Understanding and Implementing Annex 1
course description
EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.
It provides specific requirements for manufacturing sterile medicinal products, including principles for cleanroom and clean zone design, personnel experience/qualification, and monitoring of manufacturing environments.
Annex 1 provides comprehensive guidance on designing, constructing, and maintaining facilities and equipment used to manufacture medicinal products. It also includes guidelines on production processes, quality control, and documentation.
Participants will explore the similarities between this new guidance and the GMPs described in other regulatory strategies used for manufacturing sterile medicines.
course specifics:
- Participant Cap - 30
- Delivery - Face-to-face or Virtual
- Course Length - Six (6) hours
- Printed Materials - Sent to company or college prior to delivery for them to print and disseminate