GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advances.
Reflecting current regulatory expectations and good practices for automated/computerized systems, the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions. They typically focus on the “how”.
Published: November 2010 Pages: 124 Table of Contents Special Pricing for Emerging Economies The GAMP ® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides guidance in setting up a calibration management
Published: October 2020 Pages: 176 Table of Contents Special Pricing for Emerging Economies Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation
Published: October 2018 Pages: 196 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP ® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support data integrity within a regulated
The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them.
Published: February 2017 Pages: 164 Table of Contents Special Pricing for Emerging Economies As organizations find themselves operating from multiple sites worldwide, with groups and departments split between multiple geographies, or even using third
Published: February 2010 Pages: 144 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP ® Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach uses a complete lifecycle approach to the
Published: February 2011 Pages: 196 Table of Contents Special Pricing for Emerging Economies The GAMP ® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP ® Good Practice Guide: Validation of Process
Published: January 2010 Pages: 216 Table of Contents Special Pricing for Emerging Economies During the operational life of a GxP system, regulators usually focus on the integrity, consistency, and completeness of controls required to maintain
The drive within life sciences to improve patient safety and product quality, and provide value to society, while reducing costs requires constant and effective innovation. However, because the pharmaceutical industry operates in a highly regulated sector, some practitioners may apply unthinking, prescriptive, and rigid approaches that are not commensurate to the needs of the process, the nature of the system, and the real risk to the product and the patient.
This Guide helps the reader to maximize testing efficiency without compromising the quality of GxP Systems by focusing testing on areas that have the greatest impact and eliminating duplicate testing. This GAMP Good Practice Guide conforms to GAMP® 5 standards and terminology and reflects ICH Q8, Q9, and Q10, Quality by Design, and Process Analytical Technology principles.