OCTOBER 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. How the quality control of packing material is achieved?
What are the tests to be performed for assuring quality of glass?
Write a detailed note on concepts and philosophy of Total Quality
Management.
2. What is inprocess quality control? Add a note on its importance. Discuss briefly
the various inprocess quality control tests carried out for the following dosage
forms.
Liquid orals Tablets Capsules.
II. Write notes on: (10 x 6 60)
1. Briefly write the quality review.
2. Write the importance of patenting drug products and process.
3. Sop for coating.
4. Consumer protection act.
5. Role of master formula in record maintenance.
6. Give an account on product recall with reference related records and documents.
7. What are the responsibilities of a Quality Control Laboratory?
8. List out the various responsibilities of qualified personnel in a manufacturing unit.
9. WHO certification.
10. Discuss the salient features of environmental protection act.