Description

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.