Displaying 76–100 of 309 results for USP
Controlling microbiological contamination is an ongoing process laden with risks. The best weapon against biofilm is prevention.
Just as process validation can benefit from a QbD and a product lifecycle approach, so can analytical method validation and transfer
To comply with evolving guidelines, drug makers will need analytical and regulatory support
Pfizers John Shabushnig shares insights into burning compendial and regulatory issues.
As new players enter the market and a standard is proposed to ASTMs E-55 committee, a great deal of controversy is swirling around on-line TOC analysis for pharmaceutical-grade water. The worlds leading technical experts are aligned with one vendor or another, so its up to the user to filter ...
Loyola Universitys Dr. Jawed Fareed believes further heparin studies need to be done lest the past repeat itself
New methods add speed and accuracy to the traditional challenge of counting particles in various pharmaceutical applications.
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.
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.
Thinking differently about material selection and system integration for biologics
Is the risk of operating unsafely ever worth the short-term reward?
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.
Should any single group have a monopoly on science-based standards?
The FDAs lead scientist on the heparin case recounts the challenges and learnings from a very eventful year.
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 counters present clear opportunities for pharma, but also unique challengesamong them, the need to update regulatory guidance for Rapid Microbiological Methods.
Parenteral drug manufacturers are sharpening capabilities and coming into their own
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?
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.
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.
There are not just two choices for API analysisold time wet tests or super-sophisticated science-based testsbut also a third way. a combination of on-site qualification and use of targeted PAT equipment.
What was once a laborious process is getting easier, thanks to modern sensors and calibration procedures.
Encyclopedia of Rapid Microbiological Methods, Volume 4: The Next Generation of Rapid Method Applications, Validation Strategies and Regulatory Acceptance
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.