Validation and Qualification Approach Outlined in New Annex 1 Revision
The updated revision of Annex 1 further emphasizes how product and process should be appropriately designed, qualified, validated, and, where applicable, subjected to ongoing verification to be used in GMP sterile manufacturing, thus focusing closely on validation and qualification topics.
It is mandatory that the manufacturers understand processes and control their variability. Guidelines suggest managing in accordance with Quality Risk Management (QRM) principles throughout the whole process, including the design stage, to better improve flexibility and higher predictability of outcomes.
In this free webinar you’ll learn:
- why validation and qualification are important in the pharmaceutical process
- how to to implement the best practices required by GMPs
Who should attend:
All professionals involved in GMP sterile manufacturing, especially:
- Quality assurance
- Quality control
- Production and project managers