GAMP® guidance aims to safeguard patient safety, product quality, and data integrity in the use of GxP computerized systems. It aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements by building upon existing industry good practice in an efficient and effective manner. GAMP® adopts a patient-centric risk-based approach that enables innovation while demonstrating compliance with regulatory requirements. GAMP® is an ISPE Community of Practice (CoP).
GAMP® provides practical guidance that:
- Facilitates the interpretation of regulatory requirements
- Establishes a common language and terminology
- Promotes a system life cycle approach based on good practice
- Clarifies roles and responsibilities
GAMP® guidance does not define a prescriptive method or a standard, but rather provides pragmatic guidance, approaches, and tools for the practitioner.
The ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems Second Edition aims to protect patient safety, product quality, and data integrity by facilitating and encouraging the achievement of computerized systems that are effective, reliable, and of high quality. Technological innovation is essential for life sciences industries in providing value to society while also controlling costs and reducing time to market. The Guide facilitates the effective and efficient use of valuable resources by the application of appropriate and proportionate practices, encouraging innovative approaches to managing risk to patient safety, product quality, and data integrity, while supporting benefit to public health.
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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iSpeak BlogIn the previous blog, GAMP® Support for Pragramtic Quality & Risk-Based Approaches, we saw how as part of the Case for Quality program US FDA CDRH (Center for Devices and...
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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.
Other Resources
- The Difference Between Industry Standards: GAMP, ASTM, and ICH
- Understanding and Interpreting the New GAMP 5 Software Categories
- What is GAMP®5 and how do I use it effectively?
