JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

This course is designed to impart fundamental knowledge on documentation

and general principles involved in regulatory writing and submission to agencies.

Course Outcomes

Upon completion of the course the student shall be able to,

• Know the various documents pertaining to drugs in pharmaceutical industry
• Understand the basics of regulatory compilation
• Create and assemble the regulation submission as per the requirements of agencies
• Follow up the submissions and post approval document requirements

UNIT - I

Documentation in pharmaceutical industry: Exploratory Product Development Brief (EPDB) for Drug substance and Drug product, Product Development Plan (PDP), Product Development Report (PDR), Master Formula Record, Batch Manufacturing Record and its calculations, Batch Reconciliation, Batch Packaging Records, Print pack specifications, Distribution records, Certificate of Analysis (CoA), Site Master File and Drug Master Files (DMF).

UNIT - II

Dossier preparation and submission: Introduction and overview of dossiers, contents and organization of dossier, binders and sections, compilation and review of dossier. Paper submissions, overview and modules of CTD, electronic CTD submissions; Electronic submission: Planning electronic submission, requirements for submission, regulatory bindings and requirements, Tool and Technologies, electronic dossier submission process and validating the submission, Electronic Submission Gateway (ESG). None CTD electronic submissions (NeeS), Asian CTD formats (ACTD) submission. Organizing, process and validation of submission. Submission in Sugam system of CDSCO.

UNIT - III

Audits: Introduction, Definition, Summary, Types of audits, GMP compliance audit, Audit policy, Internal and External Audits, Second Party Audits, External third-party audits, Auditing strategies, Preparation and conducting audit, Auditing strategies, audit analysis, audit report, audit follow up. Auditing/inspection of manufacturing facilities by regulatory agencies. Timelines for audits/inspection. GHTF study group 4 guidance document. ISO 13485.

UNIT - IV

Inspections: Pre-approval inspections, Inspection of pharmaceutical manufacturers, Inspection of drug distribution channels, Quality systems requirements for national good manufacturing practice inspectorates, inspection report, model certificate of good manufacturing practices, Root cause analysis, Corrective and Preventive action (CAPA).

UNIT - V

Product life cycle management: Prior Approval Supplement (PAS), Post Approval Changes [SUPAC], Changes Being Affected in 30 Days (CBE-30), Annual Report, Post marketing Reporting Requirements, Post approval Labeling Changes, Lifecycle Management, FDA Inspection and Enforcement, Establishment Inspection Report (EIR), Warning Letters, Recalls, Seizure and Injunctions. ISO Risk Management Standard

R19 M.PHARM PHARMACEUTICAL REGULATORY AFFAIRS

TEXT AND REFERENCE BOOKS:

• 1. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury and Gil Bismuth, Interpharm/CRC, Boca Raton, London New York, Washington D.C.
• 2. Pharmaceutical Manufacturing Handbook, Regulations and Quality by Shayne Cox Gad. Wiley- Interscience, A John Wiley and sons, Inc., Publications.
• 3. Handbook of microbiological Quality control. Rosamund M. Baird, Norman A. Hodges, Stephen
• 4. P. Denyar. CRC Press. 2000.
• 5. Laboratory auditing for quality and regulatory compliance. Donald C. Singer, Raluca-loana Stefan, Jacobus F. Van Staden. Taylor and Francis (2005).
• 6. Implementing Juran's Road Map for Quality Leadership: Benchmarks and Results, By Al Endres, Wiley, 2000
• 7. Understanding, Managing and Implementing Quality: Frameworks, Techniques and Cases, By Jiju Antony; David Preece, Routledge, 2002
• 8. Organizing for High Performance: Employee Involvement, TQM, Reengineering, and Knowledge Management in the Fortune 1000: The CEO Report By Edward E. Lawler; Susan Albers Mohrman; George Benson, Jossey-Bass, 2001
• 9. Corporate Culture and the Quality Organization By James W. Fairfield- Sonn, Quorum Books, 2001
• 10. The Quality Management Sourcebook: An International Guide toMaterials and Resources By Christine Avery; Diane Zabel, Routledge, 1997
• 11. The Quality Toolbox, Second Edition, Nancy R. Tague, ASQ Publications
• 12. Juran's Quality Handbook, Sixth Edition, Joseph M. Juran and Joseph A. De Feo, ASQ Publications
• 13. Root Cause Analysis, The Core of Problem Solving and Corrective Action, Duke Okes, 2009, ASQ Publications
• 14. International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) R19 M.PHARM PHARMACEUTICAL REGULATORY AFFAIRS M.Pharm I Year I Sem (Pharmaceutical Regulatory Affairs)