Displaying 76–100 of 156 results for USP
The new guidelines are evidence of multinational law enforcement at its best.
Small but necessary steps towards new and improved standards
At the USP Science Meeting in Toronto last week, the topic of anticounterfeiting and assuring drug quality took center stage. A number of presentations addressed the use of analytical technologies to protect public health. Raman spectroscopy appears to be gaining use to help detect fakes in the ...
If youre heading towards the adoption of rapid microbial methods, youve got to be able to make a business case.
The United States Pharmacopeia (USP) has significantly changed the USP XXXI <61> Microbial Limits Test, updating it and dividing it into two parts
Ash Stevens shares information gained from years in the business, and how it will make a new CMC alliance work with various partners.
Significant changes include more clarity on enumberation and specified organisms
OEMs continue to improve technologies for moving and dispensing liquids and other sensitive products, but manufacturers often fail to do due diligence in selecting the right technology.
Rapid Microbial Methods (RMM) are gaining acceptance, but traditional microbiological testing, and the classic Petri dish, promise to be around for years to come.
The status quo in the beverage industry provides a glimpse at what the future of pharmaceutical aseptic processing could be.
The Malcolm Baldrige National Quality Award Examiner, certified specialist microbiologist and Six Sigma Green Belt recently shared his views on where the industry is heading and what it needs to improve.
Despite a tough economy, few question the value of attending Interphex, and this years show promises to be as good as ever.
USPs Drug Quality and Information Program is establishing training programs around the world. Its Madagascar program offers a model.
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.
Were on the cusp of an aseptic processing sea change, Akers says, and you are to thank for it.
ICH guidelines can be powerful tools for PAT/QbD, but some, such as ICH Q2 (R1), need updating.
Were committed to keeping you engaged
There are solutions to making raw materials safer, but they involve coordinated technology and efforts.
A mid-size CMO knows from where its raw materials come, and continues to grow.
Emil Ciurczak talks with Bill Cook, Chief Metrology Officer, and Darrell Abernethy, Chief Science Officer, USP
An interview with Patrick Lukulay, Director of USPs Drug Quality and Information Program, a grant-funded program funded by US AID with the goal of strengthening QA and QC in developing countries. The program is now working in Africa, Latin America and Southeast Asia.
Avoiding future drug quality disasters will require closer control over raw materials, use of more powerful analytics and IT, and a Quality by Design approach
The FDAs lead scientist on the heparin case recounts the challenges and learnings from a very eventful year.
Loyola Universitys Dr. Jawed Fareed believes further heparin studies need to be done lest the past repeat itself
A looming crisis in the availability of qualified graduates signals the need for a paradigm shift in pharmaceutical technology education.