Exam Details
| Subject | gmp, glp and validation | |
| Paper | ||
| Exam / Course | m.pharm | |
| Department | ||
| Organization | Gujarat Technological University | |
| Position | ||
| Exam Date | May, 2017 | |
| City, State | gujarat, ahmedabad |
Question Paper
Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm. SEMESTER II • EXAMINATION SUMMER 2017
Subject code: 1921502 Date: 31/05/2017
Subject Name: GMP, GLP AND VALIDATION
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
Write a note on analytical method validation parameters as per ICH
06
Write a note on vendor selection and certification.
05
Write note on complaint product recall.
05
Q.2
Define validation. Write advantages disadvantages, limitation of validation and explain various type of validation.
08
Write a note on following (any two)
Validation of HPLC ii) Validation of Dissolution test apparatus
iii) Validation of U.V./Visible spectrophotometer
08
Q.3
Describe the GMP guidelines for personnel selection, training and responsibilities.
06
Write a note on in process control in manufacturing design and development of ophthalmic preparation.
05
Explain roles and responsibilities of QA and QC in pharmaceutical industries.
05
Q.4
What is IPQC? Explain in brief the IPQC parameters observed during the production of tablets.
08
What are SOPs? Give objectives of SOP. Enumerate the topics of SOP. Describe the general format for SOP in detail.
08
Q.5
Write an account of Good Distribution Practices.
08
Write a detail note on GLP
08
Q. 6
Write a note on cleaning validation.
06
Write a note on computer system validation.
05
Write note on validation master plan(VMP)
05
Q. 7
Write an account of Good Warehouse Practices.
08
Describe details of in-process quality checks performed for sterile dosage forms.
08
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Pharm. SEMESTER II • EXAMINATION SUMMER 2017
Subject code: 1921502 Date: 31/05/2017
Subject Name: GMP, GLP AND VALIDATION
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
Write a note on analytical method validation parameters as per ICH
06
Write a note on vendor selection and certification.
05
Write note on complaint product recall.
05
Q.2
Define validation. Write advantages disadvantages, limitation of validation and explain various type of validation.
08
Write a note on following (any two)
Validation of HPLC ii) Validation of Dissolution test apparatus
iii) Validation of U.V./Visible spectrophotometer
08
Q.3
Describe the GMP guidelines for personnel selection, training and responsibilities.
06
Write a note on in process control in manufacturing design and development of ophthalmic preparation.
05
Explain roles and responsibilities of QA and QC in pharmaceutical industries.
05
Q.4
What is IPQC? Explain in brief the IPQC parameters observed during the production of tablets.
08
What are SOPs? Give objectives of SOP. Enumerate the topics of SOP. Describe the general format for SOP in detail.
08
Q.5
Write an account of Good Distribution Practices.
08
Write a detail note on GLP
08
Q. 6
Write a note on cleaning validation.
06
Write a note on computer system validation.
05
Write note on validation master plan(VMP)
05
Q. 7
Write an account of Good Warehouse Practices.
08
Describe details of in-process quality checks performed for sterile dosage forms.
08
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