25. Are you able to talk about a time once you efficiently scaled up a chemical procedure from lab scale to creation scale?
The immersion tube technique which includes a tube which will immerse in the tablet bed and this tube provides a spray nozzle that provides equally the new air and coating Option. This can be appropriate for both of those sugar coating and film coating.
Additionally, it involves the main points from the activity done by whom, checked by whom, at what time action was executed, at what day exercise was executed and signature of the personnel involved in the batch or activity.
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This question is asked to gauge your complex expertise and dilemma-resolving competencies. For a pharmaceutical chemist, you’re predicted to continuously Enhance the drug delivery units to enhance effectiveness and effectiveness.
As a pharmaceutical chemist, your function has the opportunity to immediately impact human wellness and wellness. Thus, adhering to FDA rules is not only a legal requirement but a ethical obligation.
This question is important mainly because it invites you to demonstrate your know-how and experience inside the really crucial levels of drug development. Preclinical and medical trials would be the backbone of pharmaceutical exploration, read more where security and efficacy of latest medicine are analyzed.
“In a single occasion, I was Element of a crew working on an oral medication with small bioavailability due to its weak solubility. We made a decision to discover using nanotechnology for drug delivery.
A Management approach is often a prepared set of controls, derived from recent merchandise and approach being familiar with that assures system overall performance and item high quality (ICH Q10).
“I’ve been associated with both preclinical and scientific trials through my career. From the preclinical period, I used to be Element of click here a group that built and executed research to evaluate the safety and efficacy of recent drug compounds in vitro and in animal models.
“Optimization of drug shipping and delivery programs consists of a multi-faceted solution. I typically use in silico modeling to predict the behavior of various formulations and evaluate their prospective efficacy.
The QTPP is defined by capturing all relevant high quality specifications with the drug merchandise to get formulated.
This indicates the repeating of the part of or a whole PPQ study while in the event of improvements in the process, products, etc. or like a advice from the CPV course of action to validate no matter whether a procedure continues in the validated state of Regulate and/or to verify which the changes never adversely impact procedure qualities and product top quality or even the validated condition of Charge of the procedure
My proficiency extends to troubleshooting prevalent troubles including baseline drifts or peak tailing in HPLC, and signal sound in NMR spectra. I am also comfortable with details interpretation from the two devices.