twenty five. Are you able to discuss a time any time you successfully scaled up a chemical procedure from lab scale to production scale?
In case of next two attainable scenarios, approach for being controlled applying operational limits and in-process monitoring:
Furthermore, it incorporates the small print from the activity executed by whom, checked by whom, at what time activity was carried out, at what day activity was executed and signature with the staff linked to the batch or activity.
Controlled / planned deviation: Any deviation from documented technique opted deliberately for temporary time period to manage unavoidable problem or improving upon the performance on the functions, without influencing the standard & generate of drug compound and safety with the operations shall be termed as controlled / prepared deviation.
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An action taken to remove the cause of the present deviation , incident or issue to be able to avoid its recurrence (taking place once again).
“In a single occasion, I used to be Section of a group focusing on an oral medication with reduced bioavailability on account of its bad solubility. We chose to explore using nanotechnology for drug supply.
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I redesigned the artificial route by changing some dangerous reagents with safer choices. I also optimized the reaction situations to boost yield and purity.
Depth the in-procedure Handle technique to be operated. This will range with regards to the complexity of the packaging functions.
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My proficiency extends to troubleshooting common issues including baseline drifts or peak tailing in HPLC, and signal sound in NMR spectra. I am also comfy with details interpretation from both of those instruments.