensive Contamination Control Strategy (CCS) is outlined, which involves increased levels of environmental monitoring and is used to observe and control environmental contamination in cleanrooms. The latest revision acknowledges the advancements in sterile processing technology, such as restricted access barriers systems, isolators, robotic systems, and rapid microbial testing and monitoring systems, that can help minimise potential contamination in the surrounding environment.

Ardmac is the Gold Sponsor of our upcoming event, the ‘3rd Aseptic BioPharma Processing Summit’, where professionals and industry leaders will come together to discuss new manufacturing standards and many other innovations and challenges facing the aseptic processing industry. Ardmac is an international construction specialist that manufactures cleanrooms for all requirements, including mobile cleanrooms and modular cleanrooms. They provide cleanroom builds that comply with Annex 1 guidelines, such as their INTEGRA turnkey solution that guarantees control over particulate concentration, room pressurisation, temperature, humidity, and containment. Their CLEANSHIELD product range includes cleanroom build requirements such as HEPA filtration, flush doors and windows, and return airwalls.

MesaLabs is a Bronze Sponsor of our upcoming summit on aseptic processing and is a supplier of monitoring equipment and solutions that can be utilised to adhere to Annex 1 guidelines to ensure that microbial, particulate, and endotoxin/pyrogen contamination is prevented in the final product. They provide biological and chemical indicators that can be used to determine the sterilisation or disinfection cycle efficacy of a physical or chemical process, equipment and software for the monitoring of gases for contaminants, and help develop the right sterilisation cycles and routine monitoring procedures.

The new Annex 1 guidelines have more stringent regulations around risk management and contamination control strategy, but whether you’re upgrading your current cleanroom design or implementing CCS for the construction of new ones, there are many solution providers to make sure you are complying with the new standards for aseptic processing. To learn how to make your facility Annex 1 compliant, join Ardmac, MesaLabs, and many other solution providers and esteemed speakers from across the industry at the Innovatrix ‘3rd Aseptic BioPharma Processing Summit’ in Vienna, Austria, on October 29–30, 2024.

For more information, visit our website or email us at info@innovatrix.eu for the event agenda.