twenty five. Could you discuss a time when you productively scaled up a chemical procedure from lab scale to generation scale?
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Qualification will be the motion of proving and documenting that any gear or ancillary devices are properly mounted, function appropriately, actually demonstrate the anticipated final results. Qualification is a component of validation, but the person qualification measures by itself usually do not represent method validation.
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A documented description from the operation to be performed, the safeguards to become taken, and actions to be applied specifically or indirectly related to the manufacture of the intermediate / API (Reference: ICH Q7A).
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“In a single instance, I used to be Portion of a group working on an oral medication with reduced bioavailability because get more info of its bad solubility. We decided to explore using nanotechnology for drug supply.
b. When intermediates and merchandise cannot be remarkably characterized and very well-described quality characteristics can't be identified.
They are the pretty to start with rollers in rotary tablet press. Mainly, these rollers implement a small amount of drive over the higher and reduced punches.
Who of you groaned or grew to become upset any time you observed math in your routine? Who of you've got delay math until eventually you Definitely needed to consider it?
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Swab sampling: Spots which might be fairly obtainable & toughest to clean is often evaluated, resulting in level of contamination or residue for every provides area spot.
This question is a immediate probe into your difficulty-fixing expertise and resilience, that are both of those necessary qualities for A prosperous pharmaceutical chemist. Exploration perform often consists of unforeseen twists and turns.