A STRENGTHENED FOUNDATION: ISPE C&Q GUIDANCE AND ADDENDUM
The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) continues to serve as the premier reference for implementing science- and risk‑based C&Q programs. Its principles—such as quality risk management (QRM), identification of critical aspects (CAs) and critical design elements (CDEs), and integration with quality by design (QbD) and life cycle verification—have become benchmarks across industry.
To help organizations implement these concepts more effectively, the ISPE C&Q Community of Practice (CoP) will soon release a new C&Q Implementation Addendum. The addendum formalizes a pragmatic, modernized delivery model built around product and process knowledge (PPK) and the manufacturing process control strategy (MPCS). It aligns directly with ICH Q9(R1), ICH Q10, and ASTM E2500‑25, and it promotes early design alignment, robust traceability, integrated commissioning, and risk‑focused verification.
Across the industry, teams adopting this methodology report improved project speed, stronger regulatory alignment, reduced documentation burden, and enhanced collaboration between engineering, quality, and manufacturing.
To learn more about the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition)
For more details on the forthcoming addendum, read the article, “Driving the Future of Commissioning and Qualification: Inside ISPE’s New C&Q Implementation Addendum and Webinar Series” by Nathan Temple and Stephanie White in this issue.
To help organizations implement these concepts more effectively, the ISPE C&Q Community of Practice (CoP) will soon release a new C&Q Implementation Addendum. The addendum formalizes a pragmatic, modernized delivery model built around product and process knowledge (PPK) and the manufacturing process control strategy (MPCS).
C&Q THOUGHT LEADERSHIP: CONNECTING GUIDANCE AND PRACTICE TO ADVANCE MEMBER EXPERTISE
ISPE’s training courses have remained a central pillar of member engagement, with offerings designed to support professionals at all levels.
- Science and Risk-Based Commissioning and Qualification - Applying the ISPE Baseline® Guide, Volume 5, Second Edition: Commissioning and Qualification (T40): This training course uses interactive instruction in applying the Second Edition Baseline® Guide, including QRM‑based process flows, system verification, and quality system integration.
- 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): This workshop-driven course focuses on how GEP underpins risk‑based C&Q and supports GxP expectations.
- Risk-Based Verification of Facilities, Systems and Equipment Workshop (T48): This course provides learners with sustainable, risk‑based C&Q programs within facility and quality management systems.
These courses continue to strengthen the skill base of ISPE members around the world.
Learn more about Commissioning and Qualification training.
ISPE’S NEW C&Q WEBINAR SERIES: A GLOBAL LEARNING COMMUNITY
To further support industry transformation, the ISPE C&Q CoP launched a complimentary nine‑part webinar series that has rapidly become a global event, drawing participants from every region and fostering new cross‑industry, cross‑continental learning networks.
The webinar series includes:
- Foundations of QRM‑Based C&Q
- Transitioning Programs and Audit Defense
- Good Engineering Practice (GEP) in Modern C&Q
- Engineering Change Management (ECM)
- User Requirements Specifications (URS)
- System Boundaries and Classification
- Commissioning in an Integrated C&Q Model
- Qualification, Acceptance, and Release
- Integrated C&Q Across the Lifecycle
These sessions mirror the natural progression of modern C&Q, helping participants build capability step by step while engaging directly with peers and experts around the world. For more details, read the article “Driving the Future of Commissioning and Qualification: Inside ISPE’s New C&Q Implementation Addendum and Webinar Series” by Nathan Temple and Stephanie White in this issue.
ISPE members receive complimentary access to this webinar series and its presentations.
A GROWING, CONNECTED C&Q COMMUNITY
What emerges from ISPE’s combined efforts—Guidance Documents, training courses, and webinars—is a unified, energized C&Q CoP dedicated to strengthening science- and risk‑based C&Q practices. Members are sharing lessons learned, aligning methodologies, and elevating the discipline of C&Q worldwide. As the industry continues to accelerate innovation, ISPE’s C&Q CoP ensures that speed, safety, and quality remain mutually reinforcing pillars of modern C&Q.
To join the C&Q CoP and learn more about the benefits of joining any CoP.
