Exam Details
| Subject | quality management system | |
| Paper | ||
| Exam / Course | m.pharm | |
| Department | ||
| Organization | Gujarat Technological University | |
| Position | ||
| Exam Date | January, 2019 | |
| City, State | gujarat, ahmedabad |
Question Paper
Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MQA102T Date: 03/01/2019
Subject Name: Quality Management System
Time :10:30 AM TO 01:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q-1
Explain Evolution of Quality and Dimensions of Quality. Discuss strategic quality management.
Write a note on McKinsey 7s model
Classify customer. Explain Customer focus, Customer perception of quality and Factors affecting customer perception
Q-2
What is Cost of quality? Discuss Categories of cost of Quality and Models of cost of quality.
Explain NABL certification and accreditation.
Write a note on Handling customer complaints.
Q-3
Write a note on Basics of Quality Management and Total Quality Management
Give short note on Six sigma
Give short note on ICH Q10
Q-4
Enlist WHO-GMP requirements and explain in 2-3 lines about each
Give note on CFR-21 part 11
What is Change Management? Explain Change control.
Q-5
Discuss and differentiate Out of Specifications and Out of Trend
Discuss Corrective Preventive Actions (CAPA)
What is importance of Vendor Qualification? Explain
Q-6
Enlist ICH guidelines for Quality Section.
Discuss ICH requirements for evaluation of Drug Stability.
Write a note on Quality risk management
Q-7
Discuss Statistical Process control
Write a note on Statistical control charts
What is Quality Culture Benchmarking? Explain it
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MQA102T Date: 03/01/2019
Subject Name: Quality Management System
Time :10:30 AM TO 01:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q-1
Explain Evolution of Quality and Dimensions of Quality. Discuss strategic quality management.
Write a note on McKinsey 7s model
Classify customer. Explain Customer focus, Customer perception of quality and Factors affecting customer perception
Q-2
What is Cost of quality? Discuss Categories of cost of Quality and Models of cost of quality.
Explain NABL certification and accreditation.
Write a note on Handling customer complaints.
Q-3
Write a note on Basics of Quality Management and Total Quality Management
Give short note on Six sigma
Give short note on ICH Q10
Q-4
Enlist WHO-GMP requirements and explain in 2-3 lines about each
Give note on CFR-21 part 11
What is Change Management? Explain Change control.
Q-5
Discuss and differentiate Out of Specifications and Out of Trend
Discuss Corrective Preventive Actions (CAPA)
What is importance of Vendor Qualification? Explain
Q-6
Enlist ICH guidelines for Quality Section.
Discuss ICH requirements for evaluation of Drug Stability.
Write a note on Quality risk management
Q-7
Discuss Statistical Process control
Write a note on Statistical control charts
What is Quality Culture Benchmarking? Explain it
Other Question Papers
Subjects
- advanced medicinal chemistry
- advanced organic chemistry-i
- advanced organic chemistry-ii
- advanced pharmacology ii
- advanced pharmacology-i
- advances in drug delivery system
- advances in pharmacology
- applied pharmacotherapeutics - ii
- applied pharmacotherapeutics-i
- audits and regulatory compliance
- biological evaluations & clinical research
- cellular and molecular pharmacology
- clinical and hospital pharmacy
- clinical pharmacy practice
- clinical research and pharmacy practice
- clinical research and regulatory affairs
- clinical research regulations
- cosmetic and cosmeceuticals
- documentation and regulatory writing
- drug design and discovery
- drug regulation and regulatory authority
- experimental design and patents
- global regulatory requirements
- gmp, glp and validation
- good manufacturing and good laboratory practice
- good manufacturing practice and process validation
- good regulatory practices
- hazards and safety management
- industrial pharmacy practice
- modern analytical techniques
- modern pharmaceutical analysis
- novel drug delivery system part-i
- novel drug delivery system-ii
- pharm. management -ii
- pharmaceutical analysis ii
- pharmaceutical and cosmetic analysis
- pharmaceutical formulation and development
- pharmaceutical formulation development and biopharmceutics
- pharmaceutical manufacturing technology
- pharmaceutical production management & technology
- pharmaceutical regulatory affairs
- pharmacological and toxicological screening methods-i
- pharmacological and toxicological screening methods-ii
- pharmacometrics and methods of biological evaluation of drugs
- pharmacotherapeutics
- principles of biopharmaceutics& pharmacokinetics
- product development and technology transfer
- quality control & quality assurance
- quality control and quality assurance
- quality management system
- regulatory affairs - i
- regulatory affairs and new drug applications
- regulatory aspects of hebbal and biologicals
- research methodology
- validation and product development