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 regulations...
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
Dave DiProspero, Co-Team Leader of the ISPE Baseline® Guide: Oral Solid Dosage Forms (Third Edition), offers insight about what brought on the update and what core takeaways you’ll get from the new edition of this Guide...
ISPE announced the release of their latest guide, ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records. This guide features the expectations and requirements for data integrity and quality management in GMP facilities. Industry...
