Displaying 26–50 of 309 results for USP

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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.

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

(Article)

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

(Article)

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.

News: FDA-USP Workshop Previews Updated OTC Quality Standards

(News)

CDER Director Dr. Janet Woodcock Will Keynote Workshop, Modernized Standards to have Broad Patient, Industry Impact

Hospira Recalls One Lot of Sodium Bicarbonate Injection

(News)

Due to the presence of a particulate, Hospira is voluntarily recalling one lot of 8.4% Sodium Bicarbonate Injection, USP

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.

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 ...

Baxter Recalls Select Lots of Injectables

(News)

Baxter International Inc. announced on December 23 thatit has initiated a voluntary recall to the hospital/user level of one lot of 5% Dextrose Injection, USP and four lots of 0.9% Sodium Chloride Injection, USP due to particulate matter found in the solutions.

EpiPen Competitor Coming Soon from Kaleo

(News)

AUVI-Q (epinephrine injection, USP) auto-injector will enter the U.S. market in the first half of 2017

Mylan Launches First Generic of Doryx for Acne Treatment

(News)

The company announced the U.S. launch of Doxycycline Hyclate Delayed-Release (DR) Tablets USP, 50 mg

Mettler-Toledo Thornton

(Product)

The new System Suitability Standards Set from Mettler-Toledo Thornton provides the reference standard solutions necessary to perform testing for the 5000TOC Sensor in conformance with USP (643) and EP 2.2.44.

Exploring Advances in Conductivity Technology

(Whitepaper)

This executive summary from GE Analytical Instruments discusses an advancement in Conductivity analysis technology that can significantly reduce the time spent to comply with the USP <645> regulation.

ANATEL TOC600 Online Total Organic Carbon Analyzer

(Whitepaper)

ANATEL TOC analyzers are the industry standard for purified water and ultrapure water. The ANATEL TOC600 provides online TOC analysis for a range of applications requiring USP Chapter <643> and EP Chapter 2.2.44 for TOC requirements, as well as USP Chapter <645> for conductivity measurement. The ...

Particle Counting in Injectable Solutions

(Whitepaper)

This paper, by Particle Measuring Systems, in its third revision, discusses the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards and includes the most recent USP 788 (April 2007), EP 5.1 and JP 15 release information. These standards demand that ...

ANATEL PAT700

(Whitepaper)

The ANATEL PAT700 is a science and risk-based on-line TOC analyzer that simplifies the application of process analytical technology in life science water system applications. Designed as a fully compliant TOC analyzer that meets the requirements of USP <643> and EP 2.2.44 for TOC, USP <645> and ...

ANATEL A643a Total Organic Carbon (TOC) Analyzer

(Whitepaper)

The ANATEL A643a offers reliable, robust performance in water system-critical TOC monitoring. Designed specifically to meet the needs of the pharmaceutical market, the ANATEL A643a is fully compliant with industry methods including USP<643> and <645>, EP 2.2.44 and JP XV<60>. With a number of key...

HIAC 9705 Liquid Particle Counting System

(Whitepaper)

HIAC quality and reliability take new shape in the 9705, with exciting developments in liquid particle sampling technology. An innovative sampling process, housed within the 9705’s streamlined case, provides consistent dispersion and highly pure sampling. The 9705 sets new standards for accuracy ...

Fact or Fiction: Automated Dissolution Testing Reduces Operator Error and ...

(Whitepaper)

While the automation of dissolution testing is primarily touted as a means to reduce operator bench time, the reduction in operator error is often overlooked. In fact, many pessimists argue that the calibration and service hours associated with automation negate the overall reduction in operator ...

USP Acceptable TOC Levels for Pharmaceutical Water: How to Achieve Them?

(Whitepaper)

Meeting the regulations and validation rules is an important task for the pharmaceutical industry. In order to be compliant with the regulations and meet the required quality and safety standards, the pharmaceutical industry must develop economical and competitive production and cleaning methods,...

USP acceptable TOC levels for pharmaceutical water: How to achieve them?

(Whitepaper)

Compliance with acceptable TOC levels in pharmaceutical water regulations must be maintained within the pharmaceutical industry throughout different manufacturing processes. This white paper attempts to classify these necessary regulations and compliance through preparation, production and waste ...

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 ...

Examining the Role of TOC Analyzers in the Pharmaceutical Laboratory

(Whitepaper)

Total Organic Carbon (TOC) analyzers serve a vital role in the pharmaceutical lab, in both the drug development and manufacturing processes. Presented here is an overview, as well as application examples showcasing TOC for Cleaning Validation and to address such guidelines as USP <643>.

Examining the Role of TOC Analyzers in the Pharmaceutical Laboratory

(Whitepaper)

Total Organic Carbon (TOC) analyzers serve a vital role in the pharmaceutical lab, in both the drug development and manufacturing processes. Presented here is an overview, as well as application examples showcasing TOC for Cleaning Validation and to address such guidelines as USP <643>.

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

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