GAMP® 5: Insights from the 2nd Edition Update – The Key to Successful Validation and CSV

After 14 years, ISPE released the 2nd edition of the GAMP® 5 guide “A Risk-Based Approach to Compliant GxP Computerized Systems” in August 2022. While the core principles from the 1st edition remain valid, this update adds fresh insights to navigate the ever-evolving landscape of information technology within GxP environments. Additionally, it also expands on existing topics.

The principles outlined in GAMP® 5’s 2nd edition offer cutting-edge guidance for achieving compliant GxP computerized systems that are not only suitable for their intended purpose but also meet all relevant regulatory requirements. Properly applying GAMP’s knowledge ensures that compliance is achieved while adding value to your company by focusing on critical aspects related to patient safety, product quality, and data integrity. This approach isn’t just about achieving compliance but also sustaining it throughout the system’s lifecycle.

One noteworthy update addresses how to scale and define the validation approach. It emphasizes understanding business processes and the system/product, utilizing historical and supplier knowledge optimally. Validation efforts, required lifecycle deliverables, and controls should align with risk levels, system size, complexity, novelty, and supplier assessments. The focus remains on elements that impact patient safety, product quality, and data integrity. Critical thinking plays a pivotal role in this approach, ensuring well-informed and rationalized decisions at key points in the system’s lifecycle. It highlights that not all systems require the same approach, avoiding rigidly enforced activities that may not add value.

Software development practices have evolved, with larger projects adopting non-linear approaches like Agile for discovery, learning, and continuous improvement. The 2nd edition details efficient ways to address specification and verification when using iterative and incremental methods, making them suitable for GxP environments. Linear approaches are still appropriate for projects with predefined requirements.

The increased use of Cloud services has brought service providers into focus. Leveraging supplier knowledge, experience, and documentation is encouraged and should align with supplier assessments.

Automation and software tools have gained prominence for improved control and lower risk levels. They facilitate value-added testing while reducing cumbersome documentation. Different testing methods can optimally verify the system’s fitness for intended use. Systems and tools also reduce the need for traditional paper-based documentation, increasing efficiency and traceability.

Additionally, the 2nd edition addresses emerging technologies such as Blockchain, Artificial Intelligence, and Machine Learning within GxP applications. It aligns more closely with IT Infrastructure Library (ITIL) practices.

Looking for Expert Validation Services?

At Farma Consulting & Partners, we offer validation services in compliance with the latest regulations, including the GAMP 2nd edition. For assistance in defining validation approaches, implementing lifecycle deliverables, and other validation and quality services, contact us today!

About the Author:

Tom Van Gompel, Lead Validation at FC&P, brings diverse experience in validation activities, particularly equipment, process, and computerized system validation. With a strong background in QA and QC activities, Tom can support you in developing, optimizing, and digitizing your quality processes.


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