FACULTY OF PHARMACY
M. Pharmacy (Pharmaceutics) I-Semester (Supple.) Examination, August 2018
Subject: Regulatory Affairs
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1 Explain the importance of documentation in pharmaceutical industry and add a note
on master formula record, distribution records.
Write a note on Code Of Federal Regulation.
2 Explain ANDA regulatory approval process.
3 What are the regulatory requirements for approval of an API?
4 Write a note on
CTD and eCTD
ICH Quality guidelines
5 Explain the regulatory requirements of EU
6 Discuss about regulations for Combination products and Medical devices.
7 Write a note on
informed consent process and procedures
Pharmacovigilance safety monitoring
8 Write a note on
Investigator brochure
investigation of medicinal products dossier