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Total No. of Pages : 01
Total No. of Questions : 06
M.Pharmacy (Pharmaceutical Quality Assurance) (2017 & Onwards)
(Sem.-2)
PHARMACEUTICAL VALIDATION
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Subject Code : MQA-202T
M.Code: 76351
Time: 3 Hrs.
Max. Marks: 75
INSTRUCTIONS TO CANDIDATES :
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- Attempt any FIVE questions out of SIX questions.
- Each question carry FIFTEEN marks.
- A) What is meant by IQ, OQ and PQ? Outline the general procedures for them.
B) What is meant by calibration? Briefly explain the process of calibrating a weighing balance. - A) Explain the procedure for validating dry powder mixers.
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B) Outline the essential steps involved in calibrating FTIR. - A) Mention the principle of operation of 'friability test apparatus'. Explain the process of validating its operation.
B) Write a note on need and steps involved in validation of water systems in a pharmaceutical industry. - A) Explain repeatability and robustness with examples.
- A) Write a note on cleaning-in-place.
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B) Describe the validation of manufacturing process for coated tablet giving a fish-bone diagram. - A) What are trademarks? Describe the importance of trademarks and penalties for its infringement.
B) Describe the process of filing an International Patent.
NOTE : Disclosure of Identity by writing Mobile No. or Making of passing request on any page of Answer Sheet will lead to UMC against the Student.
1| M-76351
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(S31)-2707
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