Displaying 51–75 of 157 results for USP

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

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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 ...

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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.

Therapeutic Dose: Protecting Pharma's Supply Chain

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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.

From the Editor: Adulteration, 21st Century Style

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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.

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

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Enforcing existing laws is a start.

Quality: Toward a Multidimensional View

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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

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

RMM Roundup: A Focus on Fast

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

Afnan: Drug Shortages and Accountability

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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?

Life Science Level Measurement: An Update

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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, ...

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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

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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.

Tracking Substandard Medicines; USP, FDA to Evaluate OTC Drugs

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

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

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Saving money through outsourcing is really starting to cost us.

The New Microbiological Technology Wave

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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

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

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

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

Automating Particulate Inspection: More Than Meets the Eye

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

Therapeutic Dose: Houses Built on Sand

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

Pharma Water Everywhere, but Little Consistent Guidance

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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

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

QbD for Better Method Validation and Transfer

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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

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

Rapid Sterility Testing: A Comparison to the Compendial Method

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

Taking the Plunge to Harmonize Pharmaceutical Regulations

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Within the past five years, more of world's regulatory agencies and pharmacopeias have gotten on the same wavelength.

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