This download link is referred from the post: RTMNU B-Pharm Last 10 Years 2010-2020 Previous Question Papers || Rashtrasant Tukadoji Maharaj Nagpur University
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B.Pharm Semester–VI (C.B.S) Examination
PHARMACEUTICAL VALIDATION
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Paper-6 (6T6)
[Full Marks: 80 Time : Three Hours]
N.B. :- (1) Question No. 1 is compulsory.
(2) Solve any FOUR questions from the remaining.
(3) Draw neat labeled diagram wherever necessary.
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- Solve any five of the following : (5×4=20)
- Define process validation. Comment on its various options.
- Draw flow diagram showing different steps involved in selection of candidates for retrospective validation.
- Discuss the various parameters to be considered during development and validation of wet granulation technique.
- Explain cause and effect diagram.
- Discuss the various factors to consider during encapsulation step in process validation of hard gelatin capsules.
- Give the different critical process steps and quality control test in process validation of compressed tablets.
- Draw typical process flow diagram for granulated product.
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- Briefly describe the various stages of validation. (15)
- Explain in detail about the following parameters for analytical method validation :
- Selectivity and specificity. (5)
- Precision and reproducibility. (5)
- Accuracy and recovery. (5)
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- Briefly comment on validation of raw materials for solid dosage forms. (8)
- Write in brief about various in-process tests required for solid dosage forms in process validation. (7)
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- Explain selection and evaluation of processing data of coated tablets with reference to retrospective validation. (15)
- Write briefly about :
- Experimental design and analysis. (7)
- Full-scale product/process development in prospective process validation. (8)
- Write short notes on (any three) : (3×5=15)
- Pilot plant scale-up and technology transfer.
- Physicochemical properties of the drug in developing tablet formulation.
- Selection and evaluation of processing data of semisolid dosage forms in retrospective validation.
- Linearity and calibration curve.
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Visit FirstRanker.com
This download link is referred from the post: RTMNU B-Pharm Last 10 Years 2010-2020 Previous Question Papers || Rashtrasant Tukadoji Maharaj Nagpur University
--- Content provided by FirstRanker.com ---