Download RTMNU B.Pharma 6th Semester 2016 Winter Pharmaceutical Validation Question Paper

Download RTMNU (Rashtrasant Tukadoji Maharaj Nagpur University) B.Pharma (Bachelor of Pharmacy) 6th Semester 2016 Winter Pharmaceutical Validation Question Paper

KNT/KW/16/6575
B.Pharm Semester?VI (C.B.S) Examination
PHARMACEUTICAL VALIDATION
Paper?6 (6T6)
Time : Three Hours] [Full Marks : 80
NB. :? (1) Question N0. 1 is compulsory.
(2) Solve any F OUR questions from the remaining.
(3) Draw neat labeled diagram wherever necessary.
1. Solve any ?ve of the following :
(a) Define process validation. Comment on its various options.
(b) Draw ?ow diagram showing different steps involved in selection of candidates for retrospective
validation.
(c) Discuss the various parameters to be considered during development and validation of wet granulation
technique.
((1) Explain cause and effect diagram.
(e) Discuss the various factors to consider during encapsulation step in process validation of hard gelatin
capsules.
(1) Give the different critical process steps and quality control test in process validation of compressed
tablets.
(g) Draw typical process ?ow diagram for granulated product. 5X4=20
2. Brie?y describe the various stages of validation. 15
3. Explain in detail about the following parameters for analytical method validation :
(a) Selectivity and speci?city. 5
(b) Precision and reproducibility. 5
(c) Accuracy and recovery. 5
NVM?6947 (Contd)

4. (a) Brie?y comment on validation of raw materials for solid dosage forms. 8
(b) Write in brief about various in-process tests required for solid dosage forms in process validation.
7
5. Explain selection and evaluation of processing data of coated tablets with reference to retrospective
validation. 15
6. Write brie?y about :
(a) Experimental design and analysis. 7
(b) Full-scale product/process development in prospective process validation. 8
7. Write short notes on (any three) :
(a) Pilot plant scale-up and technology transfer.
(b) Physicochemical properties of the drug in developing tablet formulation.
(c) Selection and evaluation of processing data of semisolid dosage forms in retrospective validation.
(d) Linearity and calibration curve. 3 X5:15
NVM?6947 KNT/KW/ 16/6575