Recommended Syllabus For Selective Subject for Semester VII and VIII Subject: Industrial Pharmacy

1. Bulk drug manufacturing: Bulk drug Manufactures, Types of Reactions in Bulk drug Manufacture and Processes. Specil Requirements for Bulk Drug Manufacture, Regulatory aspects of pharmaceutical and bulk drug manufacture, Regulatory drug analysis. 2: Quality management: Concept of Total Quality Management, Philosophy of GMPS. General provisions related to finished pharmaceuticals: Building & facilities, Equipments,,Containers & closures, Production & process control, Packaging & labeling controls, Records & reports. GLP: What is good laboratory practice, Principles of good laboratory practice, Laboratory Accreditation and GLP Compliance, Documentation, Records and the Preparation of SOPs, Calibration of measuring equipment and Measurement Uncertainty, Quality control of laboratory tests, Internal Quality Audits, Use of computers in the laboratory, General good testing conduct, Handling of test items, Selection and training of staff, The laboratory environment, Housekeeping & hygiene 3. Process Validation: Regulatory basis, Terminology: validation, qualification, calibration. Prospective process validation, Retrospective validation, Validation of sterilization processes (Heat & Filtration), Qualification of water systems, Qualification of Air-Handling systems, Qualification of Equipments, Validation & verification of cleaning process. Validation of Laboratory test methods 4. Drug Reagulatory Affairs( formulations and API): Introduction to RA profession, ICH Quality guidelines, DMF preparation in CTD format, APIRegulatory submissions to USFDA, EDQM & EMEA, API-Regulatory submissions to WHO, Brazil, Canada and Japan, Formulation development, pre-formulation studies & reverse engineering, Patents from regulatory perspective, Dossier preparation in CTD format, Regulatory Systems in US, ANDA submissions, handling post approval changes , Regulatory Systems in Europe, filing procedures, handling variation, Drug Registration with semi-regulated countries , Handling deficiencies from Drug Regulatory Authorities , Facing GMP audits and regulatory inspections, eCTD submissions Recommended books: The Pharmaceutical Regulatory Process, 2nd ed. Ira R. Berry, Robert P. Martin Medical Product Regulatory Affairs: Pharmaceutical , Diagnostics, Medical Devices John J. Tobin and Gary Walsh FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices andBiologics, 2nd ed. Douglas J. Pisano and David S. Mantus Good Drug Regulatory Practices: a Regulatory Affairs Quality Manual (Good DrugDevelopment Series) Helene I. Dumitriu How to practice GMPs; P.P.Sharma, 5th Edition, Vandhana Publications, New Delhi. Pharmaceutical process validation, Bernard T. L. and Robert A. Nash, Volumes 23,Marcel Decker. Good Manufacturing Practice for pharmaceuticals, Sidney H. Willing, MercelDecker Inc. Validation of Pharmaceutical Process, James Agalloco, 3rd Edition, Infroma Healthcare USA Validation of Pharmaceutical Processes, Sterile Products, F.J.Carleton, MarcelDekker Inc. Guidelines on cGMP & Quality of Pharmaceutical Products, S. Iyer, D.K. Publication,Mumbai. Validation in Pharmaceutical Industry (Concept, Approches & Guidelines), P.P.Sharma, Vandhana Publications, New Delhi