Drug Regulatory Affairs Detailed Syllabus for Pharmaceutical Analysis & Quality Assurance / Quality Assurance 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 Drug Regulatory Affairs M.Pharm 2017-2018 (R17) first year first sem is as follows.
M.Pharm. I Year I Sem.
Course Objective: The topics which are present in the Drug regulatory affairs are very much useful which increases the knowledge regarding the regulatory aspects in the pharmaceutical industries.
Course Outcomes:
- Students will come to know the different competent regulatory authorities globally.
- Students be aware of technical aspects pertaining to the marketing authoritization application (MAA)
- The regulatory guidelines and directions framed by the regulatory authorities will be helpful to place the drug products in market for marketing approvals.
UNIT – I : A study of regulatory aspects that affect drug product design, manufacture and distribution in India with special emphasis on the detailed study of the following Acts (with latest amendments)
UNIT – II : The Drugs and Cosmetics Act, 1940 and Rules there under. Recent amendments to Drugs and Cosmetic Act and other relevant rules. Drugs (Price Control) Order in force. Loan license (contract manufacture). Certification and licensing procedures.
UNIT – III : A detailed study of regulatory aspects that affect drug product design, manufacture and distribution in a developed country such as USA and in a developing country such as Brazil, Hatch Waxmann Act; Bolar Provisions and other FDA Regulations. Regulatory aspects of pharmaceutical and bulk drug manufacture, regulatory drug analysis.
UNIT – IV : Documentation related to manufacturing, cleaning methods, retention samples and records, quality control, batch release documents, distribution records, complaints and recalls. Quality, safety and legislation for cosmetic products and herbal products.
UNIT – V : Governing Regulatory Bodies across the globe.
Country Authority Submission
- U.S Food & Drug Administration USDMF
- Canada Therapeutic Product Directorate DMF
- Europe
- European Medicines Agency (EMEA/ National Authorities) EDMF
- European Directorate for Quality of Medicines CEP/COS & Health Care Products
- Product Filing
- Responding Regulatory Deficiencies
- Final Approval Procedure
- Preparation, review, and submission of Drug Master Files to Regulatory Authorities as per their specific requirements.
TEXT AND REFERENCE BOOKS:
- Original laws published by Govt. of India.
- Text Book of Forensic Pharmacy by Mithal B. M.; Vallabh Prakashan, New Delhi.
- Laws of Drugs in India by Hussain.
- Text Book of Forensic Pharmacy by Jain N. K.; Vallabh Prakashan, New Delhi.
- Pharmaceutical Regulatory Affairs – Selected Topics, CVS Subramanyam and J Thimmasetty, Vallabha Prakashan Delhi – 2013
For all other M.Pharm 1st Year 1st Sem syllabus go to JNTUH M.Pharm Pharmaceutical Analysis & Quality Assurance / Quality Assurance 1st Year 1st Sem Course Structure for (R17) Batch.
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