cGMPs and Compliance Resource Center

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Pharma Water Everywhere, but Little Consistent Guidance
Guidelines for pharma grade water have varied and often been a moving target. Pfizer's Cameron Sipe explains the importance of ISPE's new guidelines.

Afnan to FDA: Simplify Post-Approval Changes, Spur Innovation
21 CFR 314.70, and the process by which FDA reviews changes to already approved applications, needs a risk-based update, now. Consultant Ali Afnan, formerly with FDA, makes his case.

Pharma's Changing Strategic Planning Landscape
The last few years in the pharmaceutical industry have seen unprecedented upheaval, with changes to the marketplace on all fronts. In the U.S., consolidation on a massive scale amongst the elite of the industry raises new questions about competitiveness and what it takes to keep it.

Computer System Validation: Are You Ready for an Inspection?
The topic of CSV inevitably comes up in FDA Inspections. Here's how to make sure you're prepared.

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White Papers: In Depth Research

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.

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.

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