Displaying 101–125 of 318 results for USP
CDER Director Dr. Janet Woodcock Will Keynote Workshop, Modernized Standards to have Broad Patient, Industry Impact
What was once a laborious process is getting easier, thanks to modern sensors and calibration procedures.
Last month in Bethesda, at a conference on the Current Challenges of GMPs, presented by Pharma Conference, Inc., FDA officials took FDAs transparency mandate to new levels, by discussing some of the issues they are seeing at pharmaceutical manufacturing and quality operations.
As PTFE diaphragms are subjected to more aggressive sterilization and cooling conditions, they are more prone to failure from cracking, splitting, deformation and SIP steam-induced blisters.
Value Plastics Expands Press-In Plug Line
Sartorius Stedim Biotech Launches UniVessel SU Single-Use Bioreactor for Small-Scale Cell Culture Applications
The PQM program has launched a new public database of medicines collected and analyzed.
Saving money through outsourcing is really starting to cost us.
In an excerpt from an important new book, Pfizer's Claudio Denoya looks at alternative microbiological methods, and their connection with process analytical technology (PAT).
Pfizers John Shabushnig shares insights into burning compendial and regulatory issues.
Economically-motivated adulteration is one of many issues that industry, and USP, is tackling
Since operators are fallible and low-throughput, manufacturers must automate inspection of visible particulates.
Our foundations for Quality by Design are of poor quality, yet industry and FDA continue to let things slide.
Thermo Scientific TruScan is a rugged, handheld system for rapid material verification. On-the-spot results are delivered in seconds with nondestructive point-and shoot sampling through sealed packaging. TruScan reduces the need for quarantine areas and staging of raw materials, while minimizing ...
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.
New methods add speed and accuracy to the traditional challenge of counting particles in various pharmaceutical applications.
ATMI: Ultra-Clean 2-D and 3-D Bioprocess Vessels for Integrity Single-Use Product Line
Chata Biosystems: Alternative Purified Water Supply
Just as process validation can benefit from a QbD and a product lifecycle approach, so can analytical method validation and transfer
Why can't QbD be, literally, as easy as pie?
Dawn McIver of MicroWorks, Inc., discusses studies that she has done comparing traditional compendial methods of microbiological testing.
USP has re-evaluated the currently available Prednisone RS Tablets Lot P0E203 and established new acceptance criteria based on a whole-assembly geometric mean and standard deviation approach rather than the individual-position (per tablet) approach.