Revision – Manufacture of Sterile Medicinal Products

On 25 August 2022 the European Commission published the revised guideline for GMP in the EudraLex Volume 4, annex 1.

This Annex 1 provides general guidance that should be used in the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying the principles of Quality Risk Management (QRM), to ensure that microbial, particulate and endotoxin/pyrogen contamination is prevented in the final product.

The deadline for coming into operation of Annex 1 is 25 August 2023, except for point 8.123 which is postponed until 25 August 2024.

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