Displaying 76–100 of 156 results for USP

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Therapeutic Dose: Residual Solvents and a Trace of Cooperation

(Article)

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

USP Presents Heparin Quality Standards

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Small but necessary steps towards new and improved standards

Anticounterfeiting the Focus of USP Science Meeting

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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 ...

Ensuring ROI from Your RMM

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If you’re heading towards the adoption of rapid microbial methods, you’ve got to be able to make a business case.

USP Updates and for Microbial Testing of Non-Steriles

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

Best Practices for Cancer APIs

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Ash Stevens shares information gained from years in the business, and how it will make a new CMC alliance work with various partners.

USP Updates and for Microbial Testing of Non-Steriles

(Article)

Significant changes include more clarity on enumberation and specified organisms

Pumps Hit Their Prime

(Article)

OEMs continue to improve technologies for moving and dispensing liquids and other sensitive products, but manufacturers often fail to do due diligence in selecting the right technology.

Will Pharma Ditch the Dish?

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Rapid Microbial Methods (RMM) are gaining acceptance, but traditional microbiological testing, and the classic Petri dish, promise to be around for years to come.

From Drinks to Drugs: A Proposal for Advancing Aseptic Processing and ...

(Article)

The status quo in the beverage industry provides a glimpse at what the future of pharmaceutical aseptic processing could be.

Pharma’s Evolving Quality Systems: Views from ASQ’s National Director, Donald...

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The Malcolm Baldrige National Quality Award Examiner, certified specialist microbiologist and Six Sigma Green Belt recently shared his views on where the industry is heading and what it needs to improve.

Interphex Stands Test of Time (and Economy)

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Despite a tough economy, few question the value of attending Interphex, and this year’s show promises to be as good as ever.

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.

The Third Way for ICH Q7A: A Proposal for Updating Guidance for API Inspections

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There are not just two choices for API analysis—“old time” wet tests or super-sophisticated science-based tests—but also a third way. a combination of on-site qualification and use of targeted PAT equipment.

Jim Akers Knows Your Dirty Secrets

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We’re on the cusp of an aseptic processing sea change, Akers says, and you are to thank for it.

ICH Guidances (Already) Show Their Age

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ICH guidelines can be powerful tools for PAT/QbD, but some, such as ICH Q2 (R1), need updating.

Digital Insights: Exclusive Content? I Do.

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The Global Supply-Chain: Or, Which Shell is the Pea Under?

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There are solutions to making raw materials safer, but they involve coordinated technology and efforts.

Contractor Corner: Microtest’s Supply in Command

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A mid-size CMO knows from where its raw materials come, and continues to grow.

USP Tests to be Updated

(Article)

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

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.

Lessons from Heparin

(Article)

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

Moheb Nasr on Heparin’s Lessons

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The FDA’s lead scientist on the heparin case recounts the challenges and learnings from a very eventful year.

A Skeptic Remains

(Article)

Loyola University’s Dr. Jawed Fareed believes further heparin studies need to be done lest the past repeat itself

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.

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