Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MRA102T Date: 03/01/2019
Subject Name: Documentation and Regulatory Writing
Time 10:30 AM TO 01:30 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

How we will plan product development and guideline for product development report?
06

What do you mean by internal audit? Give brief guideline for internal audit.
05

What is EPDB for Drug substance?
05
Q.2

Describe overview and modules of CTD.
06

What is MFR. How to prepare MFR?
05

Brief out preparation, plan, strategies and follow up of audit.
05
Q.3

Write process of submission in Sugam System of CDSCO.
06

What do you mean by batch reconciliation and how you maintain batch packaging records?
05

Brief description of e-CTD process.
05
Q.4

Briefly describe the content and guidline of DMF.
06

How will you prepare audit compliance report?
05

Describe in brief CoA.
05
Q.5

Give brief out of Site master file.
06

What do you mean by GHTF study group for guidance document?
05

What do you mean by third party audit?
05
Q. 6

Quality system required for GMP certification.
06

Brief describe CAPA.
05

How will you find out root cause analysis of deviation?
05
Q.7

What do you mean by SUPAC. Explain guideline in brief.
06

Guideline for preparation of Annual Report.
05

Short description: ISO Risk Management Standard.
05