Download PTU (Punjab Technical University) M-Pharma (Master of Pharmacy) 2nd Semester 76351 PHARMACEUTICAL VALIDATION Last 10 Years 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011 and 2010 Previous Question Papers.
Roll No. Total No. of Pages : 01
Total No. of Questions : 06
M.Pharmacy (Pharmaceutical Quality Assurance) (2017 & Onwards)
(Sem.?2)
PHARMACEUTICAL VALIDATION
Subject Code : MQA-202T
M.Code : 76351
Time : 3 Hrs. Max. Marks: 75
INSTRUCTIONS TO CANDIDATES :
1. Attempt any FIVE questions out of SIX questions.
2. Each question carry FIFTEEN marks.
1. A) What is meant by IQ, OQ and PQ? Outline the general procedures for them.
B) What is meant by calibration? Briefly explain the process of calibrating a weighing
balance.
2. A) Explain the procedure for validating dry powder mixers.
B) Outline the essential steps involved in calibrating FTIR.
3. A) Mention the principle of operation of 'friability test apparatus'. Explain the process of
validating its operation.
B) Write a note on need and steps involved in validation of water systems in a
pharmaceutical industry.
4. A) Explain repeatability and robustness with examples.
B) Describe the validation of manufacturing process for coated tablet giving a fish-bone
diagram.
5. A) Write a note on cleaning-in-place.
B) Discuss the requirements for electronic records according to USFDA guidelines.
6. A) What are trademarks? Describe the importance of trademarks and penalties for its
infringement.
B) Describe the process of filing an International Patent.
NOTE : Disclosure of Identity by writing Mobile No. or Making of passing request on any
page of Answer Sheet will lead to UMC against the Student.
FirstRanker.com - FirstRanker's Choice
This post was last modified on 07 December 2019