Exam Details
| Subject | quality control & quality assurance | |
| Paper | ||
| Exam / Course | m.pharm | |
| Department | ||
| Organization | Gujarat Technological University | |
| Position | ||
| Exam Date | May, 2017 | |
| City, State | gujarat, ahmedabad |
Question Paper
Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm SEMESTER-II • EXAMINATION SUMMER 2017
Subject Code: 2920207 Date: 31/05/2017
Subject Name: Quality Control Quality Assurance
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
Describe importance, principles and regulations of good distribution
Practices.
06
Write a detailed note on Risk management
05
Describe the key components of master formula record.
05
Q.2
What is quality audit? Give the objectives of qualily audit and benefits of GMP audit.
06
Write a note on master formula record OR batch formula record.
05
Give importance of waste and scrap disposal. Explain methods for biomedical waste.
05
Q.3
What are standard operating procedures? What are the factors must be considered while writing SOP.
06
Explain waste disposal procedures for pharmaceutical industry.
05
What are various ISO standards? Enlist them with their specific purpose.
05
Q.4
What are the personal qualifications required in an organization as per GMI? Give a neat and clean diagram of training and development cycle.
06
Discuss subpart D (equipment) as per cGMP.
05
Why it is important to do vendor qualification and certification?
05
Q.5
Describe the data to be submitted to the regulatory authority while applying the permission to conduct clinical trials in India.
06
Discuss the different tests used to check quality of glass used as a container in Pharmaceutical Product.
05
What is CTD? How it is useful in regulation of Pharmaceutical Products?
05
Q. 6
Explain in detail the regulatory procedure for the application of NDA.
06
Write a note on Air handling systems for sterile product as per GMP
05
Discuss in detail the procedure for obtaining patent in India
05
Q.7
What are the responsibilities of Production department of Pharm Industry?
06
Mention important verification steps for QA officer during packaging/labeling of finished product.
05
Discuss about stability testing of API as per ICH guideline.
05
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm SEMESTER-II • EXAMINATION SUMMER 2017
Subject Code: 2920207 Date: 31/05/2017
Subject Name: Quality Control Quality Assurance
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
Describe importance, principles and regulations of good distribution
Practices.
06
Write a detailed note on Risk management
05
Describe the key components of master formula record.
05
Q.2
What is quality audit? Give the objectives of qualily audit and benefits of GMP audit.
06
Write a note on master formula record OR batch formula record.
05
Give importance of waste and scrap disposal. Explain methods for biomedical waste.
05
Q.3
What are standard operating procedures? What are the factors must be considered while writing SOP.
06
Explain waste disposal procedures for pharmaceutical industry.
05
What are various ISO standards? Enlist them with their specific purpose.
05
Q.4
What are the personal qualifications required in an organization as per GMI? Give a neat and clean diagram of training and development cycle.
06
Discuss subpart D (equipment) as per cGMP.
05
Why it is important to do vendor qualification and certification?
05
Q.5
Describe the data to be submitted to the regulatory authority while applying the permission to conduct clinical trials in India.
06
Discuss the different tests used to check quality of glass used as a container in Pharmaceutical Product.
05
What is CTD? How it is useful in regulation of Pharmaceutical Products?
05
Q. 6
Explain in detail the regulatory procedure for the application of NDA.
06
Write a note on Air handling systems for sterile product as per GMP
05
Discuss in detail the procedure for obtaining patent in India
05
Q.7
What are the responsibilities of Production department of Pharm Industry?
06
Mention important verification steps for QA officer during packaging/labeling of finished product.
05
Discuss about stability testing of API as per ICH guideline.
05
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