Displaying 26–50 of 156 results for USP

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IFPAC 2016 Conference

(Article)

Neither rain, nor sleet, nor snow could keep me from finding the lastest technology at IFPAC 2016 conference.

Quality Control with Handheld Raman

(Article)

Ensuring compliance for raw material identification is easily within reach

Inside 2015 Endotoxin Testing

(Article)

Why LER is here to stay, the need to safeguard test supply, revisiting the definition of alternative assays, and moving toward automation

No Man’s Land

(Article)

Humans invading your sterile processes? Advances in aseptic processing technologies aim to keep their risk and contamination at bay.

Bioreactor Preferences from an Outsourcing Perspective – Part I

(Article)

Drug Owners and CMOs both have skin in the game when it comes to specifying bioreactor technology

Applying Single-Use Efficiencies to Room-to-Room Fluid Transfer

(Article)

Fewer headaches, reduced complexity and flexibility come with the territory

Good Vibrations

(Article)

The advantages of near-infrared spectroscopy in pharmaceutical analysis

A Case for Stage 3 Continued Process Verification

(Article)

Reducing process related failures and quality costs; Continued Process Verification can improve control and lower failure rates

USP Microbial Examination of Non-Sterile Products

(Article)

A road map to the world of non-sterile testing regulations

Meeting Global Pharmacopeia Requirements for Water Compliance

(Article)

By understanding feedwater and the water purification system, a consistent supply of Purified Water, Highly Purified Water or Water for Injection can be ensured.

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.

Vials vs. Dual-Chamber Systems

(Article)

For freeze-dried drugs, packaging makes the difference

Better Data, Better Solid Dose QbD

(Article)

Newer monitoring technologies can provide real insight into solid-dose forms in process

CMOs Share Their Secrets to Success

(Article)

A virtual panel of four contract manufacturing organization thought leaders shares what it takes to be competitive in today’s challenging market

Metal Residue: How Much is Too Much?

(Article)

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

Ozone: A New Water Management Paradigm

(Article)

Producing and sanitizing pharmaceutical water isn’t easy — but there are options for doing both less expensively

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

From the Editor: Quality Systems Lessons from NECC

(Article)

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

Therapeutic Dose: Enemies Within

(Article)

FDA’s hard pressed to inspect offshore facilities; now it also faces compounders and other domestic challenges.

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?

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.

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