Ganpat University 2010 M.Pharm Pharmaceutics Process Validation

Ganpat university
M Pharm Sem-II
June 2010 exam
Subject: Process validation & cGMP
Date: 7/6/2010 Time : three hours Maximum marks: 70


Instructions:
1) Answer & tie both parts separately.
2) Figure to the right shows marks

part -I

Q-1 Answer any five. 05

a) Enlist any various 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? discuss 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 ranging from QA & QC emphasizing on consistency.
d) Give regulatory requirement of packaging & labelling of pharmaceuticals.

part –II

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 different regulatory authorities of various countries in the world. discuss any 2 of them in detail.
b) What is NDA? discuss 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 fault.
c) Explain level of significance & c0nfidence intervals.
d) Define role of data exclusivity in intellectual property.
e) What is importance of cGMP in pharmaceuticals?

Earning:   Approval pending.