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Posted Date: 11 Jun 2010 Posted By:: Krunal Member Level: Silver Points: 5 (₹ 1)
2010 Ganpat University Pharmacy M.Pharm Pharmaceutics Process Validation & cGMP Question paper
M Pharm Sem-II
June 2010 Examination
Subject: Process validation & cGMP
Date: 7/6/2010 Time : 3 hours Maximum marks: 70
1) Answer & tie both sections separately.
2) Figure to the right indicates marks
Q-1 Answer any five. 05
a) Enlist any different parameters for method validation
b) Define LOD & LOQ.
c) Define Robustness & ruggedness.
d) Differentiate patent & exclusivity.
e) Explain how bias affects accuracy & precision.
f) Define quality audit
g) Give classification of NDA.
Q-2 Answer any one. 10
a) Write a detailed note on process validation of tablet manufacturing process.
b) What is hypothesis? Explain it. Write a role of statistics on hypothesis.
Q-3 Write any four. 20
a) Enumerate ten principles of GMP.
b) What are drug development & approval process steps?
c) Differentiate between QA & QC emphasizing on consistency.
d) Give regulatory requirement of packaging & labelling of pharmaceuticals.
Q-4 Answer any five. 05
a) Differentiate selectivity & specificity.
b) Define process validation.
c) Define accuracy & precision.
d) Define ISO. Enlist classification of it.
e) Define 502 (b2) filing. Enlist its commercial advantage.
f) Define systemic, cluster & stratified sampling.
g) Define DMF.
Q-5 Answer any one. 10
a) Enlist various regulatory authorities of different countries in the world. Explain any two of them in detail.
b) What is NDA? Explain classification system in NDA.
Q-6 Write any four. 20
a) Discuss IPQC for LVP products.
b) Explain degree of freedom & type-I & type-II error.
c) Explain level of significance & c0nfidence intervals.
d) Define role of data exclusivity in intellectual property.
e) What is importance of cGMP in pharmaceuticals?
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