process validation

Inspector at a laboratory or manufacturing plant

Assay Streamlining, Benefits and Drawbacks

As a biopharmaceutical company matures and new products are added to its portfolio, expansion of its facilities, systems and Quality Control is a natural outcome. The growth in the Quality Control...

Man looking at two arrows pointing in opposite direction

To Requalify or to Continuously Monitor, That is the Question

Your manufacturing equipment and processes have been established, qualified and validated; all you have to do now is rake in the profits right? Think again, the process of maintaining the validated...

Understanding Statistical Intervals: Part 2 - Prediction Intervals

Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...

Understanding Statistical Intervals Part 1 - Confidence Intervals

Statistical intervals are staples of the quality and validation practitioner’s statistical tool box. Statistical intervals can manifest as plus-or-minus limits on test data, represent a margin of...

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