A Cold Chain Process Validation Guide: Part 5: Operational Qualification (OQ) for Drug Products
Conducting a component qualification (CQ) and installation qualification (IQ) gives us a well-defined specification...
read DetailsExamines the effectiveness of simulated transport studies. This new study uses a holistic form of methodology testing the different hazards that arise in cold chain transport. In doing so, the “industry standards” of the following areas are questioned and tested.
Conducting a component qualification (CQ) and installation qualification (IQ) gives us a well-defined specification...
read DetailsRobust test standards and test methods must be in place in your quality management...
read DetailsDeveloping mature quality systems is one of the biggest challenges and one of the...
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