FACULTY OF PHARMACY
M. Pharmacy (Pharm.Analysis) II-Semester (Main) Examination, August 2018
Subject: Quality Controls and Quality Assurance
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Describe concept, components of Quality Assurance and Quality control.
2 What are the requirements of an organization and personnel as per USFDA?
3 Describe the in process quality control and finished products quality control
of tablet according to Indian pharmacopeia.
4 Write a brief notes on Quality audit plan
Batch formula record
5 Write the detail notes on the following
Expiry date calculation
Limitations of production
Calculation of yields
6 Describe the overview of ICH Guidelines with Q series
Write notes on SOP.
7 Write note on the aseptic process control.
Write about the organization and personnel responsibilities as per WHO.
8. Describe the onsite sanitation of manufacturing premises
Write note on finished product