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
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:
Commissioning & Qualification (1)
+Data Integrity (15)
+GAMP® (16)
+Knowledge Management (1)
+Lifecycle Management (1)
+Manufacturing Operations (1)
+Regulatory (1)
+Validation (12)
+Community Discussions
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Dec 20, 2024
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Dec 04, 2024
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Sep 30, 2024
GAMP®
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iSpeak Blog Posts
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…
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ISPE GAMP® Blockchain Special Interest Group
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iSpeak Blog
ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track!
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iSpeak Blog
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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…
iSpeak Blog
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GAMP® 5 Second Edition is here! Since its publication, GAMP® 5 has been far and away the leading…
iSpeak Blog
Digital Transformation: Control, Prediction, and Optimization
Digital transformation is the novel use of digital technology, including instrumentation and control…
iSpeak Blog
Advancing Digital Transformation at the 2024 ISPE Annual Meeting & Expo
Rise of the Machines It becomes clear that a topic has become mainstream when it crosses multiple…
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…
Pharmaceutical Engineering Magazine Articles
PE Articles
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PE Articles
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PE Articles
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Recent advances in artificial intelligence (AI) have led to its widespread industrial adoption, with…
PE Articles
Applying GAMP® Concepts to Machine Learning
This article explores life-cycle activities for machine learning (ML) within regulated life sciences…
PE Articles
Message from the Chair: GAMP® Rings in the New Year
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PE Articles
Artificial Intelligence Used to Optimize Fluid Bed Drying
This article shows how non-supervised artificial intelligence (AI) methods can strongly support…
PE Articles
Remote Acceptance Testing of Automation Projects
Before the COVID-19 pandemic, it was unthinkable for a system integrator to suggest remotely…
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…
PE Articles
The Use of Infrastructure as Code in Regulated Companies
IT infrastructure has traditionally been provisioned using a combination of scripts and manual…
PE Articles
Quality Considerations in Disaster Recovery: A Case Study
Due to the growing digitalization of the industry, we are highly dependent on information technology…
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GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course
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Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
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This article aims to refresh information on open-source software (OSS) within regulated computerized…
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