Download PTU B.Pharma 2020 Dec 6th Sem 77991 Quality Assurance Theory Question Paper

Download PTU I. K. Gujral Punjab Technical University (IKGPTU) B.Pharma (Bachelor of Pharmacy) 2020 December 6th Sem 77991 Quality Assurance Theory Previous Question Paper

Roll No.
Total No. of Pages : 02
Total No. of Questions : 22
B.Pharm (2017 Batch) (Sem.-6)
QUALITY ASSURANCE-THEORY
Subject Code : BP-606T
M.Code : 77991
Time : 3 Hrs. Max. Marks : 75
INST RUCT IONS T O CANDIDAT ES :
1 .
SECT ION-A is COMPULSORY cons is ting of TEN questions carrying TWO marks
each.
2 .
SECT ION-B contains THREE questions carrying T EN marks e ach and s tudents
have to atte mpt any T WO questio ns.
3 .
SECT ION-C c ontains NINE questions ca rrying F IVE marks eac h and s tud ents
have to atte mpt any SEVEN que stions .
SECTION-A
Define briefly :
1. Difference between QA and QC
2. Master Formula Record
3. Quality audit
4. Validation
5. SOP
6. Material Management
7. Control Articles
8. Difference between primary and secondary packaging material
9. Line clearance
10. Pareto analysis
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SECTION-B
11.
ICH guidelines are divided into which major categories, enumerate them with codes
and explain guidelines for stability testing.
12.
Define QBD. What are different components of QBD? Discuss in brief.
13.
Discuss the general principle of calibration. Also brief about Analytical method
Validation.
SECTION-C
14.
Define TQM. Enumerate components of TQM. Explain in detail any one of them.
15.
Enumerate different quality management tools and explain fish bone diagram.
16.
Explain Matrix design.
17.
Briefly discuss ISO 14000
18.
What are the principals of NABL Accreditation?
19.
Discuss the significance of personnel responsibilities.
20.
What is the procedure of purchase of equipments?
21.
What is the protocol for conduct of A Non clinical Laboratory Study?
22.
What is significance of SOP? Discuss the significance of reports and documents.
NOTE : Disclosure of identity by writing mobile number or making passing request on any
page of Answer sheet will lead to UMC against the Student.
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