ISPE Hands-on Training: Impact of the Annex 1 Revisions

Driven primarily by biopharmaceuticals but also important in small molecule drug product manufacturing and APIs, aseptic processing is undergoing a technology transformation driven by the new EC GMP Guide Annex 1. Companies globally that deliver medicinal products to Europe must comply with the new regulatory requirements. The Annex 1 revisions impact not only product manufacturers, but also engineering firms and equipment suppliers when providing services or equipment in either renovated or new production facilities.

The requirements of the new Annex 1 must be implemented in the production of sterile and aseptic processes. The industry is currently within the 1-year implementation period, and after the 24th of August 2023 manufacturers must fulfill the new Annex 1 requirements.

ISPE is offering a training program centered on how to implement these new requirements with a best practices approach. This training encompasses the two main pillars of the Annex 1: Quality Risk Management (QRM) and Contamination Control Strategy. In addition, this program covers aseptic production operations from compounding to fill & finish and freeze drying. The program consists of 2 full days at our industrial platform the Europe Aseptic and Sterile Environment (EASE) in Strasbourg, France, March 22 and 23, 2023. Our facilities provide Hands-on opportunities to interact with facilities, equipment, and staff members in an industrial environment specifically built for training pharmaceutical industry workers.

For the 2-day sessions, ISPE will run four courses in parallel in English where the specific impacts of Annex 1 will be discussed.

• Advanced Therapy Medicinal Products (ATMPs) Manufacturing
• Commissioning & Qualification (C&Q)
• Heating, Ventilation, and Air Conditioning (HVAC)
• Pharmaceutical Water Systems

Find all the information about the proposed training courses, and register now by clicking here!