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GMP Sterile Pharmaceutical Manufacturing Facility Training Course

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Sterile Product Manufacturing Facilities: Applying the ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation (T12) - Updated!

Level: Intermediate
ISPE CEUs: 1.3
Type: Classroom Training Course

Using the referenced documents, this course will cover regulatory philosophy, aseptic process and equipment considerations, aseptic cleanroom design and operation, differential pressure requirements, airlocks, air filtration, HVAC design 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.

Course Modules

  • Introduction to the Baseline Guide
  • Concepts and Regulatory Philosophy
  • Process and Equipment Considerations
  • Architecture and Layout
  • Environmental Control Requirements
  • HVAC Systems
  • Control & Instrumentation
  • Commissioning & Qualification
  • Barrier-Isolator Technology
  • Exercises
  • Supplemental Materials

Immediately apply the course learning objectives using the complimentary copy of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) 

 

 

Take Back to Your Job

  • Understand the regulatory impact on design, construction, and the regulatory context and expectations for sterile drug manufacturing including the use of RABS and isolator systems
  • Identify sources of contamination in aseptic operations
  • Explain methods used for contamination control
  • Describe the major requirements for design, renovation, and operation of a sterile manufacturing facility
  • Discuss the fundamentals of aseptic cleanroom design
  • Understand the importance of monitoring critical parameters: temperature, humidity, air velocity, differential pressure, airflow patterns, non-viable particle counts, and microbial counts
  • Design a systematic process for aseptic facility layout
  • Apply ISO 14644-1:2015, Clean Rooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness to pharmaceutical manufacturing facilities, and the relationship with the GMP requirements.
  • Distinguish between the US FDA’s 2004 Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice and the equivalent requirements expressed in Annex 1 of the EU and PIC/S GMPs.

Attendance Suggested For

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Sterile Products Processing (COP).

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This course is not currently scheduled, but may be offered at your company site.

Please contact ISPE for more information.