Download PTU (Punjab Technical University) M-Pharma (Master of Pharmacy) 2nd Semester 76352 AUDITS and REGULATORY COMPLIANCE Last 10 Years 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011 and 2010 Previous Question Papers.
1 | M-76352 (S31)-2729
Roll No. Total No. of Pages : 01
Total No. of Questions : 06
M.Pharmacy (Pharmaceutical Quality Assurance) (2017 & Onwards)
(Sem.?2)
AUDITS & REGULATORY COMPLIANCE
Subject Code : MQA-203T
M.Code : 76352
Time : 3 Hrs. Max. Marks: 75
INSTRUCTIONS TO CANDIDATES :
1. Attempt any FIVE questions out of SIX questions.
2. Each question carry FIFTEEN marks.
l. A) Enumerate the objectives of an audit and responsibilities of an auditor. Enlist the
types of audit and their purpose.
B) Discuss the information gathered during audit process.
2. A) Write a note on quality systems approach.
B) Give an overview of the cGMP requirements with respect to auditing of
pharmaceutical manufacturing units.
3. A) Describe the key features involved during auditing of a sterile powder manufacturing
section.
B) Outline the process adopted for auditing packaging material vendors.
4. A) Discuss the importance of product information for microbiological processes with
regards to auditing.
B) Give an overview of auditing of manufacturing process involving microbiological
laboratory.
5. Highlight the importance of HVAC auditing in a sterile manufacturing plant. Give a
detailed account of auditing these systems.
6. What is effluent treatment plant and what is its purpose? Give a detailed account of its
auditing process.
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.
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This post was last modified on 07 December 2019