Education Sessions

ASTM E2500, the Original C&Q Baseline Guide, and the New Science and Riskbased Approach for Specification, Design, Installation, and Verification for Facilities, Utilities and Equipment Baseline® Guide – Overview and Managing the Transition (703)

28 October 08.15-11.30 Track: Efficient and Effective Compliance

ISPE CEUs: 0.2

agenda(PDF Current as of 26 August 2008)

The ASTM Standard defines at a very high level what is required under the new Verification Process to establish Pharmaceutical Facilities so that facilities are Fit For Use. The new Commissioning and Qualification Baseline® Guide in final development ("Volume 12 Science and Risk-Based Approach for the Specification, Design, and Verification of Facilities, Utilities and Equipment Systems") has begun the process of "how" to implement the verification process. The original Commissioning and Qualification Baseline Guide (Volume 5, Impact Assessment) continues to be an acceptable approach to qualification.

Receive an overview of different approaches to qualification and initial approaches and strategies being developed by the C&Q COP to assist industry in the transition from impact assessment to ICH Q9 risk-based approaches. A workshop at the end of session provides input and recommendations to the transition process. It will focus on the standard, Baseline Guides and Transition approach. Session 704 on Tuesday afternoon, 28 October, will present a series of case studies detailing transition approaches being implemented by owner companies. You may wish to attend both of these sessions for a fuller view of this topic.

How You Will Benefit

At the end of this session, participants will be able to:

  • Understand what is required by the ASTM E2500 standard
  • Describe the verification process
  • Describe the difference between the new and original C&Q Baseline Guides
  • Understand the risk-based approach and how it is a different approach

Technical Documents — www.ISPE.org/publications

Commissioning and Qualification Baseline® Guide

Who Should Attend

All multi-disciplined project teams which are responsible for demonstrating that manufacturing elements are Fit For Use (i.e. qualified) to produce pharmaceutical products meeting quality requirements. This includes engineering, quality, SMEs, R&D, operations, among others.

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