Good Automated Manufacturing Practice (GAMP)

News & Press Releases
25 October 2018
ISPE announced the release of their latest Guide, ISPE GAMP ® RDI Good Practice Guide: Data Integrity – Key Concepts . This publication provides detailed practical guidance to support data integrity within a regulated organization. "In recent years...
Product
The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support data integrity within a regulated organization. In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which a regulatory decision is based.
Insights
Ten years after its publication, the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems is regarded as the definitive industry guidance on GxP∗ computerized system compliance and validation for companies and suppliers and is...
Insights
The importance of ensuring data integrity is reflected in guidance, citations, and public comments of regulators and health agencies. A number of companies have suffered serious regulatory and financial consequences as a result of unacceptable...
Training
This global SIG coordinates GAMP concepts in promoting the understanding of validation and compliance aspects within R&D, and of clinical computerized systems, with a focus on ensuring data integrity and patient safety....
Training
This GAMP 5 GxP Process Control Training Course describes how the GAMP® Good Practice Guide: A Risk Based Approach to GxP Process Control Systems, may....
Training
This classroom course will be an explanation of the GAMP approach to 21 CFR Part 11 compliance, as well as compliance with other international....
Training
This GAMP Data Integrity 21 CFR Part 11 Classroom Training Course will cover data integrity, electronic records and signatures, and the compliant....
Guidance Docs
Published: March 2017 Pages: 152 Table of Contents Special Pricing for Emerging Economies The importance of ensuring data integrity is reflected in guidance, citations, and public comments of Regulators and Health Agencies. A number of companies have