Displaying 76–100 of 308 results for USP

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Gemu: Aseptic Globe Valves

(Product)

Gemu: Aseptic Globe Valves

PharmaView: Single-Use Standards: What’s the Rush?

(Article)

Can standardization and innovation coexist?

FDA, Revisit Your Sampling Guidance!

(Article)

Why are we so comfortable following draft guidance—FDA’s unfinished and incomplete current thinking?

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>.

A New Era in Handheld Raman Devices for Pharmaceutical Applications

(Article)

FDA’s John Kauffman describes the vast potential of portable Raman devices, even for those who are not trained spectroscopy experts.

Are Single-Use Standards Stuck? And Is That a Bad Thing?

(Article)

Efforts to enact meaningful standards for single-use bioprocessing technologies move at a snail's pace, with no clear path forward, experts say.

Real-Time Viable Particle Detection: Benefits, Challenges, and Regulatory Needs

(Article)

Real-time viable particle counters present clear opportunities for pharma, but also unique challenges—among them, the need to update regulatory guidance for Rapid Microbiological Methods.

A Framework for Technology Transfer to Satisfy the Requirements of the New ...

(Article)

In the life of any drug product, the technology transfer of a process is a complex matter, made more complicated by the new definition of the Process Validation (PV) guidance issued by FDA in January 2011.

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>.

Colder: Single-Use Sterile Connectors designed for greater process flexibility

(Product)

Colder: Single-Use Sterile Connectors designed for greater process flexibility

Value Plastics: Bag Port Technology to Transfer Media and Drug Compounds

(Product)

Value Plastics: Bag Port Technology to Transfer Media and Drug Compounds

Colder Products: AseptiQuik STC provides flexibility for hybrid stainless and...

(Product)

Colder Products: AseptiQuik STC provides flexibility for hybrid stainless and single use systems

Terracon: TerraPro Polypropylene Tanks for WFI Applications

(Product)

Terracon: Terrapro Polypropylene Tanks for Water for Injection Applications

Therapeutic Dose: Protecting Pharma's Supply Chain

(Article)

Until we can examine every supplier of excipient and API, we’ll need to do our own detective work, but that will help us with Quality by Design.

Pall Corp.: Mustang XT Acrodisc Ion Exchange Chromatography Units for ...

(Product)

Pall Corp.: Mustang XT Acrodisc Ion Exchange Chromatography Units for Laboratory Use and Process Development

From the Editor: Adulteration, 21st Century Style

(Article)

As legislators and the courts re-examine an old fashioned word, sins of omission will count as much, if not more, than sins of commission.

B&W Tek Introduces Next Generation Handheld Raman Instrument for Material ...

(Product)

B&W Tek Introduces Next Generation Handheld Raman Instrument for Material Verification in cGMP Compliant Facilities

Therapeutic Dose: Problems in Pharma? Time to Examine the Rules

(Article)

Enforcing existing laws is a start.

Quality: Toward a Multidimensional View

(Article)

Pharma Tech Industries’ Preston Wright talks about the need to move to a “consistent quality presence that is both efficient and effective.”

Risk Management in Pharmaceutical Microbiology

(Article)

At look at how HACCP and FMEA can make a difference in the pharma micro lab.

RMM Roundup: A Focus on Fast

(Article)

Rapid microbiological methods continue to be developed in order to support or supplant compendial methods.

Afnan: Drug Shortages and Accountability

(Article)

Is an overly rigid FDA causing today's chronic drug shortages? Or is it an industry that still struggles to meet the most basic quality standards?

Focus on Pharma Episode 20: FDA and USP Collaborate to Update Standards for ...

(Multimedia)

A September workshop sponsored by FDA and USP will examine progress in modernizing analytical methods and test procedures, to help prevent adulterated over-the-counter medications from reaching the public. Impurities testing and material identification will be critical. Both Agencies summarized ...

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

Life Science Level Measurement: An Update

(Article)

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

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