cGMPs and Compliance Resource Center

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

Materials ID: The More the Merrier in the Handheld Device Market?
Capable new Raman-based and other handheld technologies are proliferating as drug manufacturers see the need for quick, mobile raw materials inspection capabilities.

The FDA Wants More Authority
FDA’s risk management programs must be funded and allowed to continue to evolve, but in a way that doesn’t hinder progress.

Process Validation Guidance: A Bad Fit for Aseptic Processing?
“Science-based” is well and good, but FDA’s guidance may create confusion.

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White Papers: In Depth Research

Evaluating Library Databases for Microbial Identification: Critical Aspects and Recommendations
Posted: 07/07/2011
A thorough evaluation process for microbial identification systems should consist of both a technical and financial review, regardless if you are performing internal testing and outsourcing. All evaluations should include a detailed list of specifications to meet your laboratory’s objectives. Most laboratories perform evaluations by examining obvious system attributes and tangible features: work flow, automation, labor and technical requirements, cost of reagents and consumables, capital expenses and interfacing with laboratory information systems. A key component often neglected in the review process is the impact and effect of library databases on performance in a pharmaceutical environment, including comparing comprehensive depth of library entries, accuracy and relevancy to obtain a species level identification.

Reducing Airborne Contaminants with Polymeric Floor Coverings
Posted: 07/07/2011
A major medical device manufacturer has recently revealed significant airborne reduction counts. The facility based in the USA achieved this result by evaluating their contamination control methods at floor level. The facility was utilizing several hundred cases of peel off mats per annum. They found that by switching to Polymeric floor coverings they witnessed a reduction in costs and an improvement in contamination control performance. They measured a 75% reduction in the level of airborne contaminants.

Competitiveness and Regulation: The FDA and the Future of America's Biomedical Industry
Posted: 02/22/2011
This report by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) highlights the critical role of the FDA in today's biomedical research and innovation ecosystem, and the need for a strong, science-based agency and an efficient, consistent and transparent regulatory process.

Compliance, Risk and Cost of Ownership Comparisons for Pharmaceutical Continuous Monitoring: Wired, Wireless and Standalone Monitoring Systems
Author: Ken Appel, Manager Regulated Markets, Veriteq, a Vaisala company
Posted: 02/03/2011
This white paper discusses five approaches to monitoring critical environments such as pharmaceutical freezers, stability rooms and warehouses. Quality, facility and IT managers employ different methods for maintaining the quality products and information. This paper and evaluates each the different methods and presents the risks and cost of ownership for each type.

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