Exam Details
Subject | quality control (old) | |
Paper | ||
Exam / Course | m.pharm. pharmaceutics | |
Department | ||
Organization | solapur university | |
Position | ||
Exam Date | May, 2018 | |
City, State | maharashtra, solapur |
Question Paper
M. Pharmacy (Sem. II) (CGPA/CBCS) Examination, 2018
Pharmaceutical Quality Assurance
quality control
Day and Date Friday, 11-5-2018 Total Marks 70
Time 10.30 a.m. to 1.30 p.m.
A. Answer any three (3×10=30)
Define pharmaceutical standard and reference standard How are these fixed Add a note on contents of an ideal monograph as per current USP.
What is bioavailability and bioequivalence Explain the need of bioequivalence studies.
Write a brief note on principles of quality risk management.
What do you understand by the term Quality by design Explain the steps involved therein.
B. Answer all (2×20=40)
What is shelf life Explain in brief real time and accelerated stability testing.
Write a brief note on
In-process quality control
Phases of clinical trials.
Pharmaceutical Quality Assurance
quality control
Day and Date Friday, 11-5-2018 Total Marks 70
Time 10.30 a.m. to 1.30 p.m.
A. Answer any three (3×10=30)
Define pharmaceutical standard and reference standard How are these fixed Add a note on contents of an ideal monograph as per current USP.
What is bioavailability and bioequivalence Explain the need of bioequivalence studies.
Write a brief note on principles of quality risk management.
What do you understand by the term Quality by design Explain the steps involved therein.
B. Answer all (2×20=40)
What is shelf life Explain in brief real time and accelerated stability testing.
Write a brief note on
In-process quality control
Phases of clinical trials.
Other Question Papers
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)