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Total No. of Pages : 02
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Roll No.
Total No. of Questions : 22
B.Pharm (2017 Batch) (Sem.-6)
QUALITY ASSURANCE-THEORY
Subject Code : BP-606T
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M.Code: 77991
Time: 3 Hrs.
Max. Marks : 75
INSTRUCTIONS TO CANDIDATES :
- SECTION-A is COMPULSORY consisting of TEN questions carrying TWO marks each.
- SECTION-B contains THREE questions carrying TEN marks each and students have to attempt any TWO questions.
- SECTION-C contains NINE questions carrying FIVE marks each and students have to attempt any SEVEN questions.
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SECTION-A
Define briefly :
- Difference between QA and QC
- Master Formula Record
- Quality audit
- Validation
- SOP
- Material Management
- Control Articles
- Difference between primary and secondary packaging material
- Line clearance
- Pareto analysis
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SECTION-B
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- ICH guidelines are divided into which major categories, enumerate them with codes and explain guidelines for stability testing.
- Define QBD. What are different components of QBD? Discuss in brief.
- Discuss the general principle of calibration. Also brief about Analytical method Validation.
SECTION-C
- Define TQM. Enumerate components of TQM. Explain in detail any one of them.
- Enumerate different quality management tools and explain fish bone diagram.
- Explain Matrix design.
- Briefly discuss ISO 14000
- What are the principals of NABL Accreditation?
- Discuss the significance of personnel responsibilities.
- What is the procedure of purchase of equipments?
- What is the protocol for conduct of A Non clinical Laboratory Study?
- What is significance of SOP? Discuss the significance of reports and documents.
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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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This download link is referred from the post: PTU B.Pharma 6th Semester Last 10 Years 2011-2021 Previous Question Papers|| Punjab Technical University