Download GTU B.Pharma 2020 Winter 7th Sem BP706TT Quality Assurance Question Paper

Download GTU (Gujarat Technological University Ahmedabad) B.Pharma (Bachelor of Pharmacy) 2020 Winter 7th Sem BP706TT Quality Assurance Previous Question Paper

Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B. Pharm ? SEMESTER VII? EXAMINATION ? WINTER -2020
Subject Code: BP706TT
Date: 12/01/2021
Subject Name: Quality Assurance
Time: 10:30AM To 12:30PM
Total Marks: 54
Instructions:


1. Attempt any THREE questions from Q-1 to Q-6.
2. Q.7 is compulsory to attempt.
3. Make suitable assumptions wherever necessary.
4. Figures to the right indicate full marks.

Q.1 (a) Write is the difference between QA and QC. How QA, QC and GMP are 06
correlated?

(b) Enlist different ICH guidelines. Discuss in brief about Quality guideline.
05

(c) What is QbD? Discuss different tools of QbD.
05



Q.2 (a) Draw a sample plant layout for pharmaceutical industry along with space 06
required as per schedule M.

(b) Discuss maintenance of sterile area and control of contamination as a part of 05
plant premises.

(c) Discuss various quality control tests for secondary packaging materials.
05



Q.3 (a) Give brief note on ISO 9000 & ISO 14000? Discuss various steps for its 06
registration.

(b) Discuss principles of GLP.
05

(c) What is TQM? Explained various elements of TQM.
05



Q.4 (a) Give brief note on Quality control test for containers and rubber closures.
06

(b) What is difference between calibration, validation and qualification? Discuss any 05
two validation parameters in detail.

(c) Discuss various characteristics to be validated for different types of analytical 05
procedures.



Q.5 (a) What is a complaint? Discuss how to handle returns goods.
06

(b) Discuss BMR and its auditing with references to cGMP.
05

(c) Write a note on Master Formula Record.
05



Q. 6 (a) Define calibration. Discuss principles of calibration.
06

(b) Discuss general protocol for conduct of a Nonclinical laboratory study.
05

(c) Write brief note on SOP.
05



Q.7 (a) Discuss about personnel responsibility and hygiene in pharmaceutical industry.
06
OR

(a) What is NABL accreditation? Discuss its importance.
06
OR

(a) Write short note on Qualification of UV-Visible spectrophotometer.
06
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