Topic: Quality Assurance & Control

• › Articles (186)
• › White Papers (75)
• › News (102)
• › Products (73)

Quality Systems Dominate at Interphex Dalian
PharmaManufacturing.com
Pharmaceutical Manufacturing Digital Managing Editor traveled to Dalian, China for the INTERPHEX China show this May.

Benchmarking: Measuring Up
PharmaManufacturing.com
The industry is adopting benchmarking with a vengeance, to good effect.

Controlling Pharmaceutical Manufacturing Mistakes
PharmaManufacturing.com
Process complexity is the leading source of pharma quality problems, and error proofing offers a sure return on investment.

Lean Pharma: If Only It Were This Easy
PharmaManufacturing.com
Our latest operational excellence survey suggests that tools aren't always aligned with goals, and that more management support is needed.

White Papers: In Depth Research

A Perspective on Standards
Author: Rockwell Automation
Posted: 12/17/2007
This white paper by Rockwell Automation features executive viewpoints from leading standards, trade and conformity assessment organizations on why standards and regulations are important to global business, and why industry should care.

Official File : Novartis Complaint
Posted: 07/27/2007
This is the official filed action against Novartis Pharmaceutical Corporation for violating a whistleblower's rights under the New Jersey Conscientious Employee Protection Act and retaliating against him for refusing to participate in illegal and unethical activities regarding the testing and reporting of human drug study results concerning Novartis' new cancer drug, Tasigna.

A Guide to the GMP Requirements of PS 9000 : 2001 Pharmaceutical Packaging Materials
Author: The Institute of Quality Assurance
Posted: 07/16/2007
This comprehensive guide written by The Institute of Quality Assurance is aimed at increasing the awareness of the quality management system requirements embodied in PS 9000. It adopts a risk assessment approach to the identification and implementation of preventive action and uses case studies to illustrate areas of GMP risk.

Environmental Testing : Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers
Author: Microtest Laboratories
Posted: 07/10/2007
Industrial sterilization and contamination control programs are critical in pharmaceutical and medical device manufacturing. This article by Microtest Labs reviews the key elements of a best practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments. In this paper, the author draws on his extensive experience assisting clients with program development. He reviews strategies that range from the essentials of compliance to budget development and management.

More White Papers »