Firstranker's choice
NRJ/KW/17/4290
--- Content provided by FirstRanker.com ---
B.Pharm. Semester—VI (C.B.S.) Examination
PHARMACEUTICAL VALIDATION
Paper-6
Time: Three Hours]
--- Content provided by FirstRanker.com ---
[Maximum Marks: 80
N.B. :— (1) Question No. 1 is compulsory.
(2) Solve any four questions from remaining.
(3) Draw neat labeled diagram wherever necessary.
(4) Assume suitable data wherever necessary.
--- Content provided by FirstRanker.com ---
(5) Discuss the reaction, mechanism wherever necessary.
(6) Use of electronic calculator is permitted.
1. Solve any five of the following :
(a) Give the composition of validation committee.
(b) Write in short about repeatability parameter in analytical method validation.
--- Content provided by FirstRanker.com ---
(c) Give the different conditions which require revalidation study in pharmaceutical processes.
(d) Write the significance of raw material validation in solid dosage forms.
(e) Give the different key physicochemical properties of the drug substance that need to be considered in developing tablet formulation.
(f) What is retrospective validation ? Discuss in short about criteria for product to be considered for retrospective validation.
(g) Write the rationale of prospective process validation. 5×4=20
--- Content provided by FirstRanker.com ---
2. Describe in brief about the following :
(a) Validation protocol and report.
(b) Preapproval inspection in pharmaceutical industry.
(c) Product design and development stage of pharmaceutical process validation. 15
3. Discuss in detail process development program in prospective process validation. 15
--- Content provided by FirstRanker.com ---
4. Describe selection and evaluation of processing data of solution dosage form with reference to retrospective validation. 15
POY-25696
(Contd.)
Discuss in detail the following unit operations with reference to process evaluation and selection in process validation of tablet dosage forms
--- Content provided by FirstRanker.com ---
(a) Mixing
(b) Drying
(c) Milling. 15
6. (a) Enlist the different parameters for analytical method validation. Discuss in detail about linearity parameter for analytical method validation. 7
(b) Discuss in detail selection and evaluation of processing data of soft gelatin capsules in reference to retrospective validation. 8
--- Content provided by FirstRanker.com ---
7. Write short notes (Any three) :
(a) Finished product tests for validation of solid dosage forms.
(b) Selection and evaluation of packaging data in reference to retrospective validation.
(c) Factors to consider during encapsulation step in process validation of capsule dosage form.
(d) Limit of detection and robustness in analytical method validation. 3×5=15
--- Content provided by FirstRanker.com ---
POY-25696
NRJ/KW/17/4290
--- Content provided by 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