Compliance & Regulation

What is GAMP®5 and How Does Its Guidance Help Regulated Companies Using Computerized Systems?

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GAMP5

In this blog, we define GAMP®5, the framework for a risk-based approach, with an introduction and conclusion provided by Jakob Khazanovich, Medical Device Solutions Consultant at Jama Software®.

This blog contains details sourced from the International Society for Pharmaceutical Engineering.

What is GAMP®5 and How Does Its Guidance Help Regulated Companies Using Computerized Systems?

When medical product companies decide to implement a new software tool, an important question arises regarding the level of computer system validation required to ensure the latest software complies with regulatory requirements and industry standards.

One major guidance document companies should reference to answer this question is Good Automated Manufacturing Practice (GAMP®5): A Risk-Based Approach to Compliant GxP Computerized Systems.

RELATED: Convergent Dental Selects Jama Connect® For Its Live Requirements Traceability

GAMP

What is GAMP®?

GAMP® is a set of guidelines for producing quality equipment using the concept of prospective validation following a life cycle model. It was specifically designed by the International Society for Pharmaceutical Engineering (ISPE) to aid suppliers and users in the pharmaceutical industry.

GAMP stresses the use of critical thinking and risk-based assessments to justify the testing approach of a software tool. Its guidelines are widely supported by regulatory agencies and are used globally by regulated companies using computerized systems for compliance and validation.

What is GAMP®5?

GAMP®5 refers to the ISPE’s guidance document, “GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems”. This GAMP®5 guide offers a framework for a risk-based approach to computer system validation in which a system is evaluated and assigned to a predefined category based on its intended use and complexity.

Though the steps in this guidance document are not mandatory, the framework provides a comprehensive approach to computer system validation that is generally accepted within the industry.

Additionally, its approach falls in line with the European EMA and US FDA regulations governing computer system validation, Annex 11 and 21 CFR Part 11.

Based on input from experienced IT, automation, and software practitioners, one of the reasons GAMP® guidance has always been successful is because it reflects the good practices for modern IT and software engineering teams.

RELATED: Jama Connect® and FDA 21 CFR Part 11

GAMP®5 Second Edition

Released in July 2022, GAMP® 5 Second Edition prioritizes patient safety and product quality over compliance and encourages the application of critical thinking. The overall GAMP® 5 framework, key concepts, and ICH Q9 aligned Quality Risk Management approach remain unchanged from the First Edition.

GAMP® 5 Second Edition supports standards set for forth by the FDA CDER (Center for Drug Evaluation and Research). Those standards call for “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.”

This updated version of the guideline aims to help teams meet compliance expectations by offering best practices for IT teams, recommendations for optimal Quality Risk Management approaches, and ways to excel in software engineering, all while achieving better product quality and safety.

Conclusion

The risk-based approach to validation is a best practice seen in guidance documents and used by best-in-class medical industry organizations, many of which are Jama Connect® customers. In general, few tools require full validation but should have functionality confirmed through a subset of tests, the scope of which is determined based on the potential risk to the patient or product.

When your organization implements Jama Connect, consider consulting GAMP®5 guidance to avoid non-value-added over-validation and unnecessary constraints on your processes and systems.

Decoteau Wilkerson
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