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30th January 2023  Content supplied by: bioMérieux (Industry)

Guidelines for the Manufacturing of Sterile Medicinal Products

Did you know? The Directorate for Health and Food Safety of the European Commission published the final version of Annex 1 Manufacture of Sterile Medicinal Products of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.

The EU GMP Annex 1 is one of the main documents governing the manufacturing, control, and release of sterile pharmaceutical products, both terminally sterilized and aseptically filled drug products.

This Annex 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.

Want to discover more about:

  • The Annex 1 main documents
  • The Contamination Control Strategy details
  • Quality Risk Management principles
  • Invigorated use of rapid alternative and automated microbiological methods
  • Identification strategy for environment contamination
  • New ways of bacterial endotoxin detection

Read our GMP Annex 1 Digest, by Felix Montero Julian, Scientific Director Pharma Quality Control Business at bioMérieux, or use the Request Information button below to contact the supplier.

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Date Published: 30th January 2023

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