ISPE Issues Change-Management Guide
The 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.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
