Packaging Line GMP Optimization

This case study on packaging line GMP optimization is the sixth of eight in a series put together by the Product Quality Research Institute Manufacturing Technical Committee (PQRI-MTC) risk-management working group. The series is meant to advance the understanding and application of the Internationa...

Full description

Saved in:
Bibliographic Details
Published in:Pharmaceutical Technology 2011-12, Vol.35 (12), p.46
Main Authors: Frank, Ted, Brooks, Stephen, Murray, Kristin, Reich, Steve, Sanchez, Ed, Hasselbalch, Brian, Obeng, Kwame, Creekmore, Richard
Format: Article
Language:English
Subjects:
Case studies
Compliance
Failure
Good Manufacturing Practice
International conferences
Manufacturing
Optimization
Packaging
Pharmaceutical industry
Pharmaceutical sciences
Product quality
Quality control
Risk assessment
Risk management
Working groups
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:This case study on packaging line GMP optimization is the sixth of eight in a series put together by the Product Quality Research Institute Manufacturing Technical Committee (PQRI-MTC) risk-management working group. The series is meant to advance the understanding and application of the International Conference on Harmonization (ICH) Q9 Quality Risk Management guideline by providing actual examples of risk-management assessments used by the bio/pharmaceutical industry. The introductory article and first case study, on defining design space, appeared in the July 2011 issue of Pharmaceutical Technology(1). [PUBLICATION ABSTRACT]
ISSN:1543-2521
2150-7376