Good Engineering Practice in Support of Science and Risk-Based Commissioning and Qualification - Applying the ISPE Good Practice Guide, Second Edition: Good Engineering Practice (T75)
Overview
The purpose of this workshop-driven course is to define Good Engineering Practice (GEP) that supports and enables the design, delivery, and operation of engineered systems in regulated industry. In the context of pharmaceutical engineering and GxP guidance, GEP is frequently referred to as a prerequisite to compliance activities and may be loosely defined in documents. GEP is often used to describe an engineering management system that is expected in a regulated company, but which is not mandated by GxP regulations. For example, effective project progress monitoring and control is not a regulatory issue but is necessary for the efficient operation of a company and is part of GEP.
This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. GEP provides a foundation required across the pharmaceutical industry that other areas, such as GxP build upon. This course, based on ISPE Good Practice Guide: Good Engineering Practice (Second Edition) also defines and clarifies GEP as an enabling process for Quality Risk Management (QRM)-based integrated Commissioning and Qualification (C&Q) as described in ISPE Baseline Guide: Volume 5 – Commissioning and Qualification (Second Edition).
NOTE: It is strongly recommended that participants be familiar with basic concepts of Good Engineering Practice and commissioning and qualification prior to attending this course.
What You Will Learn
- Understand the breadth and coverage of GEP as a lifecycle process
- Define the core concepts, key practices, and enablers of GEP
- Core Concepts: Risk Management, Cost Management, Organization and Control, Innovation and Continual Improvement
- Key Practices: System Lifecycle Processes, Project Engineering Management Practices, System Design Practices, System Delivery Practices, Operational Support Practices, Ancillary Support Practices
- Enablers: Engineering Quality Process (EQP)
- Apply Quality Risk Management (QRM) principles to GEP
- Understand how GEP supports and is an enabler for the QRM-based integrated C&Q process
Resources and Activities
- Pre-Course Work Materials
- This course was developed with input by members of the ISPE Commissioning and Qualification COP and the Good Practice Guide: Good Engineering Practice 2nd Edition Guide Draft Team.
- Interactive Exercises
- Learning Assessments
- Good Practice Guide: Good Engineering Practice 2nd Edition
Course Modules
- Introduction and Overview of GEP Good Practice Guide
- GEP Core Concept: Risk Management
- Workshop: Risk Management
- GEP Core Concept: Cost Management
- Workshop: Cost Management
- GEP Core Concept: Organization and Control
- Workshop: Organization and Control
- GEP Core Concept: Innovation and Continual Improvement
- Workshop: Innovation and Continual Improvement
- GEP System Lifecycle Processes: Change, Issue, and Document Management
- Workshop: Engineering Change Management
- GEP Project Engineering Management Practices
- Workshop: Project Engineering Management
- GEP System Design Practices
- Workshop: System Boundary Definition
- Workshop: Design Development/Design Review
- GEP System Delivery Practices
- Workshop: System Delivery Practices
- GEP Operational Support Practices
- Workshop: Operational Support Practices
- GEP Ancillary Support Practices
- Workshop: Ancillary Support Practices
- Overview of GEP in Support of QRM-Based Commissioning and Qualification
- GEP Enabler: Engineering Quality Process
- Workshop: EQP Deliverables
- Wrap-Up and Conclusion
Who Should Attend
Subject Matter Experts involved in the design, delivery, and lifecycle management of engineered systems in the pharmaceutical and other regulated industries:
- Project Engineers
- Process Engineers
- Other Engineers, Facilities, and Maintenance Personnel
- Engineering Services Providers
- Equipment/System Vendors
Other stakeholders involved with such engineered systems, such as:
- Business
- Manufacturing/Operations
- Validation
- Quality
- Commissioning, Qualification, and Validation (CQV) Services Providers
Additional Course Details
The Role of GEP in Support of QRM-Based Commissioning and Qualification
Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E2500-20 as defined in ISPE Baseline Guide, Volume 5, Commissioning and Qualification (Second Edition) ensures GMP facilities and equipment are "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. This course defines the role of Good Engineering Practices, applied throughout the system lifecycle, to support and enable this approach.
Learning Objectives:
- Understand the breadth and scope of GEP within regulated industry.
- Understand the role of GEP in managing risk, costs, and project and operational controls.
- Understand the role of GEP in driving innovation and continual improvement in manufacturing processes and the facilities and systems that support them.
- Understand the 2019 ISPE Baseline® Guide, Volume 5: Commissioning and Qualification (Second Edition) and how it links to concepts in the 2021 ISPE Good Practice Guide: Good Engineering Practice (Second Edition).
- Understand the role of GEP in management of engineering projects, including project requirements and scope definition, project infrastructure, project planning and organization, project value analysis, and project monitoring and control.
- Understand the role of GEP in management of system design, including system boundary definition, system requirements definition, design development, design review, and design qualification.
- Discuss the information necessary to develop Requirements Documents that will support a science and risk-based approach to focus the qualification effort. Given the necessary information and a list of requirements, identify those that are necessary for product quality and those that are business/safety related.
- Apply risk management throughout the design and verification phases. Explain the link between risk assessments, design review, and quality risk management.
- Understand the role of GEP in management of system delivery, including vendor management, construction, commissioning, and turnover.
- Understand the role of GEP to implement verification through the C&Q process (FAT, SAT, IV, FV, PT)
- Understand and examine the development of a C&Q/Verification Strategy that incorporates use of vendor testing, construction quality assurance, site acceptance testing, installation checks, and functional testing.
- Understand the role of GEP in management of system operational support, including asset management, calibration, maintenance, and decommissioning.
- Understand the role of GEP in ancillary support of systems, including engineering storage, waste management, and facility and equipment repurposing.
- Understand the roles and responsibilities of Engineering and Quality throughout the system lifecycle, including design, delivery, verification, release, operation, and retirement.
- Understand how the Engineering Quality Process defines the linkages and boundaries between Engineering/GEP and Quality/GMP.
Community of Practice (COP)
This training course is of particular interest to existing and future members of the following ISPE Commissioning and Qualification Communities of Practice (COP).