MAY 2017 Sub. Code: 2916
M.PHARM. DEGREE EXAMINATION
FIRST YEAR
BRANCH V PHARMACEUTICAL ANALYSIS
PAPER IV QUALITY CONTROL AND QUALITY ASSURANCE
Q.P. Code 262916
Time Three hours Maximum 100 Marks
I. Elaborate on: x 20 40)
1. Explain in detail the regulatory affairs of UKMCA.
Give a detailed account on location and building requirements for pharma
industry.
2. Discuss the different types of closures and closure liners. Explain quality control
of packaging material and filling equipment.
II. Write notes on: (10 x 6 60)
1. What is quality audit? Explain the quality auditing of laboratories.
2. Controls on animal house.
3. Sterlisation of area.
4. When pharmaceutical products are recalled from market?
5. Good Laboratory Practice (GLP).
6. Write the note on certification.
7. Write the concept of loan license auditing.
8. Write the significance of environmental protection act.
9. Import policy.
10. Therapeutic Goods Administration (TGA).