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GAMP® 5 Second Edition is Here!

Sion Wyn
Heather D. Watson
Chris Clark
GAMP® 5 Second Edition is Here!

GAMP® 5 Second Edition is here! Since its publication, GAMP® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance, and it was time to update our guidance to reflect technological progress.

GAMP 5 Guide 2nd EditionAs a society and as an industry we have learned some important lessons from the global COVID-19 pandemic, not least that innovation and technological advance are essential to safeguarding patient safety and public health, and that industry and regulatory flexibility is vital in meeting these key objectives.

One of the reasons GAMP® guidance has always been successful, is that it has reflected the current good IT and software engineering practice, based on input from experienced IT, automation and software practitioners. We must always ensure that GAMP® guidance is well-aligned with current good practice. We cannot provide guidance based on technical concepts, approaches, or techniques that are in some cases decades old, even if they do sometimes remain enshrined in regulatory guidance or company policies and procedures. Surely, we wouldn’t even consider applying old-fashioned, superseded and outdated medical science or medical practices, so why should it be different for IT and software?

We do, however, still see too many examples of ineffective and inefficient practices for reasons including organizational inertia, lack of experience and training, compliance-driven tick-box approaches, and a misguided fear of perceived regulatory inflexibility.

GAMP® 5 Second Edition prioritizes patient safety and product quality over compliance and encourages the application of critical thinking. The Second Edition strongly supports the FDA CDER (Center for Drug Evaluation and Research) vision of a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight, where the vision requires moving beyond simply meeting minimum CGMP standards and towards robust quality management systems.1

The overall GAMP® 5 framework, key concepts, and ICH Q9 aligned Quality Risk Management approach remain unchanged from the First Edition. The technical content of the Guide has been updated to reflect the increased importance of IT service providers including cloud service providers, evolving approaches to software development including incremental and iterative models and methods, and increased use of software tools and automation. Second Edition builds upon the work of the ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management.2

Guidance on the application of new and developing technological areas such as Artificial Intelligence and Machine Learning (AI/ML), blockchain has been included. The concepts of computerized systems assurance (CSA) related to US FDA CDRH (Center for Devices and Radiological Health) Case for Quality program are also explored and applied.

GAMP® 5 Second Edition seeks to not only to achieve minimum compliance expectations, but also to apply good IT practices, robust Quality Risk Management approaches, and excellence in software engineering, to achieve better product quality and safety, for the benefit of the patient and the public.

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