Displaying 101–125 of 156 results for USP
ASPEX Corp. draws from its experience in other industries to provide an automated characterization solution for pharma.
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.
Does outsourcing manufacturing to nations with evolving GMPs make economic sense? As FDA, USP and other organizations continue to study the heparin case, we promise to keep you informed.
Benefits to a service contract are often seen during validation and the Factory Acceptance Test. Contract partners can also help optimize spare parts maintenance.
Should any single group have a monopoly on science-based standards?
Standards will help establish for diagnostics what USP monographs do for drug safety: An interview with Critical Path President/CEO Dr. Raymond Woosley.
Single-use process containers, assemblies and separation tools are helping bioprocessors make a smooth transition from stainless steel.
Italian drug maker Abiogen Pharma S.p.A. has succeeded in saving time and money as a result of applying near-infrared spectroscopy to raw materials characterization.
(Financial pressures + regulatory changes) = new manufacturing paradigm (- breadth of experience + narrow focus) = problems achieving Quality by Design.
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.
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.
Controlling microbiological contamination is an ongoing process laden with risks. The best weapon against biofilm is prevention.
Isolators have allowed Bayer Healthcares Shawnee, Kansas facility to run for three years without a single false positive.
Interest in these products is surging, but unique regulatory issues make them challenging.
Italian drug company Abiogen Pharma has significantly boosted productivity, saved time on analysis and reduced instrument and chemical costs by implementing NIR spectroscopy to characterize incoming raw materials.
Using NIR to measure absorbance at significant wavelengths for the granule and lubricant as the blend proceeded in real time, the authors found a relationship between blend uniformity and the standard deviation of the absorbance.
Agency leaders are redefining science, moving away from early 20th century empiricism and toward a mechanistic understanding of processes, in everything from manufacturing to R&D and clinical trials.
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.
Emil Ciurczak met with Gary Ritchie at the 2007 IFPAC conference to discuss the latest in standards development for process analytical technologies (PAT) at USP. Listen to the interview or read the transcript here.
In this interview with Emil Ciurczak during IFPAC, Dr. Chris Watts discusses pharma PAT and where it is going, within FDA and the industry.
In these audio files, hot off the wire from the 2007 IFPAC Conference, Process Analytical Technologies expert Emil Ciurczak interviews leading PAT authorities from USP, FDA and the pharmaceutical industry.
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 ...
Robust analytical TOC method validation is essential to the success of any on-line TOC system, particularly systems that release pharmaceutical-grade water in real time. Meeting USP 643 or EP 2.2.44 specifications may not eliminate risk.
The U.S. Pharmacopeia's program is designed to assure manufacturers, regulatory authorities and consumers that drug substances and excipients bearing the USP Program Mark are of consistent, high quality.
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.