The tripartite International Conference on Harmonisation (ICH) Q2 guide on validation of analytical procedures is not new, but it can give very good advice when validating laboratory Total Organic ...
DUBLIN, Aug. 28, 2019 /PRNewswire/ -- The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added ...
Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...
Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...
Temperature gradient was first used to identify the methylation status of the DNA sequence over 10 years ago; however, the initially published protocol was shown to have poor analytical sensitivity.
The IAEA Environmental Laboratories produce certified reference materials for the measurement of radionuclides, trace elements and organic contaminants. These materials can be used for quality ...
Analytical procedures have increasingly become important when conducting audit on financial statements. This has been shown by the Auditing Standards Board, which made it compulsory to perform ...
The Food & Drug Administration's recent approval of process analytical technology (PAT) for use in the pharmaceutical industry is being hailed by drug manufacturers because it encourages process ...
Typical questions that arise include, why is it necessary to qualify analytical instruments in such environments? Why do titrando or OMNIS systems need such a service? Here, the safety of consumers is ...
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