Exam Details
| Subject | quality assurance techniques – iii | |
| Paper | ||
| Exam / Course | m.pharm. pharmaceutics | |
| Department | ||
| Organization | solapur university | |
| Position | ||
| Exam Date | May, 2017 | |
| City, State | maharashtra, solapur |
Question Paper
M. Pharmacy (Semester II) Examination, 2017
QUALITY ASSURANCE
Quality Assurance Techniques III (CGPA/CBCS)
Day and Date Monday, 8-5-2017 Total Marks 70
Time 10.30 a.m. to 1.30 p.m.
A. Answer any three. (3×10=30)
Discuss the verification of qualification of dissolution apparatus.
What is validation of Analytical method Name typical analytical
characteristics used in method validation.
Define Active Ingredient, In-process Material, Biostatics and goal of CPCSEA.
What is biostatics Explain the graphical presentation of data with example.
What is the regression analysis
B. Answer all. (2×20=40)
What are cGMPs Define drug product, strength and batch. Give guidelines
for sampling and testing of in-process material and drug products in establishing
appropriate process control. Discuss process validation.
What is OECD What are its 3R-principles Discuss the content of protocol
for and conduct of non clinical laboratory study (FDA/GLP).
QUALITY ASSURANCE
Quality Assurance Techniques III (CGPA/CBCS)
Day and Date Monday, 8-5-2017 Total Marks 70
Time 10.30 a.m. to 1.30 p.m.
A. Answer any three. (3×10=30)
Discuss the verification of qualification of dissolution apparatus.
What is validation of Analytical method Name typical analytical
characteristics used in method validation.
Define Active Ingredient, In-process Material, Biostatics and goal of CPCSEA.
What is biostatics Explain the graphical presentation of data with example.
What is the regression analysis
B. Answer all. (2×20=40)
What are cGMPs Define drug product, strength and batch. Give guidelines
for sampling and testing of in-process material and drug products in establishing
appropriate process control. Discuss process validation.
What is OECD What are its 3R-principles Discuss the content of protocol
for and conduct of non clinical laboratory study (FDA/GLP).
Subjects
- advanced biopharmaceutics and pharmacokinetics
- advanced pharmaceutical analysis (old)
- advanced pharmaceutical chemistry – i (old)
- advanced pharmaceutical chemistry – ii
- advanced pharmaceutical chemistry – iii (old) (cgpa/cbcs)
- advanced pharmaceutics – ii
- advanced pharmaceutics – iii (old)
- advances in drug delivery (old)
- audits and regulatory compliance
- computer aided drug delivery system
- cosmeticology (elective)
- cosmetics and cosmeceutica
- cosmetics and cosmeceuticals
- drug delivery system
- drug design (elective) (old)
- elective : quality control (old)
- hazards and safety management
- modern pharmaceutical analytical technique
- modern pharmaceutical analytical techniques
- modern pharmaceutics
- molecular pharmaceutics (nano tech and targeted dds)
- pharmaceutical manufacturing technology
- pharmaceutical validation
- pharmaceutics (biopharmaceutics and pharmacokinetics(old) (elective)
- product development (elective)(old)
- product development and technology transfer
- quality assurance
- quality assurance techniques – i
- quality assurance techniques – ii (old)
- quality assurance techniques – iii
- quality control (old)
- quality control and quality assurance
- quality management system
- regulatory affairs
- sterile product formulation and technology
- sterile product formulation and technology (old) (elective)
- therapeutic drug monitoring (old) (elective)