The systems that generate and distribute pharmaceutical water and steam are subject to commissioning and qualification (C&Q) and/or verification to ensure that they will consistently deliver water and steam that meets regulatory, country, and company specifications. Critical utility professionals in the life science industries have relied on the ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems to help them manage the C&Q of pharmaceutical GMP water and steam systems since the first edition was published in 2008.
The recently published third edition builds upon the risk-based management information introduced in the second edition. It also incorporates changes in C&Q approaches developed and instituted over the past 10 years. It contains chapters on process analytical technology (PAT) and rapid microbial methods, appendices covering process water, pure steam, process steam, typical specifications, and change management, and a sample turnover package. “Risk-based management has changed dramatically over the past 13 years since the second edition of the Guide was published,” said Guide Co-Lead Nissan Cohen, Owner, Biopharmaceutical Water Doc. “Because of these changes, it was imperative that we update the Guide.”
“The third edition provides a backbone and a template that can be used to enhance IQ, OQ (installation qualification, operational qualification) function and help users to develop the qualifications in the most critical and quickest manner to bring systems or a piece of equipment into a production environment,” said Cohen. “The Guide itself is excellent, but the annexes to the Guide are extremely important because they give you samples of ideas and templates that could be used for specific scenarios such as sampling for microbials in order to determine whether the system is performing properly or not and use of online instrumentation in order to augment or replace laboratory instrumentation and testing.”
The ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems:
- Provides understanding of the importance of C&Q and how it fits into both a validation and a project life cycle
- Explains and demonstrates an example of a science and risk-based risk management process for water and steam systems and typical system boundaries and critical aspects
- Discusses critical quality attributes, critical process parameters, critical aspects, and critical design elements (CQAs, CPPs, CAs, and CDEs)
- Discusses business essential parameters—key business considerations for design, construction, commissioning, and qualification; some of these relate to non-product quality items like health, safety, environmental considerations, information technology, or other “commissioning only” project scope items
- Provides identification and discussion of project scope activities included in the qualification of water and steam systems in the context of full project delivery
- Provides information on the user requirement specifications (URS), functional specification for automation, and how a science and risk-based quality by design (QbD) approach may be implemented
- Provides a robust science and risk-based method that can be applied to the qualification of GMP water and steam systems
“As companies move to the use of more online or digital instrumentation, the quality of the water, the process, and the overall execution of the system will improve,” said Cohen. “It will allow companies to have better information and more knowledge using PAT. The more process knowledge you have, the better off your system is, the higher the quality of the system, the less breakdowns, and the fewer number of upsets and excursions that can happen in a water system.”
The ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems can be used as a standalone document as well as in conjunction with the ISPE Baseline® Guide, Volume 4 – Water and Steam Systems (Third Edition), the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition), and ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition).
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