Regulatory practices and documentation lab Detailed Syllabus for Pharmaceutical Regulatory Affairs M.Pharm first year first sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.
The detailed syllabus for Regulatory practices and documentation lab M.Pharm 2017-2018 (R17) first year first sem is as follows.
M.Pharm. I Year I Sem
List of experiments:
- Case studies (4 Nos.) of each of Good Pharmaceutical Practices.
- Documentation for in process and finished products Quality control tests for Solid, liquid, Semisolid and Sterile preparations.
- Preparation of SOPs, Analytical reports (Stability and validation)
- Protocol preparation for documentation of various types of records (BMR,MFR, DR) Labeling comparison between brand & generics.
- Preparation of regulatory dossier as per Indian CTD format and submission in SUGAM
- Case studies on response with scientific rationale to USFDA Warning Letter
- Preparation of submission checklist of IMPD for EU submission.
- Comparison study of marketing authorization procedures in EU.
For all other M.Pharm 1st Year 1st Sem syllabus go to JNTUH M.Pharm Pharmaceutical Regulatory Affairs 1st Year 1st Sem Course Structure for (R17) Batch.
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