Download RTMNU B.Pharma 6th Semester 2016 Summer Pharmaceutical Validation Question Paper

Download RTMNU (Rashtrasant Tukadoji Maharaj Nagpur University) B.Pharma (Bachelor of Pharmacy) 6th Semester 2016 Summer Pharmaceutical Validation Question Paper

TKN/KS/16?7004
Sixth Semester Examination for the Degree
01? Bachelor of Pharmacy
PHARMACEUTICAL VALIDATION
6 T 6
Time : Three Hours ] [ Max. Marks : 80
N. B. : (1) Question No. l is compulsory.
(2) Attempt any four questions from the remaining.
(3) Draw neat labelled diagram wherever necessary.
1. Answer any ?ve questins ?om following
(21) Write brief account on ? process validation options.
(b) Explain in brief ? The validation committee.
(0) Enlist components of validation Master plan.
(d) Write brief account on validation protocol.
(6) Write short note on preapproved inspection.
(1) Explain in brief ? Technical transfer.
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(g) Write short note on Pilot Plant Scale up.
Answer any four questions from following.
2. Discuss in detail :?
(a) Different stages of validation.
(b) Change control validation process. 15
3. Discuss prospective process validation. 15
TKN/KS/16 ? 7004 Contd.
4. Explain parameters for analytical method validation. 15
5. Write detailed account of product selection criteria for
retrospective validation. 15
6. Explain validation of raw materials for solid dosage form.
15
7. Write brief account on :?
(a) Selection and evaluation of processing data soft
gelatin capsules.
(b) Finished product tests for solid dosage form. 15
TKN/KS/16?7004 2 850