Gain industry knowledge, learn best practices, network with peers, and advance your career with the largest not-for-profit association in the pharmaceutical industry.
Join now and get Member Pricing on your purchase!
Guidance Document License Agreement
The contents of ISPE’s guidance documents, both printed and digital, are protected by law and intended solely for the personal non-commercial use of the individual purchaser.
Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited.
Membership discounts are available only to current members and are intended for individual use of the guides, not for resale.
View the Guidance Document License Agreement
The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under GEP that support and enable the ...
The importance of data integrity is reflected in guidance, citations, and public comments of Regulators and Health Agencies. A number of companies ...
This GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP® Good Practice Guide: Validation of ...
During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness of controls required to mainta...
This new GAMP Good Practice Guide is intended to provide a risk-based approach to implementing and supporting regulated mobile apps, and will be of...
The Guide uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturi...
The ISPE GAMP Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) applies a structured approach, including risk managem...
This revised GAMP® Good Practice Guide provides comprehensive and up-to-date guidance on the risk-based development, implementation, validation, an...
The ISPE GAMP® Good Practice Guide: Enabling Innovation - Critical Thinking, Agile, IT Service Management provides information to support the adopt...
The ISPE GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice) is intended to provide ...
The ISPE GAMP® RDI Good Practice Guide: Data Integrity - Manufacturing Records provides practical and pragmatic advice on areas such as regulated r...
The ISPE GAMP® RDI Good Practice Guide: Data Integrity - Key Concepts provides detailed practical guidance to support data integrity within a regul...
An engaging three-day event you won't want to miss.