What are the filing requirements for ANDA-USA, Europe, Brazil, South Africa, Japan and Emerging Markets

0 Answers  

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what is the diffirence between deviation and change control? at what situations we can raise the deviation and change control

31 Answers   Biocon, Cipla, DRL, Glenmark, Granules, Lupin, Micro Labs, Mylan, Natco, Ranbaxy, Swissmedic,

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why nitrogen charecter as a inert gas plz identified

0 Answers   Saurav Chemicals,

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Assume that you've been hired for the position. A mother calls and says her child is sick and she needs an appointment this morning. You don't have an open appointment for the morning. What will you do?

1 Answers  

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Which types of deviations are followed in pharmaceuial API manufacturing industry?

1 Answers   Laurus,

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What are the foods gets Vitamin B19?

1 Answers  

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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.

0 Answers   Alchem, Getz Pharma Research, Hovid Berhad,

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what is the leak test procedure of filled bottles (liquid)

0 Answers   Celon Labs, Cipla,

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difference between related substances and purity?

1 Answers   Micro Labs, Zydus Cadila,

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What is the differance Between Calibration & Validation

6 Answers   Gland Chemicals, MSN Pharma,

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How do you fix the known and unknown impurity limit for a drug substance?

2 Answers   IBM,

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What is forced degradation study?

0 Answers  

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