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.
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GAMP® Guidance Documents
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:
Artificial Intelligence (1)
Commissioning & Qualification (1)
Data Integrity (15)
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP Good Practice Guide: Manufacturing Execution Systems
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
GAMP® (16)
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP Good Practice Guide: Manufacturing Execution Systems
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Knowledge Management (1)
Lifecycle Management (1)
Manufacturing Operations (1)
Validation (11)
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
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iSpeak Blog Posts
iSpeak Blog
The Importance of GAMP® in the Pharmaceutical Industry
In the pharmaceutical industry, ensuring the safety, quality, and efficacy of products is paramount…
iSpeak Blog
Hacker to GAMPer: Year One
In this blog post, ISPE Emerging Leader member Peyton Myers, details his experience in his first…
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Advancing Digital Transformation at the 2024 ISPE Annual Meeting & Expo
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iSpeak Blog
What you need to know about the GAMP track: 2024 ISPE Europe Annual Conference, 16 – 18 April
The ISPE GAMP ® 5 Guide (Second Edition) was published on 29 July 2022. It was presented and…
iSpeak Blog
The Machine Learning Life Cycle (MLLC): Key Artifacts, Considerations, and Questions
It is an exciting time in life sciences. Many companies have focused initial artificial intelligence…
iSpeak Blog
ISPE GAMP SIG MES Planning to Move the Industry Forward
With a recent increase in interest and participation, the ISPE GAMP® Special Interest Group (SIG)…
iSpeak Blog
Manufacturing Execution Systems & Electronic Production Records Management: A Building Block for Pharma 4.0™ & Your Organisation’s Digitalization Journey
When discussing manufacturing execution concepts and practices, it is useful to first take a top…
iSpeak Blog
ISPE GAMP® Blockchain Special Interest Group
The ISPE GAMP ® Blockchain Special Interest Group is excited to be in its 4th year! For those of you…
iSpeak Blog
Validation of Interfaces - Ensuring Data Integrity and Quality across Systems
The lifecycle of interfaces is of crucial importance for the interoperability of systems from…
iSpeak Blog
ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track!
GAMP ® 5 (Second Edition) was published on 29th July 2022 and was presented and discussed at the…
iSpeak Blog
IT Infrastructure in the Current Life Science Company Environment
A look through the lens of GAMP 5® Second Edition IT Infrastructure is a broad term that encompasses…
iSpeak Blog
Why We All Need Critical Thinking
It may seem that the only things loved by pharma industry more than acronyms are new buzz phrases…
Pharmaceutical Engineering Magazine Articles
PE Articles
AI/ML Technology: Harnessing AI/ML Technology for the CQV Life Cycle
Technology is advancing at an extraordinary rate. Industries are benefiting from automation and AI…
PE Articles
Volunteer Profile: Brandi Stockton, GAMP® Americas Community of Practice Chair
Brandi Stockton is Founder of The Triality Group, LLC, where she provides quality, regulatory, and…
PE Articles
Volunteer Profile: Mark Cherry, GAMP® Europe Community of Practice Chair
Mark Cherry is the IT Compliance Director and GXP subject matter expert at AstraZeneca. A chartered…
PE Articles
Celebrating 25 Years of GAMP® Americas
This special anniversary article addresses the history and milestones that define the GAMP Community…
PE Articles
Removing the Frustration from Functional Risk Management
Risk assessment is essential, however, risk assessment is of limited value if it is not conducted by…
PE Articles
A GAMP® Approach to Computerized System Life Cycle and IT Process Records
This article describes a practical and pragmatic approach to the management of computerized system…
PE Articles
Updated GAMP® GPG Incorporates AI and Open-Source Software
The landscape of clinical trials has been transformed in a post-pandemic world. In July, ISPE…
PE Articles
ISPE Releases New GAMP® Good Practice Guide
This summer ISPE released the ISPE GAMP® Good Practice Guide: Validation and Compliance of…
PE Articles
A Cloud Service Provider Exit Strategy
Traditionally, a regulated company is accountable for all aspects of their infrastructure…
PE Articles
Finding the Assurance in Computer Software Assurance
Computer software assurance (CSA) has been discussed widely in industry over the past five years…
PE Articles
Computer Software Assurance and the Critical Thinking Approach
In 2022, the US Food and Drug Administration (FDA) issued their draft guidance “Computer Software…
PE Articles
Leveraging GAMP® 5 Second Edition for Medical Devices
This article provides a brief introduction into the standards and regulations for medical devices…
Videos
Professional Development Training
ICH Q8: QbD in Manufacturing
The ICH Q8 guideline ensures a systematic approach to pharmaceutical development by defining globally recognized Quality by Design (QbD) principles to enhance product quality throughout all stages of development.
A GAMP® Guide to Computerized Systems Compliance
Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide This fundamental online 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. Course Modules…
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 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…
Requirements for Computerized Systems Validation and Compliance
This online course describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except for the requirement that systems be validated. Even though it draws upon medical device guidance, it is not intended to cover all the requirements of producing software that subsequently becomes part of a medical device.
Cloud Concepts - Cyber Security and Block Chain
This online course will explore the pros and cons of cloud-based computing. Attendees will gain an understanding of what "the cloud" is and how it's both different, and similar, in comparison to software solutions that run on company-owned servers. Data concerns will also be addressed and aspects of regulatory compliance will be explored and answers on how one can comply will be provided. If already operating in the cloud, attendees will be gain insight on how they can assess their own company's cloud platform, and take proactive measures to resolve any vulnerabilities.
GAMP® Basic Principles 2-Day Training Course
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.
GAMP® Basic Principles 3-Day Training Course
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. Please click the "Locations and Registrations" table to select the two or three-day sessions.
GAMP® 5 GxP Process Control Training Course
This highly interactive classroom course describes how the GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Process Control Systems, and GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records may be applied to achieve process control systems that are fit for intended use, incorporate data integrity and meet current regulatory requirements.
GAMP® Data Integrity 21 CFR Part 11, 3-Day Training Course
This GAMP Data Integrity 21 CFR Part 11 Training 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.
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January / February 2025
GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…
January / February 2024
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
March / April 2022
This article aims to refresh information on open-source software (OSS) within regulated computerized…
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