Exam Details
| Subject | pharmaceutical validation | |
| 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 II) (New CBCS) Examination, 2018
pharmaceutical quality assurance
pharmaceutical validation
Day and Date Tuesday, 11-12-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Describe the major phases of pharmaceutical validation.
What are the benefits of cleaning validation
Explain the critical attributes of facility to be met during its validation.
Elaborate on usefulness of performance qualification of equipments.
Write a note on validation of HVAC.
Explain the salient features of trademarks.
II. Answer any three questions (3×10=30)
Describe the methodology of qualification of pharmaceutical equipments.
Explain the method of validation of autoclave.
Describe the procedure for process validation of granulation by giving a suitable
example.
Write a note on Validation Protocols and Reports.
III. Giving suitable examples explain the types of process validation. 20
pharmaceutical quality assurance
pharmaceutical validation
Day and Date Tuesday, 11-12-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Describe the major phases of pharmaceutical validation.
What are the benefits of cleaning validation
Explain the critical attributes of facility to be met during its validation.
Elaborate on usefulness of performance qualification of equipments.
Write a note on validation of HVAC.
Explain the salient features of trademarks.
II. Answer any three questions (3×10=30)
Describe the methodology of qualification of pharmaceutical equipments.
Explain the method of validation of autoclave.
Describe the procedure for process validation of granulation by giving a suitable
example.
Write a note on Validation Protocols and Reports.
III. Giving suitable examples explain the types of process validation. 20
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)