Displaying 76–100 of 309 results for USP

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Achieving Clean Pharmaceutical Water

(Article)

Controlling microbiological contamination is an ongoing process laden with risks. The best weapon against biofilm is prevention.

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

Metal Residue: How Much is Too Much?

(Article)

To comply with evolving guidelines, drug makers will need analytical and regulatory support

Particles in Parenterals: Regulatory and Compendial Considerations

(Article)

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

On-Line TOC: Will Marketing or Science Prevail?

(Article)

As new players enter the market and a standard is proposed to ASTM’s E-55 committee, a great deal of controversy is swirling around on-line TOC analysis for pharmaceutical-grade water. The world’s leading technical experts are aligned with one vendor or another, so it’s up to the user to filter ...

A Skeptic Remains

(Article)

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

Automating Microscope-Based Particle Counting

(Article)

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

Dissolution Testing in the 21st Century

(Article)

The Hot Topic session on dissolution testing at the recent AAPS Annual Meeting put PAT expert Ajaz Hussain on the hot seat in a debate over the applicability of a "testing tablet" to determining the stability of a solid dosage form.

Outsourcing: Look at the Long Term Risks vs. Benefits

(Article)

The Heparin case provides an excellent opportunity to use risk analysis, as defined in ICH Q9,to look at the costs of outsourcing manufacturing to China.

Unpacking the Complexity of Biologic Drug Containment

(Article)

Thinking differently about material selection and system integration for biologics

From the Editor: Quality Systems Lessons from NECC

(Article)

Is the risk of operating unsafely ever worth the short-term reward?

Stability Testing Meets QbD

(Article)

Contributing Editor Emil Ciurczak reports on the recent AAPS-sponsored conference, “Pharmaceutical Stability Testing to Support Global Markets.” Co-sponsored by CHPA, EAS, GPhA and PhRMA, the event was held Sept. 10-12 in Bethesda, Md.

From the Editor: There’s Room for All at the Table — Isn’t There?

(Article)

Should any single group have a monopoly on science-based standards?

Moheb Nasr on Heparin’s Lessons

(Article)

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

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.

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.

On the Cusp of Change

(Article)

Parenteral drug manufacturers are sharpening capabilities and coming into their own

SMB Takes On Paclitaxel Purification

(Article)

Therapeutic Dose: Avoiding "Cool Hand Luke" Syndrome: Part II

(Article)

At a time when the amount of available data is increasing exponentially, why are we isolating ourselves from our brethren and the larger scientific community?

Therapeutic Dose: Wishing Won’t Make It So

(Article)

A new generation of scientists and engineers will be needed to make PAT and QbD a reality, both within companies and regulatory agencies. Training will be the key.

The 2007 Team of the Year Finalists

(Article)

This year's Team of the Year finalists are collaborating with partners, opening dialogue between FDA and industry and improving process understanding at their facilities.

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

(Article)

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.

Life Science Level Measurement: An Update

(Article)

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

Framework for Fast Microbiological Assessment

(Article)

Encyclopedia of Rapid Microbiological Methods, Volume 4: The Next Generation of Rapid Method Applications, Validation Strategies and Regulatory Acceptance

Beyond SOPs

(Article)

The dependence of pharmaceutical development and manufacture on robust analytical data intensifies the need for rigor in analytical method development and increasingly a QbD approach — Analytical QbD (AQbD) — is seen as the way forward.

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