ISPE announced the release of its latest guide, I SPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It . The Guide was cultivated by leading experts to help pharmaceutical organizations achieve and...
The design, construction, commissioning, qualification, and continued performance of water and steam systems for the pharmaceutical industry present significant challenges. These systems need to meet Good Manufacturing...
Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process...
ISPE announced the release of its latest guide, ISPE Good Practice Guide: HVAC & Process Equipment Air Filters . This guide provides readers with a better understanding of current technologies and their application as it relates to current...
A Road Map to Implement Single-Use Technology Single-use technology (SUT) has grown in both complexity of design and criticality of application in the past twenty years, offering increased flexibility while significantly...
ISPE announced the release of its latest guide, ISPE Baseline® Guide: Water and Steam Systems (Third Edition) . This guide provides in-depth guidance for the design, construction, operation, and lifecycle management of water and steam systems...
ISPE announced the release of their latest guide, ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) . This Guide provides practical guidance on the implementation of a science and risk-based approach for the commissioning and...
Attachments for GAMP Good Practice Guide: Calibration Management