Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MQA203T Date: 19/11/2018
Subject Name: Audits and Regulatory Compliance
Time :02:30 PM TO 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

Explain objectives and management of an audit.
06

Write short note on audit deficiencies.
05

Discuss planning process of an audit.
05
Q.2

Write about responsibilities, information gathering and administration of an audit.
06

Explain cGMP regulations in brief.
05

Discuss in detail about audit checklist for drug industries.
05
Q.3

Discuss quality assurance functions and quality system approaches in pharmaceutical industries.
06

Short note on auditing of vendors.
05

Explain regulatory requirements of bulk pharmaceuticals.
05
Q.4

Explain auditing of weighing and warehouse stocks.
06

Write note on auditing of manufacturing process.
05

Explain regulatory requirements of tableting and coating.
05
Q.5

Discuss regulatory requirements for sterile production and packaging.
06

Explain auditing of HVAC system.
05

Describe auditing of WFI.
05
Q. 6

Write the process and steps for an audit of microbiological laboratory.
06

Discuss auditing of quality assurance department.
05

Define: Audit, Regulatory compliance, QA, ETP and QMS.
05
Q.7

Explain the audit role played by QA in quality control function.
06

Write short note on QMS.
05

Explain regulatory compliance of chemicals and packaging material.
05