Displaying 101–125 of 309 results for USP

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Life Science Level Measurement: An Update

(Article)

What was once a laborious process is getting easier, thanks to modern sensors and calibration procedures.

FDA Fields Tough Questions About Inspections, Challenges Pharma to Be Open, ...

(Article)

Last month in Bethesda, at a conference on the Current Challenges of GMPs, presented by Pharma Conference, Inc., FDA officials took FDA’s transparency mandate to new levels, by discussing some of the issues they are seeing at pharmaceutical manufacturing and quality operations.

Maintaining Integrity: Effects of SIP Sterilization on PTFE Valve Diaphragms

(Article)

As PTFE diaphragms are subjected to more aggressive sterilization and cooling conditions, they are more prone to failure from cracking, splitting, deformation and SIP steam-induced blisters.

Value Plastics Expands Press-In Plug Line

(Product)

Value Plastics Expands Press-In Plug Line

Sartorius Stedim Biotech Launches UniVessel SU Single-Use Bioreactor for ...

(Product)

Sartorius Stedim Biotech Launches UniVessel SU Single-Use Bioreactor for Small-Scale Cell Culture Applications

Tracking Substandard Medicines; USP, FDA to Evaluate OTC Drugs

(Article)

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

April 2011

Therapeutic Dose: It Seemed Like a Good Idea at the Time

(Article)

Saving money through outsourcing is really starting to cost us.

The New Microbiological Technology Wave

(Article)

In an excerpt from an important new book, Pfizer's Claudio Denoya looks at alternative microbiological methods, and their connection with process analytical technology (PAT).

Particles in Parenterals: Regulatory and Compendial Considerations

(Article)

Pfizer’s John Shabushnig shares insights into burning compendial and regulatory issues.

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

(Article)

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

Automating Particulate Inspection: More Than Meets the Eye

(Article)

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

Therapeutic Dose: Houses Built on Sand

(Article)

Our foundations for Quality by Design are of poor quality, yet industry and FDA continue to let things slide.

Thermo Scientific TruScan Fast, Cost-Effective Method Development

(Whitepaper)

Thermo Scientific TruScan is a rugged, handheld system for rapid material verification. On-the-spot results are delivered in seconds with nondestructive point-and shoot sampling through sealed packaging. TruScan reduces the need for quarantine areas and staging of raw materials, while minimizing ...

Pharma Water Everywhere, but Little Consistent Guidance

(Article)

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.

Automating Microscope-Based Particle Counting

(Article)

New methods add speed and accuracy to the traditional challenge of counting particles in various pharmaceutical applications.

ATMI: Ultra-Clean 2-D and 3-D Bioprocess Vessels for Integrity Single-Use ...

(Product)

ATMI: Ultra-Clean 2-D and 3-D Bioprocess Vessels for Integrity Single-Use Product Line

Chata Biosystems: Alternative Purified Water Supply

(Product)

Chata Biosystems: Alternative Purified Water Supply

QbD for Better Method Validation and Transfer

(Article)

Just as process validation can benefit from a QbD and a product lifecycle approach, so can analytical method validation and transfer

Therapeutic Dose: Qbd: A Pinch of This and a Dash of That

(Article)

Why can't QbD be, literally, as easy as pie?

Rapid Sterility Testing: A Comparison to the Compendial Method

(Article)

Dawn McIver of MicroWorks, Inc., discusses studies that she has done comparing traditional compendial methods of microbiological testing.

USP Re-evaluates Dissolution Test Tablets, Methods

(News)

USP has re-evaluated the currently available Prednisone RS Tablets Lot P0E203 and established new acceptance criteria based on a whole-assembly geometric mean and standard deviation approach rather than the individual-position (per tablet) approach.

Scientific Exchange Program Promotes Collaborative Quality Standards for ...

(News)

To promote international scientific exchange and ultimately foster global harmonization of standards for medicines and food ingredients, scientists from around the world will join the U.S. Pharmacopeial Convention (USP) at its headquarters on a rolling basis throughout 2010. USP welcomed the ...

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