Topic: Quality Assurance & Control

• › Articles (348)
• › White Papers (96)
• › News (65)
• › Products (101)

Afnan: Channeling Don McLean
Standard work definitions, and recognized standards, will improve drug manufacturing—not nostalgia, or the insistence that “pharma is different.”

From the Editor: Pangloss or Popper: Has Drug Manufacturing Advanced in the Past Decade?
Can drug manufacturing reach its potential without standards, science and an admission that there’s a need for improvement?

The Continually Improving Pharma Quality System
Highlights of current industry issues and reasons why the manager is no longer the manager.

The Pulse of Pharmaceutical Manufacturing
The big picture has changed very little in ten years. While pointing out root causes, observers also see reasons for optimism.

More Articles »

White Papers: In Depth Research

Implementing 5S Workplace Organization Methodology Programs In Manufacturing Facilities
Author: Lista
Posted: 04/11/2012
Many manufacturing facilities have opted to follow the path towards a “5S” workplace organizational and housekeeping methodology as part of continuous improvement or lean manufacturing processes.

How to Respond to (and Avoid) FDA 483s
Author: Veriteq, a Vaisala company
Posted: 01/24/2011
This article shows excerpts from recent 483s issued for deviations tracking in tracking and recording environmental parameters in various applications and facilities. The article outlines ten best practices of a 483 response, providing a checklist to make the15-day response time limit more manageable. Included are multiple links to further reading, agency guidelines, and disputation information.

Industry Insight: Facilitating Continuous Improvement
Author: Waters Corp.
Posted: 10/04/2010
How quality by design eases method transfer to more efficient analytical instrumentation in the pharmaceutical industry.

Joining Forces: Bringing Pharma Supply Chain Management and Supply Quality Management Together
Posted: 08/03/2010
For years, drug manufacturers have been caught between two opposing forces – supply chain management and supply quality management. The only way to confront these challenges is to create a “culture of quality” that begins at the top and permeates down through the supply chain. This paper looks at how it can be done.

More White Papers »