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Roll No.
Total No. of Questions : 06
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Total No. of Pages : 01
M.Pharmacy (Pharmaceutical Quality Assurance) (2017 & Onwards)
(Sem.-2)
AUDITS & REGULATORY COMPLIANCE
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Subject Code : MQA-203T
M.Code: 76352
Time: 3 Hrs.
Max. Marks: 75
INSTRUCTIONS TO CANDIDATES :
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- Attempt any FIVE questions out of SIX questions.
- Each question carry FIFTEEN marks.
- 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. - A) Write a note on quality systems approach.
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B) Give an overview of the cGMP requirements with respect to auditing of pharmaceutical manufacturing units. - A) Describe the key features involved during auditing of a sterile powder manufacturing section.
B) Outline the process adopted for auditing packaging material vendors. - 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. - Highlight the importance of HVAC auditing in a sterile manufacturing plant. Give a detailed account of auditing these systems.
- What is effluent treatment plant and what is its purpose? Give a detailed account of its auditing process.
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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.
1| M-76352
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(S31)-2729
This download link is referred from the post: University of Jaffna Sri Lanka B.Pharma Last 10 Years 2010-2020 Previous Question Papers || University of Sri Lanka
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