ISPE CEUs: 1.3
Type: Classroom Training Course
Note: ISPE has two Pharmaceutical Water training courses that we deliver consecutively at our training events. You might also be interested in the Pharmaceutical Water Generation training course.
This classroom course will explore the essential concepts and principles of specification, design, commissioning/qualification of equipment and systems used to store and distribute water in pharmaceutical manufacturing. The course has been substantially updated to feature the guiding principles of the ISPE Baseline® Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control, laboratory water and rouging. The course material will cover methods for determining the appropriate distribution and storage strategy, including sanitization method, for various operating circumstances including an overview of optional distribution approaches and the advantages and disadvantages of each. Microbial control characteristics of the various distribution systems will be presented and compared. Point-of-use service and sample point design, materials of construction for distribution and storage systems, and instrument components will also be covered.
The course will include discussion of the upcoming European Pharmacopoeia regulatory change allowing alternative WFI production methods in addition to distillation. The change will align EP requirements closely with USP WFI production methods opening opportunities for membrane-based systems. The course will also include material from the new ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam and Process Gases and will review optimizing sampling plans to significantly reduce operational costs.
Traditional and risk-based approaches to pharmaceutical water system commissioning, verification, and qualification will be explored. System and component level impact assessments will be covered as well as identifying critical process parameters and critical quality attributes. The overall validation lifecycle for pharmaceutical water systems will be explored including, Operational, and Performance Qualifications. Sampling programs for qualification and normal operation will be discussed.
Additional content from the ISPE Good Practice Guide: C&Q of Water and Steam Systems (Second Edition) will include the risk assessment and risk mitigation process used during design and qualification is crucial to ensuring product quality, allowing system designers and operators to gain process understanding of those product/process quality attributes which affect water or steam quality. The course will use a risk assessment example to determine the critical aspects, definition of critical quality attributes/critical process parameters (CQA/CPP), and identification/appropriate execution of quality indicating verification activities applied throughout the Validation Life Cycle.
Examples of a science and risk-based risk-management process for water and steam systems and typical system boundaries and critical aspects examples are discussed. Information is provided on the URs, FS, and how a QbD approach including Critical Aspects (CA) – CQAs and CPPs may be implemented. The module provides an alternative “science and risk-based” method that can be applied to the qualification of GMP water and steam systems.
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Attendance Recommended For
Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE Critical Utilities Community of Practice (COP).