Displaying 1–25 of 156 results for USP

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USP Updates and for Microbial Testing of Non-Steriles

(Article)

The United States Pharmacopeia (USP) has significantly changed the USP XXXI <61> Microbial Limits Test, updating it and dividing it into two parts

USP Tests to be Updated

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Emil Ciurczak talks with Bill Cook, Chief Metrology Officer, and Darrell Abernethy, Chief Science Officer, USP

USP's DeStefano on Defining, and Detecting, Pharmaceutical Impurities

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Economically-motivated adulteration is one of many issues that industry, and USP, is tackling

Inside USP’s New Pharmaceutical Ingredient Verification Program

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The U.S. Pharmacopeia's program is designed to assure manufacturers, regulatory authorities and consumers that drug substances and excipients bearing the “USP Program Mark” are of consistent, high quality.

USP's Gary Ritchie with an Update on PAT Standards Development

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Emil Ciurczak met with Gary Ritchie at the 2007 IFPAC conference to discuss the latest in standards development for process analytical technologies (PAT) at USP. Listen to the interview or read the transcript here.

Anticounterfeiting the Focus of USP Science Meeting

(Article)

At the USP Science Meeting in Toronto last week, the topic of anticounterfeiting and assuring drug quality took center stage. A number of presentations addressed the use of analytical technologies to protect public health. Raman spectroscopy appears to be gaining use to help detect fakes in the ...

Analyzing for Elemental Impurities

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Understanding new guidance from the USP so that you can determine which approach to adopt when performing elemental impurity analysis.

USP Microbial Examination of Non-Sterile Products

(Article)

A road map to the world of non-sterile testing regulations

USP Updates and for Microbial Testing of Non-Steriles

(Article)

Significant changes include more clarity on enumberation and specified organisms

Tracking Substandard Medicines; USP, FDA to Evaluate OTC Drugs

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The PQM program has launched a new public database of medicines collected and analyzed.

USP India’s New Facility Opens its Doors

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AstraZeneca India's former president oversees the operation, which includes a business office and testing laboratories.

Will USP and FDA Reach Consensus on Stability Testing?

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Editor in Chief Agnes Shanley observes that standards will guide drug manufacturing's future, if everyone can agree on what's important.

USP Presents Heparin Quality Standards

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Small but necessary steps towards new and improved standards

PAT in Perspective: Do We Need Final Release Tests with PAT?

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NIR expert Emil Ciurczak asks whether PAT will eliminate the need for traditional USP product release tests…and concludes that they’re still essential as a reference method and important in minimizing liability.

Stopping Counterfeits and Substandard Drugs

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An interview with Patrick Lukulay, Director of USP’s Drug Quality and Information Program, a grant-funded program funded by US AID with the goal of strengthening QA and QC in developing countries. The program is now working in Africa, Latin America and Southeast Asia.

Outsourcing: Cost versus Benefit

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Does outsourcing manufacturing to nations with evolving GMP’s make economic sense? As FDA, USP and other organizations continue to study the heparin case, we promise to keep you informed.

Global QC: On the Front Lines With DQI’s Patrick Lukulay

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USP’s Drug Quality and Information Program is establishing training programs around the world. Its Madagascar program offers a model.

Critical Path to Establish Performance Test Standards for Diagnostics

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Standards will help establish for diagnostics what USP monographs do for drug safety: An interview with Critical Path President/CEO Dr. Raymond Woosley.

Podcasts from IFPAC: "Radio Free Emil"

(Article)

In these audio files, hot off the wire from the 2007 IFPAC Conference, Process Analytical Technologies expert Emil Ciurczak interviews leading PAT authorities from USP, FDA and the pharmaceutical industry.

Validating On-Line TOC Analyzers for Real-Time Release

(Article)

Robust analytical TOC method validation is essential to the success of any on-line TOC system, particularly systems that release pharmaceutical-grade water in real time. Meeting USP 643 or EP 2.2.44 specifications may not eliminate risk.

Lessons from Heparin

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Avoiding future drug quality disasters will require closer control over raw materials, use of more powerful analytics and IT, and a Quality by Design approach

Q&A: Pharma's Evolving Packaging Systems

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With Pharma EXPO just two months away, Pharmaceutical Manufacturing discusses the challenges of today's quickly changing packaging systems with Jerry Martin, pharmaceutical and life sciences consultant to PMMI, The Association of Packaging and Processing Technologies.

Therapeutic Dose: Residual Solvents and a Trace of Cooperation

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The new guidelines are evidence of multinational law enforcement at its best.

Automating Particulate Inspection: More Than Meets the Eye

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Since operators are fallible and “low-throughput,” manufacturers must automate inspection of visible particulates.

IFPAC 2006 Under the Microscope

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"NIR person" and physical chemist Emil Ciurczak provides a thorough analysis of this year's IFPAC conference, held Feb. 21-23 in Arlington, Va.

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