What should you be aware of before starting instrument qualification, and what can an instrument provider do to help you avoid the hidden costs of GMP qualification?
We look into how the pharma analysis & QC community envisions future trends and explore if the challenges faced by your peers are the same as yours.
Learn how rapid detection methods allow you to address contamination events sooner, avoid line shutdowns, release product to the market faster, and reduce warehousing costs.
Explore how a small or medium size biotech or pharma company eveloping sterile injectables can benefit from the experience and assistance provided by a CDMO.
There are quite a few applications that require multiple streams to converge into a single process flow. Two such examples are buffer formulation and liquid chromatography gradient elution.
Here we review the information in European Pharmacopoeia (EP) General Chapter 5.1.2, concerning BIs, which is more detailed and covers a wider scope than the previous version.
We review what to do should you ever find yourself in the situation where the probes indicate conditions that would render killed BIs, yet the units are testing positive.
Phase 1 investigational drugs are exempt from the requirements of the current good manufacturing practices (cGMP), as prescribed in Title 21 of the Code of Federal Regulations parts 210 and 211.
Whether it's a liquid or lyophilized product, we provide capacity, quality, and expertise to ensure a stable supply of your promising therapeutics.
Raman spectroscopy is used to compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world, all containing the same API.
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