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EudraLex GMP guidelines, Annex 1

August 2022 revision

Annex 1 of EudraLex, Volume 4, GMP guidelines update

Annex 1 of the EudraLex, Volume 4, Good Manufacturing Practice (GMP) guidelines for medicinal products for human and veterinary use provides guidance for the manufacture of sterile medicinal products.

Innovations in regulatory and manufacturing environments, science and technology, have made it necessary to revise Annex 1. These updated guidelines will come into operation on 25th August 2023 (25th August 2024 for point 8.123 on lyophilizer sterilization) and will affect sterile drugs made in the European Union, as well as imported products.

Why has EU GMP Annex 1 has been revised?

The revision of the previous document (in effect since 2008) was mainly necessary to:

  • Incorporate the principles of quality risk management (QRM) into sterile drug manufacturing (according to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Q9 and Q10 guidelines)
  • Reinforce that manufacturers of medicinal products shall use modern production systems, based on the availability of state-of-the-art technologies
  • Introduce specific requirements for single use systems (SUS)
  • Harmonize sterile drug manufacturing principles with World Health Organization (WHO) and Pharmaceutical Inspection Cooperation Scheme (PIC/S) standards for sterile drug manufacturing

How Eurotherm helps compliance with the revised requirements

Several new requirements and recommendations are included in the updated version of Annex 1, and they can represent compliance challenges for many sterile drugs manufacturers. To support life science companies’ compliance with the revised document, Eurotherm focuses priority on the following topics:

Environmental Monitoring Systems
Eurotherm EMS Digital Engineered Solution can monitor temperature, humidity, pressure, particle counters, and contamination according to the new guidance. Our EMS DESs leverage strategic partnerships to deliver pioneering solutions.

Indicator of air pressure differences
According to Annex 1 air pressure differences should be continuously monitored and recorded. Eurotherm provides a simple solution, embedding Eurotherm Store and Forward technology, to help reduce the risk of data loss, avoiding gaps in the historian database, and to support the Data Integrity ALCOA+ principles. Warnings and alarms are delivered to on-premise or cloud-based repositories and mobile devices.

Sterilization by heat
As a leading global supplier of data management technology, Eurotherm designed a solution to help OEMs and end users to meet point 8.50 of Annex 1, by providing off-the-shelf monitoring solutions and redundant control solutions that are cost-effective, easy to qualify and sustain good manufacturing processes.

Need to identify regulations applying to your environmental monitoring system?

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