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The EU Annex 1 in the final version, 2022
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 was 25 August 2023.
Regarding section 8.123 on freeze-drying and product transfer, the deadline for entry into force was two years from publication and became mandatory on 25 August 2024.
The Annex 1 is included in the GMP Compliance Adviser (see below).
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An online publication that covers all aspects of Good Manufacturing Practice (GMP) in one...
€585.00 net
625.95 - 7.00
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An online publication that covers all aspects of Good Manufacturing Practice (GMP) in one...
€3,480.00 net
3723.6 - 7.00
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The EU GMP Guideline Annex 1 "Manufacture of sterile medicinal products" in a comparison of the...
€99.00 net
105.93 - 7.00