The revised EU GMP Annex 1 for sterile medicinal products was published in August 2022, replacing the 2020 draft and the 2008 version.
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Drug developers had until 25 August 2023 to put the new standards into operation, giving them one year to implement the changes.
These updated requirements were designed to better regulate the manufacturing and importation of sterile drugs in and into the European Union (EU). Pharmaceutical manufacturing is performed in strictly controlled environments to reduce contamination, and the changes announced in Annex 1 focus more on strategic control than on quality measurement.
The revised Annex 1 is also more closely aligned with the manufacturing principles set out by the Pharmaceutical Inspection Cooperation Scheme (PIC/S), the World Health Organization (WHO), and the US Food and Drug Administration (FDA).
The revision fully rewrites the existing Annex 1 from 2008, almost quadrupling its length and dividing the document into 10 clearly defined sections.
One key change is the separation and differentiation of the Certification (Section 4) and Monitoring (Section 9) sections. This allows for expanded guidance and distinction between the design and qualification of premises and ongoing routine monitoring.
A new section discusses the concept of a Contamination Control Strategy (CCS), shifting to a paradigm that incorporates CCS as a holistic approach and relates it to how each contamination aspect interacts with the wider facility.
Another new section identifies and discusses Quality Risk Management (QRM) as a core principle for defining operations, processes, and limits, and links QRM to CCS to better balance process against risk.
The new revision also outlines regulations for Environmental Monitoring. These are essentially the same, with a small number of improved descriptions designed to better align these requirements with QRM principles.
This information has been sourced, reviewed, and adapted from materials provided by Particle Measuring Systems.
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