Annex 01 - Sterile Medicinal Products

manufacture sterile products

Annex 01 – Sterile Medicinal Products


This Annex covers the manufacture of medicinal products that are subject to special requirements to minimize risks of microbiological contamination.


Annex 01 – Sterile Medicinal Products

This interactive e-learning module on Annex 1 Sterile Medical Products introduces the specific GMP regulations for the manufacture of sterile medicines as found in EU and PIC/S Annex 1. This module is essential for personnel who work within the areas of?final fill and finish, environmental monitoring or sterility assurance.

The objectives of this training module are:

  • to understand the principles of sterile manufacturing
  • to understand the types of sterile manufacturing
  • to understand cleanroom classification and monitoring
  • to understand personnel requirements including garments
  • to understand the requirements for sterile manufacturing premises
  • to understand the importance of?sanitation
  • to understand different?sterilisation methods
  • to understand the importance of Quality Control

The regulations outlined in this module do not apply to non-sterile manufacturing facilities, however it is possible to draw valuable good practice guidance for non-sterile facilities.


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