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
Training Options
In-Person and Online Live
GAMP 5 GxP Process Control Training Course
This highly interactive, course describes how the GAMP ® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems , may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course covers recommended good practice based on a life cycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP ® 5 may be practically applied to process control systems. The course covers both regulated company and supplier quality management systems, and the full system life cycle from concept to retirement.
Receive a complimentary copy of the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition)
GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
US$465 value!
GAMP 5, Annex 11/Part 11 Basic Principles Training Course
This three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP ® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
Receive a complimentary copy of the GAMP® A Risk-Based Approach to Compliant GxP Computerized Systems Guide
US$395 value!
GAMP Basic Principles Training Course
This classroom course has been updated to include the new revised EU GMP Annex 11 , and an overview of 21 CFR Part 11 . This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving 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.
Receive a complimentary copy of the GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide
US$395 value!
GAMP Data Integrity 21 CFR Part 11, 2-Day Training Course
The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
Receive a complimentary copy of the ISPE GAMP® Guide: Records and Data Integrity
US$395 value!
GAMP® Data Integrity 21 CFR Part 11, 3-Day Training Course
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
Receive a complimentary copy of the GAMP® A Risk-Based Approach to Compliant GxP Computerized Systems Guide
US$395 value!
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:
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?
