Exam Details
| Subject | pharmaceutical validation | |
| Paper | ||
| Exam / Course | m.pharm. pharmaceutics | |
| Department | ||
| Organization | solapur university | |
| Position | ||
| Exam Date | May, 2018 | |
| City, State | maharashtra, solapur |
Question Paper
Master of Pharmacy (Semester II) (New CBCS) Examination, 2018
Pharmaceutical Quality Assurance
Pharmaceutical Validation
Day and Date Monday, 7-5-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Explain the stages of validation of equipment.
Write a note on validation documentation.
Explain the method of calibration of volumetric flask and burette.
Elaborate on usefulness of operational qualification of equipments.
Explain the critical attributes of water system to be met during its validation.
Write a note on TRIPS Agreement and its impact on Indian Pharma Industry.
II. Answer any three questions (3×10=30)
Describe the method of validation of UV-Visible spectrophotometer.
Explain the important considerations in validation of cleaning.
Describe the steps involved in the development of analytical method.
Explain the media fill validation method for aseptic filling.
III. Explain in detail types of process validation. Add a note on change control. 20
Pharmaceutical Quality Assurance
Pharmaceutical Validation
Day and Date Monday, 7-5-2018 Max. Marks 75
Time 10.30 a.m. to 1.30 p.m.
I. Answer any five questions
Explain the stages of validation of equipment.
Write a note on validation documentation.
Explain the method of calibration of volumetric flask and burette.
Elaborate on usefulness of operational qualification of equipments.
Explain the critical attributes of water system to be met during its validation.
Write a note on TRIPS Agreement and its impact on Indian Pharma Industry.
II. Answer any three questions (3×10=30)
Describe the method of validation of UV-Visible spectrophotometer.
Explain the important considerations in validation of cleaning.
Describe the steps involved in the development of analytical method.
Explain the media fill validation method for aseptic filling.
III. Explain in detail types of process validation. Add a note on change control. 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)