SOP Preparation / SOP revision in pharmaceutical industry l Standard operating procedure l Interview Question and answers
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Questions covered:
Q. What is SOP in the pharmaceutical industry ?
Q. Which documents shall be preferred for preparing new SOP ?
Q. What are the important components of SOP in the pharmaceutical industry ?
Q. What are the different types of SOP’s in the pharmaceutical industry ?
Q. For equipment's / instruments at which stage of qualification SOP shall be prepared?
Q. When SOP shall be revised in the pharmaceutical industry ?
Q. Who shall prepare and approve SOP ?
Q. What triggers SOP revision in the pharmaceutical industry ?
Q. Why training is important on SOP once it is newly prepared or revised ?
Q. Can you describe the process of SOP revision and approval ?
Q. How do you ensure that SOPs are easily understandable for all employees ?
Q. How do you involve cross-functional teams in the SOP development process ?
Q. Why it is necessary to circulate prepared draft SOP to the responsible persons before finalizing?
Q. What key factors should be considered when drafting a new Standard Operating Procedure (SOP) to ensure compliance with regulatory requirements (e.g., FDA, EMA, WHO)?
Q. What is basic requirement for SOP numbering ?
Q. Why initiating change control for preparation or revision of SOP is necessary ?
Q. What software's or applications nowadays commonly used in the pharmaceutical industry for SOP revision, SOP review or approval ?
Q. Which guidelines are commonly referred for SOP preparation or revision in the pharmaceutical industry ?
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Keywords to find this video:
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