Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2018 May (Master of Pharmacy) 2nd Year 5151 Quality Control And Quality Assurance II Previous Question Paper

Rajiv Gandhi University of Health Sciences
Second Semester M. Pharm Degree Examination - MAY-2018
[Time: 3 Hours]
[Max. Marks: 75]
Quality Control and Quality Assurance -II
Q.P. CODE: 5151
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three)
3 X 10 = 30 Marks
1.
Explain in detail Good Laboratory Practices.
2.
Describe the c-GMP guidelines according to schedule M with respect to organization
personnel responsibilities training and hygiene.
3.
Explain the quality control tests for parenteral products.
4.
Elaborate on NABL certification and accreditation procedure.
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
Write in brief patent regime and IPR.
6.
Explain the brief maintenance of sterile areas in drug industry.
7.
Write the quality control test for suppositories.
8.
Write a note on batch formula record.
9.
How to write a SOP?
10.
Write a brief note on release of finished products.
11.
Explain the qualities control test for containers in Pharmaceutical Industry.
12.
Write about Quality Assurance unit.
13.
Explain the sanitation procedures in drug industry.
14.
Explain CPCSEA guidelines in general.
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