B. Pharmacy 6th Semester-2021
Time: Three hours
M. Marks: 75
Note: 1. It is compulsory to attempt all questions of Section-A.
2. Attempt any two questions from Section-B,
Attempt any seven questions from Section-C.
Important: 4. Use only blue/black ink pen to attempt answers, Use of pencil is prohibited.
Q.1 Answer all the questions:
(a) What is meant by precision?
(b) What is meant by retrospective validation?
(c) What is a 'draft guideline'?
(d) Define TQM.
(e) What are ICH Q10 guidelines?
() What are ICHE 2E guidelines?
(g) Mention the purpose of vendor qualification.
(h) Mention the guidelines for genotoxicity testing of pharmaceuticals.
(1) What is CTD and what is its purpose?
) What is LOD?
Long answer type questions. Answer any two questions out of the 10x2=20
following three questions.
Q,2 Give a detailed account of QbD for formulations explaining various techniques
used along with their limitations.
Q.3 Discuss the Iso 9000 provisions in detail with respect to pharmaceutical
Q.4 Discuss the steps involved in analytical validation and explain the different terms
used in this process.
Short answer type questions. Answer any seven questions out of the
following nine guestions.
Q.5 Explain the prospective validation process and its applications.
Q.6 Give a brief account of requirement for premises of a liquid oral formulation plant.
Q.7 Mention the types of consumer complaints and the process of handling thềm.
Q.8 What is meant by pull and push method for material issue? Give suitable
Q.9 What is the difference between LOC and range during analytical validation?
Q.10 Give an overview of the methods used for documentation in pharmaceutical
Q.11 Briefly explain the steps involved in material storage in pharmaceutical plants.
Q.12 Mention the different types of validations and highlight the situations when they
Q.13 Give an overview of the components of GLP.