Gujarat Technological University 2010 M.Pharm Global Regulatory Requirements - Question Paper

GUJARAT TECHNOLOGICAL UNIVERSITY

M. Pharmacy Sem-II Examination July 2010

Seat No.    Enrolment No.

Subject code: 920202 Subject Name: Global Regulatory Requirements

07 /07 /2010    Time: 11.00 am - 02.00 pm

Instructions:    Total Marks: 80

1.    Attempt any five questions.

2.    Make suitable assumptions wherever necessary.

3.    Figures to the right indicate full marks.

Q.1 (a) Define Pharmaceutical Packaging. What are the conditions pertaining to 06 containers as per USP? Discuss the objectives, importance and functions of packaging.

(b)    What are the innovations in tamperproof packaging and coding systems? 05 What are package integrity tests for Parenterals?

(c)    Comment on suitability of APIs with packaging material.    05 Write a note on packages for pediatrics and geriatrics.

Q.2 (a) What is cleaning validation? What are current regulatory requirements for 06 it? What ICH talks about Analytical methods development and validation?

(b)    Why the computer system needs to be validated? How entrepreneur    05 resource planning make use of computers?

(c)    Write a note on qualifications of Pharma. Process equipment and write a 05 note on validation of an autoclave.

Q.3 (a) What is the need for Orange book? Suggest equivalence related terms and 06 statistical criteria for bio-equivalence. How to use cumulative supplement?

(b)    Discuss the historical aspects of drug development and approval. Which 05 information can be obtained as per FOIA?

approval of NDAs/ ANDAs?

(b)    Write a note on ANDA. Discuss Drug Price Competition and Patent    05 restoration act of 1984 and WAXMAN-HATCH ACT are the same and its economics on the society is important.

Q.5 (a) What USFDA does and does not regulate? How will you prepare for    06