Displaying 26–50 of 156 results for USP
Neither rain, nor sleet, nor snow could keep me from finding the lastest technology at IFPAC 2016 conference.
Ensuring compliance for raw material identification is easily within reach
Why LER is here to stay, the need to safeguard test supply, revisiting the definition of alternative assays, and moving toward automation
Humans invading your sterile processes? Advances in aseptic processing technologies aim to keep their risk and contamination at bay.
Drug Owners and CMOs both have skin in the game when it comes to specifying bioreactor technology
Fewer headaches, reduced complexity and flexibility come with the territory
The advantages of near-infrared spectroscopy in pharmaceutical analysis
Reducing process related failures and quality costs; Continued Process Verification can improve control and lower failure rates
A road map to the world of non-sterile testing regulations
By understanding feedwater and the water purification system, a consistent supply of Purified Water, Highly Purified Water or Water for Injection can be ensured.
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.
For freeze-dried drugs, packaging makes the difference
Newer monitoring technologies can provide real insight into solid-dose forms in process
A virtual panel of four contract manufacturing organization thought leaders shares what it takes to be competitive in todays challenging market
To comply with evolving guidelines, drug makers will need analytical and regulatory support
Producing and sanitizing pharmaceutical water isnt easy but there are options for doing both less expensively
Encyclopedia of Rapid Microbiological Methods, Volume 4: The Next Generation of Rapid Method Applications, Validation Strategies and Regulatory Acceptance
Is the risk of operating unsafely ever worth the short-term reward?
FDAs hard pressed to inspect offshore facilities; now it also faces compounders and other domestic challenges.
Can standardization and innovation coexist?
Why are we so comfortable following draft guidanceFDAs unfinished and incomplete current thinking?
FDAs John Kauffman describes the vast potential of portable Raman devices, even for those who are not trained spectroscopy experts.
Efforts to enact meaningful standards for single-use bioprocessing technologies move at a snail's pace, with no clear path forward, experts say.
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.