cGMPs and Compliance 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.

ICH Guidances (Already) Show Their Age
PharmaManufacturing.com
ICH guidelines can be powerful tools for PAT/QbD, but some, such as ICH Q2 (R1), need updating.

Certified Pharmaceutical GMP Professional
PharmaManufacturing.com
The American Society for Quality is introducing a testing and certification program for professionals who have five or more years of industry experience. Here to explain more about the program and its genesis is Robert Seltzer, a pharmaceutical quality executive with a leading drug company and a senior member of ASQ.

Safe Materials from Overseas: What Tools Does FDA Have?
PharmaManufacturing.com
Material safety is an industry issue, not an Agency issue.

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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

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.

Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT
Author: Aegis Analytical
Posted: 08/11/2008
Process improvement and Quality by Design become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time instead on productive science-based collaboration. This is the best way to undertake the Design Space Development, Design for Manufacturing and PAT efforts needed to achieve manufacturing process excellence using the principles of Quality by Design.

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