ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept

ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept

International Society for Pharmaceutical Engineering, 2012

433,00 €

Détails

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 facilitate
the 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.

Informations supplémentaires

Auteur International Society for Pharmaceutical Engineering
Edité par ISPE
Type de document Guide
Thème /subgroups/37880
EAN ISBN 9781936379460
Nombre de pages 56
Mot-clé 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