GAMP Good Practice Guides

This revision adds information on modular systems/plants, software tools, cloud and SaaS interfaces, cybersecurity, and AI, along with leveraging C&Q activities during computerized system validation. The content, aimed at regulated companies and suppliers, has also been aligned with recently published ISPE GAMP® Guides, including ISPE GAMP® 5 (Second Edition).

The Guide discusses the increased complexity of hybrid or participant-centric decentralized trials. The Guide offers best practices for managing this complexity, which is caused by various factors such as a greater reliance on contractor/subcontractor processes and the use of participant-owned digital health technologies and devices (for example, a smart phone).

The GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides guidance in setting up a calibration management system, which will give a structured approach to instrument risk assessment, calibration program management, documentation, and corrective actions, essential to regulatory compliance.

This ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design supports organizations as they embrace and implement a holistic approach by leveraging data governance and knowledge management activities to drive continual improvement in data integrity. The Guide promotes a patient-centric mindset, focusing resources and management attention on quality best practices that inherently facilitate meeting regulatory compliance requirements.

This Guide provides guidance on how to integrate tools such as Cultural Excellence and critical thinking skills into data integrity practices which can help companies meet regulatory requirements and expectations. Numerous examples of good data integrity practices along with ways to identify risks and detect issues are included to assist organizations in developing or raising their data integrity awareness.

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.

The Second Edition includes comprehensive and up-to-date guidance on the risk-based development, implementation, validation, and maintenance of GxP regulated global information systems and is fully aligned with GAMP® 5. It reflects changes in typical system architecture since the First Edition and also covers Software as a Service (SaaS) and other cloud solutions.

The ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interaction to facilitate the operation of an organization. It collects and integrates information and knowledge from many disciplines and sources into a single comprehensive guideline.

The GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems highlights the importance of the operation phase of the system lifecycle, when it is more likely that the return on investment will be achieved for the significant time and resources expended in implementing new computerized systems. The Guide will help regulated organizations create regulated computerized systems that are fit for intended use and compliant with applicable regulations and provides comprehensive guidance for maintaining control of regulated systems throughout their operational life.

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.