GAMP 5 advises that computer systems should be evaluated and categorized based on their intended use and complexity. This technique is conveniently similar to the V-model in software development, which uses the system testing process to verify specifications and requirements. Let’s see a few benefits of using the GAMP 5 approach below.
The framework contained in GAMP 5 is meant to lower risks associated with automated manufacturing processes and products. It provides an extensive approach for computer system validation as accepted within the pharmaceutical and related industries.
GAMP 5 outlines the compliance regulations from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It helps regulated companies to match the crucial expectations for 21 CFR Part 11, Annex 11, and also computerized system validation (CSV).
GAMP 5 promotes a risk-based approach to system testing to ensure that companies focus mostly on high-risk areas of the system. Likewise, it also uses testing to validate the automated system efficiently and confirm that it works as intended.
The GAMP Good Practice Guides are available to support companies who follow the GAMP 5 risk-based approach. Furthermore, the reference materials convey best practices for automation in conjunction with useful tips for performing the validation of different systems.
GAMP 5 was created to meet the evolving FDA expectations for GMP compliance of manufacturing and related systems. It’s also compatible with international standards such as IEEE standards, ISO 9000, ISO 12207, IT Infrastructure Library (ITIL), and others.
The GAMP 5 second edition embraces a dynamic and flexible approach since today’s software and cloud-enabled applications demand continuous improvements. It recommends the agile methodology since it allows for the use of an iterative, incremental, and exploratory approach.
Both the GAMP5 second edition and the FDA’s guidelines from September 2022 emphasize how critical thinking helps to ensure the integrity of computerized systems. The new GAMP edition promotes a more efficient and risk-based approach tailored to the software’s unique risk profile. It also enhances the focus on critical thinking, offers clear guidance on where to apply it, and dedicates a new appendix to the topic of critical thinking to enrich the document’s content.