ISPE CEUs: 1.3
Type: Classroom Training Course
This course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities. The Guide provides valuable information on design, while the USFDA's Guidance helps professionals understand the regulatory context and expectations for sterile drug manufacturing.
Immediately apply the course learning objectives using the complimentary copy of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Second Edition)
Using the referenced documents, this course will cover regulatory philosophy, aseptic process and equipment considerations, aseptic clean room design and operation, differential pressure requirements, airlocks, basic utility systems, European HVAC considerations, and a brief introduction to barrier isolation technology. (Note: parts of Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice that do not focus on facilities and equipment will not be discussed in detail.)
In addition, the course will include an exercise in the layout of an aseptic filling facility. In many cases, when a new facility is required within an existing or new building, the designer will begin by sketching a floor plan. This exercise will demonstrate how to use process flow diagrams and an accommodation schedule to thoroughly define facility requirements before advancing to the floor plan layout stage.
NOTE: Participants interested in commissioning and qualification should attend the Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification training course.
This training course is of particular interest to existing and future members of the ISPE Sterile Products Processing (COP).