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ISPE GAMP® 5 Second Edition

A risk-based approach to compliant GxP computerized systems

ISPE GAMP® 5 updated to second edition

Since its release in 2008, ISPE GAMP® 5 has provided essential international guidance on GxP computerized systems, validation and compliance for the pharmaceutical industry.

As technologies and processes have moved on, this internationally recognized guidance was updated in July 2022 to GAMP® 5 Second Edition, to provide updated GAMP® guidelines and support the industry’s transition from computerized system validation (CSV) to computerized system assurance (CSA).

Why has ISPE GAMP® 5 been revised?

The second edition is intended to keep IT, software engineering and automation good practices up to date with latest available technologies, services and risk-based approaches. While the main GAMP®  guidelines and appendices remain relevant, some areas have been updated, and some new topics have been added.

Key changes

  • Recognizing the need for software development in large or custom systems to allow for iterative, incremental and exploratory methods, the agile model is promoted as an alternative to traditional linear waterfall methodology
  • The importance of critical thinking has been highlighted and applied to relevant areas throughout the document along with Case for Quality principles, to enable efficient risk-based assurance of software throughout its lifecycle
  • User requirement, functional and design specification details in the development appendices have been updated to allow for an agile software approach
  • The appendix on Electronic Production Records has been updated to reflect cloud-based technology and blockchain, defining expectations for electronic records, electronic signatures and audit trails
  • Operational appendices now reflect the modern Quality Management System (QMS) IT Infrastructure Library (ITIL) approach to software development, as well as updates on topics such as incident and problem management and operational change and configuration management

New appendices

  • IT Infrastructure – reflecting modern GxP infrastructure and infrastructure management, replacing paper based quality and compliance records with digital technologies, automation tools and AI and how these should be applied
  • Critical Thinking – to support a risk-based approach
  • Agile Software Development – focusing on the agile approach to project management and software development in the GxP regulated environment
  • Software Tools – as part of the risk-based approach, traditional documents such as installation, operational and performance qualifications (IQs, OQs and PQs) are transitioning to risk-based records, this appendix addresses appropriate tools for modern software development lifecycles
  • Distributed Ledger Systems (blockchain) – allowing for the use of distributed ledger technology (DLT)
  • Artificial Intelligence and Machine Learning (AI/ML) – recognizing the increasing use of AI and ML, and applying these to GAMP®

What is GAMP®?

GAMP®  stands to acknowledge Good Automated Manufacturing Practice.

The GAMP®  purpose is to act as a reference and help users to maintain a system that produces quality equipment using the theory of prospective validation following a life cycle model.  It has been specifically designed to aid suppliers and users in the Life sciences and Pharmaceutical industries.

Developed to address evolving FDA and other regulatory agency expectations, GAMP® practices are recognized and utilized globally by many regulated companies and their suppliers, and are widely supported by regulatory agencies.

How does Eurotherm aid compliance with ISPE GAMP® 5 second edition?

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Eurotherm recognizes the transformation to modernized risk-based approaches and we’re adapting our project development, tools, templates, procedures and services to suit the agile model in compliance with the revised GAMP® 5 document.

Our GAMP® 5 engineering approach is already helping life science customers to simplify compliance.

  • Project design, construction and engineering support services per ISPE GAMP® 5 good engineering methodology
  • ISPE GAMP® 5 document templates and products with built-in functions to help meet Category 3 and Category 4 requirements
  • Development of digital engineered solutions and services designed to aid GxP compliance in life science applications
  • High-integrity data management solutions (including cloud-based), with tamper-resistant digital data recording, archiving and reporting technologies, designed to help meet the GxP data lifecycle requirements in line with FDA 21 CFR Part 11 and ALCOA+ data integrity principles
  • Industrial automation products and services that aid cybersecurity robustness, helping to protect production processes and data from being compromised by cyber attacks as part of a defense-in-depth strategy

An off-the-shelf turnkey digital engineered solution can help meet GxP requirements

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