How Your GAMP Compliance May be Impacted by 2nd Edition Updates

In July 2022, the International Society for Pharmaceutical Engineering (ISPE) released the 2nd edition of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems. It’s the most significant update since the first edition of this good practice guide was launched in 2008, and is likely to address many questions Life Sciences organizations have asked around ensuring GAMP compliance in line with technology shifts.

There’s a lot to unpack among these changes, which is why we will be providing insight over the next few weeks as to how this updated edition of GAMP 5 is likely to impact your business. We’ll begin below with an overview of some of the most significant changes in the world’s most used guidance for pharmaceutical industry compliance and computer system validation.

What is GAMP 5?

GAMP 5 is regarded as the definitive industry guidance on GxP computerized system compliance and validation. Its objective is to assist Life Sciences companies in achieving patient safety, product quality, and data integrity while enabling room for innovation and technological advances. While GAMP compliance itself is not mandatory, it is referenced by regulators around the world.

While GAMP 5 updates have been infrequent, ISPE does release its GAMP Good Practice Guides (GPGs) on a regular basis. The most recent GPG, Enabling Innovation: Critical Thinking, Agile and IT Service Management was released in September 2021. Many aspects of the GPGs are reflected within the broader GAMP 5 document. For example, the Enabling Innovation GPG helps organizations align innovative, Agile pharmaceutical development can with GxP and GAMP 5 principles.

Background to the 2022 GAMP update

In 2017, experts within the GAMP Community of Practice began a formal review of GAMP 5 to ensure its guidance reflected broader changes happening in technology and pharmaceutical processes. In the 14 years since GAMP 5 was first published, Life Sciences organizations have increasingly moved to cloud solutions, a shift that has the potential to open organizations up to new risks. In addition, there have been significant advances in the use of artificial intelligence (AI) and machine learning (ML) solutions to automate processes, a trend not previously addressed by GAMP 5.

In addition to these technology changes, the GAMP 5 2nd edition accounts for process updates. It accommodates Agile methodologies and encourages critical thinking by knowledgeable and experienced experts in defining an appropriate approach for specific circumstances.

Although these changes will have an impact on some key components of how computerized systems ensure GAMP compliance, other aspects are very much the same. Organizations still have planning and verification activities to perform. They will now be able to do so confidently using a more streamlined approach.

Key GAMP 5 updates 

Overall, the new addition of GAMP 5 encourages organizations to move toward greater adoption of digital transformation to better maintain compliance. We see two main changes of which organizations must be aware:

  1. Digital transformation is welcome: GAMP 5 2nd edition includes six new and two updated appendices. These changes are largely related to new technologies (AI/ML, blockchain, and cloud computing), processes (Agile and critical thinking), and infrastructure (software tools and IT infrastructure). They aim to answer questions companies have been asking for some time around new technologies, such as “how do I bring my pharmacovigilance system’s AI/ML solution for natural language processing and analytics into compliance?” With this guidance, many organizations may feel more confident in moving forward with their digital transformations while maintaining GAMP compliance.
  2. There’s no need to replace everything, but some work may be required: GAMP 5 2nd edition moves to accommodate the iterative and repeatable release cycles commonly found during Agile implementations while keeping the traditional V-Model available. Updates around IT infrastructure library processes (i.e. Incident, Change, and Release Management) provide a more robust environment for system releases and operational activities. Automation within these processes significantly shortens the time to market and prevents bottlenecks during the product life cycle.

What hasn’t changed in GAMP 5 2nd Edition 

The most important thing of which to be aware of is that the same core process still applies within GAMP 5 2nd edition. This is why the update is not “GAMP 6”.

To maintain GAMP 5 compliance in line with these updates, organizations should continue to have a clear understanding of their product and processes, and manage these products with a life cycle approach supported by a science-based quality management system.  These life cycle processes should be scalable within both the organization and the industry. The guidance also continues to encourage cooperation with quality suppliers and support those suppliers in continuously improving their product development, product service, and product compliance.

How do these updates impact you 

Overall, the GAMP 5 2nd edition answers questions that pharma and Life Sciences companies have been asking since the earliest stages of the digital transformation boom. Better still, this updated guide provides context while maintaining its core processes.

Organizations won’t need to change everything to maintain compliance with these updates. However, organizations do need to improve processes and infrastructure to benefit from today’s new technologies, and this new edition brings welcome light to the topic of how to most effectively make those changes.

In the following weeks, we will bring additional insight into the main changes in this guidance, so stay connected and join us in this new phase of GAMP 5. In the meantime, if you have questions regarding these changes or GAMP compliance in general, contact us.

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