Dr. A.P.J. Abdul Kalam University M PHARMACY I SEM (ALL BRANCH) Quality Control and Quality Assurance (MQA 103T) Dec 2020 Question Paper

Dr. A.P.J. Abdul Kalam University

Master of Pharmacy (Quality Assurance)

First Semester Main Examination, Dec-2020

Quality Control and Quality Assurance (MQA 103T)

Time: 3:00 Hrs Max Marks 75

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

Q.1 (a) Discuss IPQC and finished products QC for Surgical products as per IP.

(b) Enlist advantages and utility of batch manufacturing record.

Q.2 (a) High light the defects of cGMP guidelines.

(b) Enumerate PIC, WHO and CBER covering.

Q.3 (a) Elaborate GMP guidelines.

(b) Discuss concept of ICH guidelines

Q.4 (a) Discuss analysis of raw materials, finished products, packaging materials

in IPQC.

(b) Discuss developing specification as per ICH Q6 and Q3.

Q.5 (a) Discuss principle and steps involved in three tier documentation.

(b) Elaborate concepts of controlled and uncontrolled documents.

Q.6 (a) Discuss the steps and advantage of handling waste and scrop disposal.

(b) Define deviation. Discuss methodology of process deviation.

Q.7 (a) Define expiry date. Enlist expiry date calculation.

(b) Elaborate change control in Quality assurance.

Q.8 (a) Discuss scope and importance of intellectual property rights.

(b) Discuss concept of trade mark, copyright and patents. 

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