Rajiv Gandhi University of Health Sciences
First Year M Pharm Degree Examination
Chemical and Biological Evaluation (Revised Scheme 4)
[Time: 3 Hours] [Max. Marks: 100]
Q.P. CODE: 9360
Your answers should be specific to the questions asked.
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Draw neat, labeled diagrams wherever necessary. Answer any ten questions.
LONG ESSAY (Answer any TEN) 10 X 10 = 100 Marks
- Discuss warehouse and vendor audit. Explain briefly the handling of returned pharmaceutical products.
- Explain WHO certification for export of pharmaceuticals.
- Write about tests for effectiveness of antimicrobial preservatives.
- Explain the applications and validation of computers in quality control laboratory.
- Explain the procedure for the calibration of HPLC and FT-IR.
- Discuss cleaning and personnel validation in pharmaceutical industry.
- Write the properties and tests for Bacterial pyrogen and Endotoxins.
- Explain chemical and biological analysis of water for injection.
- Explain the concept, methodology involved in microbiological assay of antibiotics.
- Explain biological sample preparation for Liquid-liquid extraction and solid phase micro extraction.
- How is cleaning limits for cleaning validation set?
- Explain the limits for residual solvents for drug substances as per ICH guidelines.
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