GAMP® refers to Good Automated Manufacturing Practice. A system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users in the pharmaceutical industry.
Created to address evolving FDA and other regulatory agency expectations for computerized system compliance and validation, GAMP® good practices are used globally by regulated companies and their suppliers, and are widely supported by regulatory agencies (evidenced by the global regulatory input and being referenced in several regulatory guidance documents). (source)
Produced by pharmaceutical manufacturing industry professionals, the GAMP series of Good Practice Guide documents help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions. They typically focus on the “how”.
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advances.
The guide provides a framework for the risk-based approach to computer system validation where a system is evaluated and assigned to a predefined category based on its intended use and complexity. Categorizing the system helps guide the writing of system documentation (including specifications and test scripts and everything in between).(source)
GAMP® Sessions at the 2022 ISPE Annual Meeting & Expo
- Workshop: CSA - The Next Steps for Better Compliance
- Concurrent Session: **NEW** GAMP® 5 Second Edition - An Overview
- Concurrent Session: **NEW** GAMP® 5 Second Edition Roundtable
GAMP® 5 Guide, 2nd Edition: Top Takeaways
Explore GAMP® Hot Topics in 3 Questions
GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts
Training Options
In-Person and Online Live
- GAMP® Data Integrity 21 CFR Part 11 Training Course
- Data Integrity & Compliance for GxP Process Control Systems Online Live Training
- GAMP® 5, Annex 11/Part 11 Basic Principles Online Live Training
On Demand Training
- Basic Principles of Computerized Systems Compliance
- Requirements for Computerized Systems Validation and Compliance
- GAMP® Good Practice Guide for GxP Compliant Lab Computerized Systems - Webinar
- New GAMP® Data Integrity Good Practice Guidance & Experience from the Field - Webinar
GAMP® Guidance Documents
Good Automated Manufacturing Practice (GAMP®), is a technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE). The goal of this committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry. The GAMP committee organizes training guides for its members. These guidelines are:
Pharmaceutical Engineering® Magazine Articles
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iSpeak BlogISPE GAMP® has led the way in computerized systems best practices for more than 30 years. GAMP brought us the concept of system lifecycles and leveraged the V-model to give us a structured approach to computerized systems validation (CSV). GAMP developed and adopted the risk-based approach to CSV, enabling industry to focus validation efforts on critical systems and functionality.
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May / June 2021 Issue
May / June 2021 - It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality initiative—which is promoting a risk-based, product quality, and patient-centric approach to computerized systems assurance—as well as the GAMP® reexamination of approaches to IT infrastructure control and compliance. -
FeaturesIn 2021, the ISPE GAMP® Community of Practice (CoP) is celebrating 30 years of promoting industry good practice for computerized systems and encouraging technical innovation and progress, while protecting patient...
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FeaturesThe US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation-driven approaches.
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Concept & Discussion Papers
- GAMP 5: Implementation & Operation of GxP Compliant Clinical System
- Using SaaS in a Regulated Environment – A Life Cycle Approach to Risk Management
Communities of Practice
As an ISPE Member, join an ISPE community of practice to participate in discussions on specific topics with your peers. Learn more about Communities of Practice.