Displaying 51–75 of 157 results for USP
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.
In the life of any drug product, the technology transfer of a process is a complex matter, made more complicated by the new definition of the Process Validation (PV) guidance issued by FDA in January 2011.
Until we can examine every supplier of excipient and API, well need to do our own detective work, but that will help us with Quality by Design.
As legislators and the courts re-examine an old fashioned word, sins of omission will count as much, if not more, than sins of commission.
Enforcing existing laws is a start.
Pharma Tech Industries Preston Wright talks about the need to move to a consistent quality presence that is both efficient and effective.
At look at how HACCP and FMEA can make a difference in the pharma micro lab.
Rapid microbiological methods continue to be developed in order to support or supplant compendial methods.
Is an overly rigid FDA causing today's chronic drug shortages? Or is it an industry that still struggles to meet the most basic quality standards?
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.
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.
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.
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.
Within the past five years, more of world's regulatory agencies and pharmacopeias have gotten on the same wavelength.