Download RTMNU (Rashtrasant Tukadoji Maharaj Nagpur University) B.Pharma (Bachelor of Pharmacy) 6th Semester 2017 Summer Pharmaceutical Validation Question Paper
B.Pharm (Sixth Semester) (C.B.S.) Examination
PHARMACEUTICAL VALIDATION
Paper?6
Time : Three Hours] [Maximum Marks : 80
NB. :? (1) Question No. 1 is compulsory.
(2) Solve any four questions from the remaining.
(3) Draw neat labeled diagram wherever necessary.
1. Solve any ?ve of the following :
(a) What are various process validation options ? 4
(b) Explain product development in prospective process validation. 4
(0) Explain the various parameters to be considered during development and validation of dry
granulation technique. 4
(d) How do you select the product for retrospective validation ? 4
(e) What are the different parameters for analytical method validation ? 4
(1) What are the different guidelines for process validation of solid dosage form ? 4
(g) Write in short about validation committee. 4
2. (a) Discuss in detail about pre approval inspection and pilot plant scale up. 8
(b) Write in detail about validation protocol and report. 7
3. (a) Explain in detail about product development of prospective process validation. 10
(b) Write about organisation of prospective process validation. 5
4. (a) Explain in detail about accuracy and recovery in analytical method validation. 8
(b) What do you mean by precision, linearity and robustness in analytical method validation ? 7
5. (a) Discuss in detail selection and evaluation of processing data of compressed tablets with relation
to retrospective validation. 10
(b) Write about computer aided analysis of data. 5
What are the different in?process tests and ?nished product test of solid dosage form ? 15
Write notes on any (two) : 15
(a) Selection and evaluation of processing data of solutions.
(b) Master documentation.
(0) Process validation of hard gelatin capsules.
NXO?203 1 8
This post was last modified on 19 January 2020