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ISPE Baseline Guide: Volume 2 - Oral Solid Dosage Forms

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ISPE Sustainability Handbook

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ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System

Original price was: $410.00.Current price is: $246.00.

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2012

Description

This Guide aims to provide descriptions of good practices for change management. The modern pharmaceutical quality system described in ICH Q10 is a holistic approach which helps to facilitatethe consistent development and production of high quality pharmaceutical products. The ISPE PQLI GPG: Change Management System describes potential product lifecycle approaches to the change management system element of a pharmaceutical quality system. These approaches can help to achieve the opportunities described in ICH Q10.