Get your Aseptic Facility Ready for EU GMP Annex 1

WEBINAR

Abstract

The European Commission published a draft revision of Annex 1, on Manufacturing of Sterile Medicinal Products (1). One purpose of the revision was to introduce principles of Quality Risk Management (QRM) to allow the adoption of new technologies and innovative processes. The upcoming Annex 1 revision will include guidance specifically on designing a risk-based and effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles.

In line with the CCS, the selection of EM sampling sites as well as methods is crucial for the GMP manufacturing environment. Sampling locations & methods of sampling should not by itself generate cross contamination. The EM data should be reviewed routinely and assessed performing trend analysis; data tracking system & software’s are also being implemented respecting data integrity.

During the live event, the experts discussed:

• Points to consider for contamination control strategy (CCS)
• Setup of Microbiological Environmental Monitoring program and its application for sterile products manufacturing.
• Design of hardware and consumables to perfectly fit into the environment of use