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Storage Delivery and Qualification of Pharmaceutical Waters (T23)

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

Date

Location

Country

Instructor(s)

10 - 11 Sep 2014 Philadelphia, PA USA Mr. Gary V. Zoccolante
19 - 20 Nov 2014 Raleigh, NC USA Mr. Gary V. Zoccolante

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.

Description

This 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.

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.

Water Systems Cover 

Immediately apply the course learning objectives with the complimentary copies of the Water and Steam Systems Baseline® Guide (Second Edition) and the Good Practice Guide: C&Q of Water and Steam Systems (Second Edition).

Course Modules

  • Regulatory Overview
  • Planning & Programming
  • Storage & Distribution Sanitization and Microbial Control
  • Storage & Distribution Configurations
  • Storage and Distribution Design
  • Laboratory Water Storage and Distribution
  • Commissioning, Qualification & Validation
  • Rouge, Stainless Steel and Passivation
  • Appendix: Traditional, Risk and Science-Based Water System Commissioning and Qualification

Take Back to Your Job

  • Differentiate regulatory requirements from regulatory myths relative to water distribution and storage systems
  • Identify the alternative designs for storage and distribution systems and the advantages and disadvantages of each
  • Analyze the principles behind water system testing and qualification
  • Understand the impact of water quality requirements (compendial and non-compendial) on water system operations
  • Define the basic requirements for water distribution system component and overall system construction
  • Integrate commissioning and validation activities
  • Streamline the validation process
  • The course will provide and understanding on the importance of C&Q (Verification) and how it fits into the Validation Life Cycle and the Project Lifecycle
  • Explain and demonstrate an example of a science and risk based risk management process for water and steam systems and what are typical system boundaries and critical aspects
  • Discuss Critical Aspects (CA) – CQAs and CPPs
  • Discuss business essential parameters – key business considerations for design, construction, commissioning, and qualification. Some of these relate to non-product quality items like HSE considerations, IT, or other “commissioning only” project scope items.
  • Provide identification of and discussion on project scope activities included in the qualification of water and steam systems in the context of full project delivery
  • Provide information on the URs, FS, and how a QbD approach may be implemented.
  • Ultimately, provide an alternative “science and risk-based” method that can be applied to the qualification of GMP water and steam systems

Attendance Recommended For

  • Professionals new to pharmaceutical water distribution systems.
  • Those with significant engineering expertise from another industry who need to learn about pharmaceutical water distribution systems
  • Those with significant pharmaceutical industry experience in a non-water system capacity who now have water system engineering and/or maintenance responsibilities and want to gain a fundamental understanding of the requirements for designing, building, operating, testing, and maintaining these systems
  • Quality assurance and quality control specialists, manufacturing supervisors, technical support personnel, validation personnel, and all levels of management who want to gain a fundamental understanding of pharmaceutical water systems
  • Commissioning and validation engineers with experience in the field but who may be unfamiliar with pharmaceutical water

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).

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.

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