Enrolment No
B.PHARM - SEMESTER- 7 EXAMINATION - WINTER -2019
Subject Code: 2270014 Date: 28-11-2019
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Subject Name: Instrumental and process validation
Time: 10:30AM TO 01:30PM Total Marks: 80
Instructions:
- Attempt any five questions.
- Make suitable assumptions wherever necessary.
- Figures to the right indicate full marks.
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Q.1 (a) Explain the strategy of Industrial Process Validation of Solid Dosage Form. 06
(b) Discuss the steps involved in qualification of autoclave. 05
(c) Write in short about validation master plan. 05
Q.2 (a) Describe validation of HPLC system. 06
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(b) What do you understand by Theoretical Plate concept and how HETP affects the separation of HPLC column? 05
(c) What is operational qualification and performance qualification of equipment. 05
Q.3 (a) What are the objectives and stages of cleaning validation. 06
(b) How will you optimize mobile phase in HPLC method development. 05
(c) Discuss the principles and application of flow injection analysis. 05
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Q.4 (a) Draw schematic diagram of Gas chromatography. Give applications of GC. 06
(b) Define the following terms: i) Selectivity factor ii) Capacity factor iii) Plate height iv) Plate number v) Column resolution 05
(c) Discuss the various types of automated instruments. 05
Q.5 (a) Discuss the detectors used in gas chromatography. 06
(b) Discuss the scope and advantages of pharmaceutical process validation. 05
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(c) What do you understand by flow injection analysis. 05
Q.6 (a) How will you validate sterile products. Discuss in brief. 06
(b) Discuss the types of process validation. 05
(c) Write a note on HPLC instrumentation. 05
Q.7 (a) Discuss the steps involved in selection of detector in HPLC method development. 06
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(b) How will you validate bioanalytical HPLC method. 03
(c) Discuss cleaning validation. 05
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