CaseBioscience joins an ARPA-H effort to develop room-temperature cell therapy preservation, Novartis licenses an mRNA-encoded T-cell engager from Abogen, and AstraZeneca, Daiichi Sankyo, and Summit plan to combine Datroway with ivonescimab.
|Articles|June 5, 2012
ISPE Issues Change-Management Guide
Author(s)Patricia Van Arnum
The new guide outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system.
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The International Society for Pharmaceutical Engineering (ISPE) has released the latest volume in the Product Quality Lifecycle Implementation (PQLI) series,
The PQLI guide on change management outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system (PQS). It provides guidance on achieving compliant and consistent change-management systems and describes how to implement compliant change-management systems within a PQS. PQLI 3–Change Management can be used in conjunction with the first two PQLI guides as part of a larger quality-by-design approach or as a stand-alone change-management manual.
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