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

Download PTU (I.K. Gujral Punjab Technical University Jalandhar (IKGPTU) M.Pharma 2020 March (Master of Pharmacy) 1st Sem 74701 Quality Control & Quality Assurance Previous Question Paper

1 | M-74701 (S31)-1129

Roll No. Total No. of Pages : 01
Total No. of Questions : 06
M.Pharmacy (Pharmaceutical Quality Assurance) (2017 & Onwards)
(Sem.?1)
QUALITY CONTROL & QUALITY ASSURANCE
Subject Code : MQA-103T
M.Code : 74701
Time : 3 Hrs. Max. Marks: 75
INSTRUCTIONS TO CANDIDATES :
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.
a. GLP 5
b. State of art animal house 5
c. Q series guidelines 5
2. Write short notes on :
a. IPQC 5
b. QC of tablets as per US Pharmacopeia 5
c. ICH Q 6 guidelines 5
3. Discuss the process and preparation for inspection of pharmaceutical industry as per
USFDA in detail. 15
4. Briefly discuss the following :
a. CTD & eCTD format 7
b. Three tier documentation 8
5. Write short notes on :
a. Cross contamination 5
b. CDER & CBER 5
c. Schedule M 5
6. a. Write note on importance of IPR. 9
b. Elaborate on impact of time limitation on production of drugs. 6
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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