Download PTU M.Pharm 2020 March 1st Sem 74701 Quality Control & Quality Assurance Question Paper

Roll No. _________________________ Total No. of Pages : 01

Total No. of Questions : 06

M.Pharmacy (Pharmaceutical Quality Assurance) (2017 & Onwards) (Sem.-1)

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QUALITY CONTROL & QUALITY ASSURANCE

Subject Code : MQA-103T

M.Code : 74701 Max. Marks: 75

Time : 3 Hrs.

INSTRUCTIONS TO CANDIDATES :

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1. Attempt any FIVE questions out of SIX questions.
2. Each question carries FIFTEEN marks.

1. Give detailed account on the following with suitable examples.
   1. GLP 5
   2. State of art animal house 5
   3. Q series guidelines 5

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2. Write short notes on :
   1. IPQC 5
   2. QC of tablets as per US Pharmacopeia 5
   3. ICH Q 6 guidelines 5

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3. Discuss the process and preparation for inspection of pharmaceutical industry as per USFDA in detail. 15
4. Briefly discuss the following:
   1. CTD & eCTD format 7
   2. Three tier documentation 8
5. Write short notes on :
   1. Cross contamination 5

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   2. CDER & CBER 5
   3. Schedule M 5
6. 1. Write note on importance of IPR. 9
   2. Elaborate on impact of time limitation on production of drugs. 6

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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.

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