Exam Details
| Subject | pharmaceutical production management & technology | |
| Paper | ||
| Exam / Course | m.pharm | |
| Department | ||
| Organization | Gujarat Technological University | |
| Position | ||
| Exam Date | May, 2018 | |
| City, State | gujarat, ahmedabad |
Question Paper
Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Ph. SEMESTER- II EXAMINATION SUMMER -2018
Subject Code: MPT201T Date: 14/05/2018
Subject Name: Pharmaceutical Production Management Technology
Time: 10:30AM TO 01:30PM 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 the facilities required in an area for sterile product .manufacturing.
06
Discuss the FFS technology for manufacturing of parenterals.
05
Discuss in brief about Needle free Injections.
05
Q.2
What is waste management? Discuss its importance in in Pharmaceutical industry.
06
Describe techniques of waste water treatment.
05
How is fire hazard prevented and monitored in a Pharmaceutical industry?
05
Q.3
Write a note on Unit dose packaging.
06
Describe Strip packaging materials in brief.
05
Discuss evaluation of packaging materials.
05
Q.4
What is pilot Plant Scaleup? Discuss general considerations for pilot plant scaleup.
06
Discuss various technical aspects to be addressed during scale up.
05
With a suitable diagram describe the pilot plant layout design
05
Q.5
Describe tablet manufacturing process by wet granulation with a suitable flow diagram. Discuss the in process quality tests required during manufacturing of tablets.
06
Discuss in brief rapid mixing granulators in tablet manufacturing.
05
Describe equipments for tablet coating. Discuss fluidized bed coater in brief.
05
Q. 6
Describe production management and production organization in brief.
06
Discuss quality estimation of a process using control charts and using Cp CpK
05
Discuss Scale up of liquid dosage forms
05
Q.7
Describe in process quality control tests for hard and soft capsules
Explain the principle and process of lyophilization technology.
06
Write a note on HVAC system in a Pharmaceutical industry.
05
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Ph. SEMESTER- II EXAMINATION SUMMER -2018
Subject Code: MPT201T Date: 14/05/2018
Subject Name: Pharmaceutical Production Management Technology
Time: 10:30AM TO 01:30PM 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 the facilities required in an area for sterile product .manufacturing.
06
Discuss the FFS technology for manufacturing of parenterals.
05
Discuss in brief about Needle free Injections.
05
Q.2
What is waste management? Discuss its importance in in Pharmaceutical industry.
06
Describe techniques of waste water treatment.
05
How is fire hazard prevented and monitored in a Pharmaceutical industry?
05
Q.3
Write a note on Unit dose packaging.
06
Describe Strip packaging materials in brief.
05
Discuss evaluation of packaging materials.
05
Q.4
What is pilot Plant Scaleup? Discuss general considerations for pilot plant scaleup.
06
Discuss various technical aspects to be addressed during scale up.
05
With a suitable diagram describe the pilot plant layout design
05
Q.5
Describe tablet manufacturing process by wet granulation with a suitable flow diagram. Discuss the in process quality tests required during manufacturing of tablets.
06
Discuss in brief rapid mixing granulators in tablet manufacturing.
05
Describe equipments for tablet coating. Discuss fluidized bed coater in brief.
05
Q. 6
Describe production management and production organization in brief.
06
Discuss quality estimation of a process using control charts and using Cp CpK
05
Discuss Scale up of liquid dosage forms
05
Q.7
Describe in process quality control tests for hard and soft capsules
Explain the principle and process of lyophilization technology.
06
Write a note on HVAC system in a Pharmaceutical industry.
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