Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, ...
QC laboratories perform a critical role in demonstrating pharmaceutical products are consistently manufactured, safe, potent, and pure. At the same time, the number of tests run by QC laboratories is ...
Please note: This item is from our archives and was published in 2001. It is provided for historical reference. The content may be out of date and links may no longer function. uditors perform ...
Many assays have integrated, built-in, or internal controls to demonstrate their operability at specific procedural steps. What role do these built-in controls play in quality control to assure ...
DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to ...
Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.
Advanced Techniques of Analytical Chemistry explains analytical chemistry in an accessible manner for students. The book provides basic and practical knowledge that helps the learner to understand the ...
One of the quality characteristics defined in the European and USA pharmacopeias for pharmaceutical waters is Total Organic Carbon (TOC) 1. Contemporary water treatment systems are able to provide ...
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