Quality Assurance Control Resource Center

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Demystifying GMPs for Nutritional Supplements
PharmaManufacturing.com
Like drugs, dietary supplements must also be manufactured consistently as to their identity, purity, strength, and composition.

Podcast: Pfizer’s Michael Arnold Visits the Pharma “Mother Ship”
PharmaManufacturing.com
The place to be at ISPE was QbD—that is, the main discussion track at this year’s ISPE annual show in Boca Raton focused on developing QbD for investigational drug products. Pfizer’s global business supply head Michael Arnold witnessed it all, and shares his thoughts on China, FDA, Cost Reduction, and the “Mother Ship.”

From the Editor: Deconstructing Murphy
PharmaManufacturing.com
What if FMEA and tools like it were used not to solve isolated quality problems, but to manage risk throughout organizations and product lifecycles?

Don’t Drift out of Control
PharmaManufacturing.com
For sensors, data integrity is the measure of their performance.

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White Papers: In Depth Research

“Thin LIMS” IT Implementation Strategy for cGMP Quality Informatics
Posted: 11/14/2008
This white paper examines an alternative “Thin LIMS” strategy that promises to eliminate "scope creep" and cut the technical resources and costs required for deployment in half

GAO: FDA Lacks “Clear and Effective Processes” for Postmarket Safety
Author: GAO
Posted: 10/27/2008
FDA needs to better track postmarket drug safety issues, and improve its decisionmaking—these the key findings of a recent report from the government accountability office.

Complimentary Reports: Pharmaceutical Domain Management and Protecting Pharmaceutical Brands
Author: MarkMonitor
Posted: 10/08/2008
With all the online challenges today's global pharmaceutical companies face -- illicit Internet pharmacies, gray-market drugs, trademark abuse and more -- it's simply too risky to complicate matters with a fragmented domain management process.

How New Technologies Can Improve Compliance in Pharmaceutical and Biotech Manufacturing
Author: Justin Neway, Aegis Analytical
Posted: 08/12/2008
While U.S. drug products are of high quality, there has been an increasing trend towards manufacturing problems, resulting in recalls, disruption of operations and drug shortages. Companies are missing billions of dollars of potential additional revenue, and necessary medications are sometimes unavailable to the public. By enforcing 21 CFR Part 11 and introducing additional new quality-related initiatives, the FDA is signaling a need for better compliance to ensure consistency and safety. The industry wants to comply, but many manufacturers lack the necessary capabilities, or are unaware that new technologies are available to meet the beefed-up regulatory demands and still operate efficiently and profitably. Justin Neway, Ph.D., executive vice president and chief science officer of Aegis Analytical Corporation examines why these problems occur and how new technology can improve the manufacturing process.

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