JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
REGULATORY PRACTICE AND DOCUMENTATION LAB
M.Pharmacy I Year I Semester (R19)
List of Experiments:
1. Case studies (4 Nos.) of each of Good Pharmaceutical Practices.
2. Documentation for in process and finished products Quality control tests for Solid, liquid, Semisolid and Sterile preparations.
3. Preparation of SOPs, Analytical reports (Stability and validation)
4. Protocol preparation for documentation of various types of records (BMR, MFR, DR) Labeling comparison between brand & generics.
5. Preparation of regulatory dossier as per Indian CTD format and submission in SUGAM
6. Case studies on response with scientific rationale to USFDA Warning Letter
7. Preparation of submission checklist of IMPD for EU submission.
8. Comparison study of marketing authorization procedures in EU. R19 M.PHARM PHARMACEUTICAL REGULATORY AFFAIRS M.Pharm I Year I Sem (Pharmaceutical Regulatory Affairs)