cGMPs and Compliance Resource Center

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Focus on Pharma Podcast: Episode 3: Inside the FDA and the New Transparency Initiative
PharmaManufacturing.com
Accused of being too chummy with the drug industry, FDA has moved to improve transparency. CDER's Helen Winkle discusses the initiative's progress.

From Harmonization to Inspections: An FDA Update
A talk with FDA’s CDER Office of Compliance's Division of Manufacturing and Product Quality about the state of regulatory harmonization, enforcement, and priorities for the future.

From the Editor: Are You Myopic About Risk?
Two years after the heparin disaster, the drug industry is still vulnerable to major quality, safety and security risks.

PharmaView: The Great Swine Flu Conspiracy: The Plots Thicken
Was it wrong to be prepared and a bit lucky?

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White Papers: In Depth Research

FDA Transparency Initiative: Opening FDA's 'Black Box'
Author: Afia K. Asamoah, published by FDLI
Posted: 02/23/2010
Transparency promotes accountability, enhances the work of the agency, and increases its credibility with the public. This article by FDA's Special Assistant to the Principal Deputy Commissioner, Afia K. Asamoah, and published by FDLI outlines opening the proverbial 'black box' to help FDA more effectively implement its mission to promote and protect the public health.

Enhancing Collaboration with the FDA Through MedWatch Plus
Author: ETQ Inc.
Posted: 02/08/2010
This white paper will provide an overview of the benefits and best practices of using the FDA's MedWatch Plus initiative for electronic adverse event reporting within the pharmaceutical industry, as well as other FDA-regulated organizations.

Accounting for Risk in Your Asset Management Strategy
Author: Life Cycle Engineering
Posted: 09/23/2009
A risk-based asset management system will help you appropriately prioritize how you spend time, money and materials fixing the most critical problems, provide the infrastructure for continuous improvement and help you meet your corporate business objectives, including regulatory compliance. This paper offers an overview of the three key elements of an asset management strategy and presents the six steps to building a robust, risk-based asset management program.

Integrating Good Manufacturing Practices During the Transition from Clinical Trials to Commerical Manufacturing
Author: CDC Software
Posted: 06/11/2009
Our experience shows that early adoption of GMP (Good Manufacturing Practices) by a company, can lead to a faster, lower-cost ramp-up from clinical trials to full commercial manufacturing, in-house or out-sourced. The interpretation of compliance regulations, and subsequent recommendations in this document, are a compilation of years of experience and best practices from leading bio/pharmaceutical companies.

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