Answer Posted / suvra jyoti dutta

Dossier is a file document submitted for the approval of
drug product.It is submitted in form of CTD to the
regulatory agency. CTD is a harmonized format (template)
for presenting data in the ICH regions.

Can any one tell me that which brand hplc column is used for levetiracetam imp- b test.

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Tell us about your oncology experience.

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please explain the job responsibilities of quality assurance..

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what is your experience in medical continuing education.

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What is difference between Warm and Lukewarm Water as per pharmacopia.

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Tell us about a time when you failed to meet a deadline. What were the repercussions?

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Anyone have any idea when to conduct Uniformity of Weight (UOW) and when need to conduct Uniformity of Dosage Units (UOD) or when need both? I read BP it only said if average weight < or = 0.04g then just conduct UOD, no need UOW. Under UOD section, it doesnt say when need to conduct UOD but just said UOD got two type, one is Mass Variation (MV), another is Content Uniformity (CU) and under what conditions to conduct them. For USP, no UOW section, only got UOD section.

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what is meant by artwork review and handling procedure with an example?

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difference between RF and correction factor?

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If calibration of 12 bowl dissolution apparatus does not meets single stage procedure, how can u proceed calibration?

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What is the basic requirement for preparing drug master file , like EDMF , USDMF ?

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How can I assign a retest date for solvents e.g. toluene, methanol, etc?

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What are the regulatory commitments in markets like USA, Canada, Europe, Brazil, South Africa and Japan

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How to do IR test of hydroscopic materials

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You will be required to interact with patients. Tell us about your previous experience with patients and how did you deal with the experience.

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