Exam Details
| Subject | quality management system | |
| Paper | ||
| Exam / Course | m.pharm. pharmaceutics | |
| Department | ||
| Organization | solapur university | |
| Position | ||
| Exam Date | May, 2018 | |
| City, State | maharashtra, solapur |
Question Paper
Master of Pharmacy (Semester (New CBCS) Examination, 2018
Pharmaceutical Quality Assurance
Quality Management System
Day and Date Saturday, 5-5-2018 Total Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
What are the quality systems standards
Explain in brief ISO 9001:2008.
Explain in brief out of specification and out of trend (OOT).
Give detail focus on principles of six sigma.
Write an account on McKinsey 7S model.
Write a note on strategic planning and implementation for quality.
II. Answer any three questions (3×10=30)
Give detail account on total quality management.
Explain in detail customer perception of quality and factors affecting customer perception.
Give a detail note on categories and models of cost quality.
Explain in detail statistical process control charts and control chart analysis.
III. Give detail focus on WHO-GMP requirement for pharmaceutical
quality management. 20
Pharmaceutical Quality Assurance
Quality Management System
Day and Date Saturday, 5-5-2018 Total Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
What are the quality systems standards
Explain in brief ISO 9001:2008.
Explain in brief out of specification and out of trend (OOT).
Give detail focus on principles of six sigma.
Write an account on McKinsey 7S model.
Write a note on strategic planning and implementation for quality.
II. Answer any three questions (3×10=30)
Give detail account on total quality management.
Explain in detail customer perception of quality and factors affecting customer perception.
Give a detail note on categories and models of cost quality.
Explain in detail statistical process control charts and control chart analysis.
III. Give detail focus on WHO-GMP requirement for pharmaceutical
quality management. 20
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)