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EC: Long-awaited EU Annex 1 on Sterile Manufacturing Published

EC: Long-awaited EU Annex 1 on Sterile Manufacturing Published

The long-awaited final version of the new EU Annex 1 "Manufacture of Sterile Medicinal Products" was published on 25 August 2022. The deadline for entry into force is 25 August 2023. Regarding section 8.123 on freeze-drying and product transfer, the deadline for entry into force is two years from now and will thus become mandatory on 25 August 2024:

    8.123 Lyophilizers and associated product transfer and loading/unloading areas should be designed to minimize operator intervention as far as possible. The frequency of lyophilizer sterilisation should be determined based on the design and risks related to system contamination during use. Lyophilizers that are manually loaded or unloaded with no barrier technology separation should be sterilised before each load. For lyophilizers loaded and unloaded by automated systems or protected by closed barrier systems, the frequency of sterilisation should be justified and documented as part of the CCS.

Following two draft documents published in 2017 and 2020, over 6000 comments and much speculation about the final publication date, it is finally here: the new Annex 1 of the EU GMP Guide on Sterile Manufacturing.
With 58 pages, the document has grown in size by another six pages, but its basic structure into eleven areas has remained the same. Among these, the topics of isolators and RABS (4.18) and the section on "Form-Fill-Seal (FFS)" (8.96) are mainly to be mentioned. Isolators and RABS have been subdivided into independent sections and further deepened, which also applies to the topic of FFS, which has been significantly expanded.

Stay in the loop:
We will publish more detailed and comprehensive information on the final Annex 1 in our newsletter LOGFILE as of next week.


EC: Annex 1 on Manufacture of Sterile Medicinal Products