Quality Assurance Control Resource Center

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From The Editor: First, Do No Harm
Modern control is the best way to ensure patient safety (and corporate survival).

Studying Outliers to Ensure Ingredient and Product Quality
Out-of-trend results from APRs offer unique insights into ingredients and finished products.

PharmaView: Fake Drugs: Why Business is Booming
It’s time to make counterfeiting less economically tantalizing.

QbD: Redefining Time to Market
For manufacturers who lack formulation and process knowledge, the benefits of getting to market fast can be outstripped by the costs of unexpected failures.

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White Papers: In Depth Research

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.

The New Approach to Track and Trace
Author: Cognex Corp.
Posted: 06/14/2010
A new leaner, more cost-effective approach to track and trace demands new technology. Due to advances in the power of digital signal processors (DSP), imaging sensors and decoding algorithms, traceability applications such as ID code reading, text verification, mark quality assessment, and label inspection can now be accomplished more economically using the latest generation of smart camera vision systems.

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