Gujarat Technological University 2012-2nd Sem M.Pharm - – –, Industrial Pharmacy - IV - Question Paper
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Univesity Name: Gujrat Technological University
Paper name:Industrial Pharmacy - IV
Academic Year: 2012
Courses: M.Pharm 2nd semester exam
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Seat No.:__Enrolment No._
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM- SEM-II-EXAMINATION - JULY 2012 Subject code: 2920208 Date: 09/07/2012
Subject Name: Industrial Pharmacy - IV
Time: 10:30 am - 01:30 pm Total Marks: 80
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
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Q.1 |
(a) |
What do you understand by Quality Assurance? Write about quality audits in detail. |
08 |
|
(b) |
Write about ISO 9000 series. |
08 | |
|
Q.2 |
(a) |
What do you mean by Precision, Accuracy and Bias? Write a note on statistical hypothesis testing. |
08 |
|
(b) |
Write a detailed note on New Drug Application approval process. |
08 | |
|
Q.3 |
(a) |
Write a note on general requirements of USFDA. |
08 |
|
(b) |
Write about regulatory aspects of pharmaceutical excipients. |
08 | |
|
Q.4 |
(a) |
Write about the role of Medicinal Control Council (MCC) in regulating the health of public. |
08 |
|
(b) |
Write a detailed note on various methods of sampling. |
08 | |
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Q.5 |
(a) |
Write about regulatory issues in Indian Pharmaceutical Industry. |
08 |
|
(b) |
How a monograph for a bulk drug substance in developed in Indian Pharmacopoeia (IP)? |
08 | |
|
Q. 6 |
(a) |
Write about the followings: 1) Process validation 2) Retrospective validation 3) Revalidation 4) Concurrent validation |
08 |
|
(b) |
How a tablet coater is evaluated for coating process? |
04 | |
|
(c) |
Write a note on Electronic Records (21CFR11). |
04 |
Q. 7 Write short notes on followings: 16
1) Drug Master File(DMF)
2) CDER
3) OHSAS
4) ICH guidelines
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Attachment: |
| Earning: Approval pending. |
