Download RTMNU B.Pharma 6th Semester 2017 Summer Pharmaceutical Validation Question Paper

B.Pharm (Sixth Semester) (C.B.S.) Examination

PHARMACEUTICAL VALIDATION

Paper-6

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Time : Three Hours] [Maximum Marks : 80

N.B. :— (1) Question No. 1 is compulsory.

(2) Solve any four questions from the remaining.

(3) Draw neat labeled diagram wherever necessary.

1. Solve any five of the following :

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   1. What are various process validation options ? 4
   2. Explain product development in prospective process validation. 4
   3. Explain the various parameters to be considered during development and validation of dry granulation technique. 4
   4. How do you select the product for retrospective validation ? 4
   5. What are the different parameters for analytical method validation ? 4

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   6. What are the different guidelines for process validation of solid dosage form ? 4
   7. Write in short about validation committee. 4
2. 1. Discuss in detail about pre approval inspection and pilot plant scale up. 8
   2. Write in detail about validation protocol and report. 7

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3. 1. Explain in detail about product development of prospective process validation. 10
   2. Write about organisation of prospective process validation. 5
4. 1. Explain in detail about accuracy and recovery in analytical method validation. 8

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   2. What do you mean by precision, linearity and robustness in analytical method validation ? 7
5. 1. Discuss in detail selection and evaluation of processing data of compressed tablets with relation to retrospective validation. 10
   2. Write about computer aided analysis of data. 5

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6. What are the different in-process tests and finished product test of solid dosage form ? 15

7. Write notes on any (two) : 15

   1. Selection and evaluation of processing data of solutions.
   2. Master documentation.
   3. Process validation of hard gelatin capsules.

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