ISPE Issues Change-Management Guide
New guide outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system.
The International Society for Pharmaceutical Engineering (ISPE) has released the latest volume in the Product Quality Lifecycle Implementation (PQLI) series, Change Management System as a Key Element of a Pharmaceutical Quality System. The guide, which is Part 3 of the PQLI series, provides practical, real-world strategies that companies can use to implement the change-management recommendations of ICH Q10.
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.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
