Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8 (R2), Q9, and Q10 and ASTM E2500. Topics covered include the principles and activities that constitute an efficient and acceptable approach to demonstrating facility and equipment fitness for use as required by major global regulatory authorities; improving the ability to meet documented process requirements; controlling risks within the manufacturing process; producing high quality products and consistent operation to meet product user requirements. Guidance on the transition of an organization’s approach to Commissioning and Qualification to one that incorporates a science and risk-based approach will be discussed.
This course was developed by members of the ISPE Commissioning and Qualification COP.
NOTE: It is strongly recommended that participants be familiar with basic concepts of commissioning and qualification prior to attending this course.
This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.
Implementing ASTM Standard for Verification
Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E2500-07 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 webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle.
At the conclusion of this Webinar, participants will be able to:
- Relate the ASTM Standard to GMP regulations and guidance documents
- Explain the regulatory foundation for the risk-based approach
- Understand the 2001 ISPE Baseline® Guide: Commissioning and Qualification and how it links to new concepts in the ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
- Differentiate qualification versus verification
- Differentiate between the new risk assessment approach versus the old one
- Understand how the new USFDA Process Validation links to ASTM E2500
- Understand the details on verification process flow
- Implement verification through the C&Q process (FAT, SAT, IV, FV, PT)
- Understand ways GEP can be used as a foundation for verification
- “Fitness-For-Use” Qualification of the Commercial Manufacturing Process
- User Requirements and Critical Aspects
- Core Concepts and Common Practices of a GEP Program
- Change Management
- Quality Risk Management (QRM)
- Design Reviews
- Specification and Design
- Verification Process
- Verification Workshop: Identification of GEP and GMP Deliverables
- Acceptance and Release (Qualification / Fitness-For-Use)
- Legacy Systems
- Composite Matrix for Requirement, Traceability, DQ and Testing
- Process Control & Automation Exercise
- Commissioning Plan and Strategies
Take Back to Your Job
- Explain the relationship between ICH Q9, ASTM E2500, ISPE Guide: Science and Risk-based Approach for the Delivery of Facilities, Systems, and Equipment and the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification.
- Discuss the information necessary to develop Requirements Documents that will support a science and risk based approach to qualification. 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 methodologies throughout design and verification phases. Explain the link between risk assessments, design review, and quality risk management.
- Understand and examine the development of a Verification Strategy that incorporates use of vendor testing, construction quality assurance, site acceptance testing, installation checks, and functional testing.
- Know what is involved in a system Acceptance and Release report given requirements, critical aspects, and verification test results in compliance with a verification strategy.
- Outline the use of GAMP® 5 principles in support of system delivery of a packaged system inclusive of mechanical and control system elements.
- Summarize US / EU / SFDA / and WHO regulatory requirements and expectations that may influence application of a science and risk based approach.
Attendance Suggested For
Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach.
Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory.
Community of Practice (COP)
This training course is of particular interest to existing and future members of the following ISPE Communities of Practice (COP):