Dr. A.P.J. Abdul Kalam University M PHARMACY I SEM (ALL BRANCH) Quality Management System (MQA102T) Dec 2020 Question Paper

Dr. A.P.J. Abdul Kalam University

Master of Pharmacy (Quality Assurance)

First Semester Examination, Dec-2020

Quality Management System (MQA102T)

Time: 3:00 Hrs Max Marks 75

Note : Attempt any five questions. All questions carry equal marks.

Q.1 (a) Explain Quality & its objectives in detail.

(b) Explain McKinsey 7s Model in brief.

Q.2 (a) Write brief note on TQM.

(b) Explain Pharmaceutical Quality Management as per ICH Q-10

guidelines.

Q.3 (a) Explain Six System Inspection model in QMS.

(b) Write notes on Out of Specifications (OOS) & Out of trends (OOT).

Q.4 (a) Explain complaints of Pharmaceutical products. How the root cause can

be investigated & determine.

(b) Explain steps involve in returned and recalled products.

Q.5 (a) Define druge stability. Explain the ICH guidelines for stability testing of

drug substance & drug products.

(b) Explain quality risk management with reference to ICH-Q9 guidelines.

Q.6 (a) Write advantages, disadvantages & applications of statistical process

control.

(b) Explain statistical control chart in detail.

Q.7 (a) Explain types, advantages & disadvantages of Benchmarking.

(b) Write a note on HACCP.

Q.8 (a) Define Vendor. Explain vendor qualification in detail.

(b) Explain IPQC of Tablets.

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