Exam Details
| Subject | quality management system | |
| Paper | ||
| Exam / Course | m.pharm. pharmaceutics | |
| Department | ||
| Organization | solapur university | |
| Position | ||
| Exam Date | December, 2018 | |
| City, State | maharashtra, solapur |
Question Paper
Master of Pharmacy (Semester (New CBCS) Examination, 2018
pharmaceutical quality assurance
Quality Management System
Day and Date Monday, 10-12-2018 Total Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Write a note on strategic planning and implementation for quality.
Give an account on ICH guidelines for stability testing of drug substances.
Explain in brief estimation of inherent capability from a control chart analysis.
Write an account on McKinsey 7S model.
Explain in detail factors affecting customer perception.
What are the quality systems standards
II. Answer any three questions (3×10=30)
Write a note on evolution and dimensions of quality.
Explain in detail about six system inspection model.
Explain in detail about the customer focus in pharmaceutical quality
management system.
Explain in details about the cost of quality and categories of cost of quality.
III. Give detail focus on WHO-GMP requirement for pharmaceutical quality
management.
pharmaceutical quality assurance
Quality Management System
Day and Date Monday, 10-12-2018 Total Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Write a note on strategic planning and implementation for quality.
Give an account on ICH guidelines for stability testing of drug substances.
Explain in brief estimation of inherent capability from a control chart analysis.
Write an account on McKinsey 7S model.
Explain in detail factors affecting customer perception.
What are the quality systems standards
II. Answer any three questions (3×10=30)
Write a note on evolution and dimensions of quality.
Explain in detail about six system inspection model.
Explain in detail about the customer focus in pharmaceutical quality
management system.
Explain in details about the cost of quality and categories of cost of quality.
III. Give detail focus on WHO-GMP requirement for pharmaceutical quality
management.
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)