Displaying 101–125 of 157 results for USP

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On Transforming Pharmaceutical Technology Education

(Article)

A looming crisis in the availability of qualified graduates signals the need for a paradigm shift in pharmaceutical technology education.

Particle Analysis for the QbD Era

(Article)

ASPEX Corp. draws from its experience in other industries to provide an automated characterization solution for pharma.

Outsourcing: Look at the Long Term Risks vs. Benefits

(Article)

The Heparin case provides an excellent opportunity to use risk analysis, as defined in ICH Q9,to look at the costs of outsourcing manufacturing to China.

Outsourcing: Cost versus Benefit

(Article)

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.

Outsourcing Biopharma Water Treatment

(Article)

Benefits to a service contract are often seen during validation and the Factory Acceptance Test. Contract partners can also help optimize spare parts maintenance.

From the Editor: There’s Room for All at the Table — Isn’t There?

(Article)

Should any single group have a monopoly on science-based standards?

Critical Path to Establish Performance Test Standards for Diagnostics

(Article)

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

Disposables: Increasingly Indispensable

(Article)

Single-use process containers, assemblies and separation tools are helping bioprocessors make a smooth transition from stainless steel.

Leaning on NIR in Pisa

(Article)

Italian drug maker Abiogen Pharma S.p.A. has succeeded in saving time and money as a result of applying near-infrared spectroscopy to raw materials characterization.

Therapeutic Dose: The Perfect Storm

(Article)

(Financial pressures + regulatory changes) = new manufacturing paradigm (- breadth of experience + narrow focus) = problems achieving Quality by Design.

Stability Testing Meets QbD

(Article)

Contributing Editor Emil Ciurczak reports on the recent AAPS-sponsored conference, “Pharmaceutical Stability Testing to Support Global Markets.” Co-sponsored by CHPA, EAS, GPhA and PhRMA, the event was held Sept. 10-12 in Bethesda, Md.

The 2007 Team of the Year Finalists

(Article)

This year's Team of the Year finalists are collaborating with partners, opening dialogue between FDA and industry and improving process understanding at their facilities.

Achieving Clean Pharmaceutical Water

(Article)

Controlling microbiological contamination is an ongoing process laden with risks. The best weapon against biofilm is prevention.

Minimizing Risk in Sterilization Validation

(Article)

Isolators have allowed Bayer Healthcare’s Shawnee, Kansas facility to run for three years without a single false positive.

Combination Products: Navigating Two FDA Quality Systems

(Article)

Interest in these products is surging, but unique regulatory issues make them challenging.

Using NIR Spectroscopy for Raw Materials Characterization

(Article)

Italian drug company Abiogen Pharma has significantly boosted productivity, saved time on analysis and reduced instrument and chemical costs by implementing NIR spectroscopy to characterize incoming raw materials.

Introducing PAT, Using NIR Analysis, to a Pharmaceutical Blending Process

(Article)

Using NIR to measure absorbance at significant wavelengths for the granule and lubricant as the blend proceeded in real time, the authors found a relationship between blend uniformity and the standard deviation of the absorbance.

FDA Sets Its House in Order

(Article)

Agency leaders are redefining science, moving away from early 20th century empiricism and toward a mechanistic understanding of processes, in everything from manufacturing to R&D and clinical trials.

Therapeutic Dose: Wishing Won’t Make It So

(Article)

A new generation of scientists and engineers will be needed to make PAT and QbD a reality, both within companies and regulatory agencies. Training will be the key.

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

(Article)

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.

FDA's Chris Watts on New Directions for PAT at FDA

(Article)

In this interview with Emil Ciurczak during IFPAC, Dr. Chris Watts discusses pharma PAT and where it is going, within FDA and the industry.

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.

On-Line TOC: Will Marketing or Science Prevail?

(Article)

As new players enter the market and a standard is proposed to ASTM’s E-55 committee, a great deal of controversy is swirling around on-line TOC analysis for pharmaceutical-grade water. The world’s leading technical experts are aligned with one vendor or another, so it’s up to the user to filter ...

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.

Inside USP’s New Pharmaceutical Ingredient Verification Program

(Article)

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.

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