Annex 01 – Manufacture of Sterile Medicinal Products – 2020
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.