Containment of High Potent APIs in API, OSD and Aseptic Processing With a focus on NEW EU Requirements

The EU has new GMP regulations that address cross contamination. The new requirements require interpretation by Industry as well as Regulators regarding the use of dedicated and self-contained facilities for additional products. The updates to the EU GMPs in regards to managing the risk of cross contamination are a major improvement to the existing uncertainty on the topic. These updates also require that the manufacturing companies truly understand the products they are handling, their facility limitations, the processes and equipment used to make quality medicines in a cost effective manner that will be safe for all patients.

In the above context Containment and Decontamination are critical processes involved in the manufacture of Pharmaceutical products both the production of Active Pharmaceutical Ingredients and the Finished Dosage Forms containing the active drugs. This 1-day training will focus on Containment Fundamentals, Risk Assessment, Life Cycle, Process Solutions, Different Containment Systems, Secondary Containment, Cleaning, and Waste Handling to Operator Training

Programme Overview

• 9:00 – 10:00 Introduction of the new ISPE DACH Containment Manual
• 10:00 – 10:30 New EMA Requirements on shared facilities
• 10:30 – 11:00 Break
• 11:00 – 11:30 Risk Assessment and Containment Life Cycle
• 11:30 – 12:30 Different Containment Technologies and their applications
• 12:30 – 13:30 Lunch
• 13:30 – 14:00 Requirements for highly potent aseptic products
• 14:00 – 14:45 Aseptic Processing
• 14:45 – 15:30 Work Hygienic Validation for Aseptic Processing
• 15:30 – 16:00 Break
• 16:00 – 17:00 Discussion with Question and answer session
• 17:00 End of the training