Dr. A.P.J. Abdul Kalam University M.Pharm (Quality Assurance) II SEM Audits and Regulatory Compliance [MQA203T] June 2021 Question Paper

Dr. A.P.J. Abdul Kalam University

Master of Pharmacy (Quality Assurance)

Second Semester Examination, June-2021

Audits and Regulatory Compliance [MQA203T]

Time: 3:00 Hrs Max Marks 75

Note: (i) Attempt any five questions.

 (ii) All questions carry equal marks.

Q.1 (a) What is the the importance of auditing in pharmaceutical

industries.

(b) Write the brief note on auditing report.

Q.2 (a) Write prepareation of check list for auditing.

(b) Give Objectives of Management of audit, Responsibilities,

Planning process,

Q.3 (a) Write information gathering, administration, Classifications of

deficiencies.

(b) Which Role play quality systems and audits in pharmaceutical

manufacturing environment.

Q.4 Write short on following:-

(a) Explain Quality systems approach Management

(b) Explain about Manufacturing operations, Evaluation activities quality

system.

Q.5 (a) What do you mean by Transitioning to quality system approach.

(b) Give the Audit checklist for drug industries.

Q.6 (a) Explain about Auditing of vendors and production department.

(b) Bulk Pharmaceutical Chemicals and packaging material Vendor audit.

Q.7 (a) Auditing in Warehouse and weighing, Dry Production:

(b) Granulation, tableting, coating, capsules, sterile production and

packaging.

Q.8 (a) Give brief introduction on HVAC system ,

(b) Explain Water for Injection systems, ETP.

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