New document enters a three-month consultation period
The Directorate for Health and Food Safety of the European Commission has published a new draft for the revision of Annex 1 of the EU GMP Guide to Good Manufacturing Practice, the ECA Academy has reported.
Organisations and stakeholders can submit their comments to the revised document within the three-month consultation period.
The Annex 1 of the "Manufacturing of sterile medicinal products" was first published in 1971, and has been updated several times over the years. Amends have been around the classification table of cleanrooms to include guidelines on media simulation and biological stress monitoring, and the guidelines on vial sealing in 2010.
The current review dates back to 2017 when the first draft of a fundamental revision was published. It was intended to focus on structured guidance, incorporating contemporary principles such as quality risk management and consideration of new technologies and innovative processes.
The 2017 revision featured new sections for utilities and extended sections on topics such as production and specific technologies on the requirements of Aseptic Process Simulation (APS).
The current revision builds on more than 6,000 comments submitted to the European Medicines Agency.
The current document contains a large number of changes compared with the 2017 draft. It now comprises just over 50 pages divided into 11 sections:
The ECA Academy has announced a series of articles arranged by topic will be published on its website in due course.
Below is an excerpt of ECA's first analysis on the Premises and Qualification considered in the new draft revision.
In relation to the contamination control strategy (CCS), "it is also possible to build a bridge to the topic of insulators and RABS", concepts already present in Premises, and described as 'useful in ensuring the necessary conditions and minimisation of microbial contamination associated with direct human intervention", thus should be considered in a CCS.
The ECA notes that the topic of transfer of materials, equipment and other components is already taken into account in Premises with sub-sections 4.10 and 4.11, i.e. immediately before the section on airlocks.
The chapter concerning cleanroom qualification, reference is made to ISO 14644, yet with further focus on the measurement of particle sizes: "For cleanroom classification, the airborne particulates equal to or greater than 0.5 and 5 µm should be measured. For Grade A zone and Grade B at rest, classification should include measurement of particles equal to or greater than 0.5 µm; however, measurement using a second, larger particle size, e.g. 1 µm in accordance with ISO 14644 may be considered. This measurement should be performed both at rest and in operation."
The ECA notes that the current difference to ISO 14644, which only refers to one of the two sizes, is therefore still maintained.
The complete draft of Annex 1: Manufacture of Sterile Products is available on the European Commission website.