JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

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. M.Pharm I Year I Sem (Pharmaceutical Regulatory Affairs)