ISPE GAMP Good Practice Guides

ISPE Guidance Documents provide the practical, "real world" information you need to stay current with industry best practices and regulatory expectations.

GAMP 5 Guide 2nd Edition:

A Risk-Based Approach to Compliant GxP Computerized Systems:

GAMP 5 Guide 2nd Edition: A Risk-Based Approach to Compliant GxP Computerized Systems provides 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.

GAMP Guide: Records & Data Integrity

ISPE GAMP Guide: Records and Data Integrity provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate, and available throughout their life cycle.

GAMP Good Practice Guides

GAMP Good Practice Guide: Calibration Management 2nd Edition:

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.

GAMP Good Practice Guide: Computerized GCP Systems & Data:

The?ISPE GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data?is intended to provide a risk-based approach to validating diverse?computerized GCP systems in compliance with applicable regulations.

GAMP Good Practice Guide: Enabling Innovation:

The ISPE GAMP Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management provides information to support the adoption of new and improved approaches to software engineering, data management, and “as a Service” offerings (XaaS), including the use of supporting tools. This helps regulated companies facilitate the best use of resources and encourages the application of appropriate and proportionate practices.

GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition:

The GAMP Good Practice Guide: Global Information Systems Control and Compliance (Second Edition) examines the many challenges of deploying a global IT system while complying with the wide range of regulations and guidelines of different countries.

GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition:

The ISPE GAMP? Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) provides a practical, risk-based approach for evaluating these systems, thus eliminating trial and error. By following the principles outlined in the Guide, companies can save time and money, improve communication with external parties and achieve higher quality, better performing systems.

GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition:

The GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is provides to users achieve process control systems that are fit for intended use and compliant with applicable regulations. It also provides recommended good practices based on a life cycle approach for the development, maintenance, and management of process control systems.

GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition:

The?ISPE GAMP??Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition)?is intended to provide comprehensive guidance on meeting regulatory expectations for compliant Information Technology (IT) Infrastructure platforms, both traditional and cloud-based.

GAMP Good Practice Guide: Manufacturing Execution Systems:

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.

GAMP Good Practice Guide: Operation of GxP Computerized Systems:

The GAMP? Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems 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.

GAMP Good Practice Guide: Regulated Mobile Applications

The GAMP? Good Practice Guide: A Risk-Based Approach to mobile applications is intended to provide a risk-based approach to implementing and supporting regulated mobile apps and will be of value to both regulated organizations and mobile app suppliers. It focuses on the unique and specific issues related to mobile apps and provides comprehensive guidance for maintaining compliance and control throughout the lifecycle by applying GAMP? principles.

GAMP Good Practice Guide: Testing GxP Systems 2nd Edition:

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.

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

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.

GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

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. Additionally, system-specific examples of topics such as segregation of duties and critical validation activities to support data integrity are discussed. Included are “quick wins” – suggestions that can create considerable improvement in the integrity of manufacturing system data with only modest resources.

GAMP RDI Good Practice Guide: Data Integrity by Design

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.

ISPE Uday Shetty