Pharmaceutical manufacturing technology Detailed Syllabus for Pharmaceutical Quality Assurance M.Pharm first year second 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 Pharmaceutical manufacturing technology M.Pharm 2017-2018 (R17) first year second sem is as follows.
M.Pharm. I Year II Sem.
Course Objectives: This course is designed to impart knowledge and skills necessary to train the students with the industrial activities during Pharmaceutical Manufacturing.
Course Outcomes: At completion of this course it is expected that students will be able to understand,
- The common practice in the pharmaceutical industry developments, plant layout and production planning
- Will be familiar with the principles and practices of aseptic process technology, non sterile manufacturing technology and packaging technology.
- Have a better understanding of principles and implementation of Quality by design (QbD) and process analytical technology (PAT) in pharmaceutical manufacturing
UNIT I : Pharmaceutical industry developments: Legal requirements and Licenses for API and formulation industry, Plant location- Factors influencing. Plant layout: Factors influencing, Special provisions, Storage space requirements, sterile and aseptic area layout. Production planning: General principles, production systems, calculation of standard cost, process planning, routing, loading, scheduling, dispatching of records, production control.
UNIT II : Aseptic process technology: Manufacturing, manufacturing flowcharts, in process-quality control tests for following sterile dosage forms: Ointment, Suspension and Emulsion, Dry powder, Solution (Small Volume & large Volume). Advanced sterile product manufacturing technology : Area planning & environmental control, wall and floor treatment, fixtures and machineries, change rooms, personnel flow, utilities & utilities equipment location, engineering and maintenance. Process Automation in Pharmaceutical Industry: With specific reference to manufacturing of sterile semisolids, Small Volume Parenterals & Large Volume Parenterals (SVP & LVP), Monitoring of Parenteral manufacturing
facility, Cleaning in Place (CIP), Sterilization in Place (SIP), Prefilled Syringe, Powdered Jet, Needle Free Injections, and Form Fill Seal Technology (FFS). Lyophilization technology: Principles, process, equipment.
UNIT III : Non sterile manufacturing process technology: Manufacturing, manufacturing flowcharts, in processquality control tests for following Non-Sterile solid dosage forms: Tablets (compressed & coated), Capsules (Hard & Soft). Advance non-sterile solid product manufacturing technology: Process Automation in Pharmaceutical Industry with specific reference to manufacturing of tablets and coated products, Improved Tablet Production: Tablet production process, granulation and pelletization equipments, continuous and batch mixing, rapid mixing granulators, rota granulators, spheronizers and marumerisers, and other specialized granulation and drying equipments. Problems encountered. Coating technology: Process, equipments, particle coating, fluidized bed coating, and application techniques. Problems encountered.
UNIT IV : Containers and closures for pharmaceuticals: Types, performance, assuring quality of glass; types of plastics used, Drug plastic interactions, biological tests, modification of plastics by drugs; different types of closures and closure liners; film wrapper; blister packs; bubble packs; shrink packaging; foil / plastic pouches, bottle seals, tape seals, breakable seals and sealed tubes; quality control of packaging material and filling equipment, flexible packaging, product package compatibility, transit worthiness of package, Stability aspects of packaging. Evaluation of stability of packaging material.
UNIT V : Quality by design (QbD) and process analytical technology (PAT): Current approach and its limitations. Why QbD is required, Advantages, Elements of QbD, Terminology: QTPP. CMA, CQA, CPP, RLD, Design space, Design of Experiments, Risk Assessment and mitigation/minimization. Quality by Design,Formulations by Design, QbD for drug products, QbD for Drug Substances, QbD for Excipients, Analytical QbD. FDA initiative on process analytical technology. PAT as a driver for improving quality and reducing costs: quality by design (QbD), QA, QC and GAMP. PAT guidance, standards and regulatory requirements.
REFERENCES:
- Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial pharmacy, 3rd ed., Varghese Publishers, Mumbai 1991.
- Sinko PJ. Martin’s physical pharmacy and pharmaceutical sciences, 5th ed., B.I. Publications Pvt. Ltd, Noida, 2006.
- Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical dosage forms:tablets Vol. I-III, 2nd ed., CBS Publishers & distributors, New Delhi, 2005.
- Banker GS, Rhodes CT. Modern Pharmaceutics, 4th Inc, New York, 2005. ed., Marcel Dekker
- Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good manufacturing of pharmaceuticals (A Plan for total quality control) 3rd Edition. Bhalani publishing house Mumbai.
- Indian Pharmacopoeia. Controller of Publication. Delhi, 1996.
- British Pharmacopoeia. British Pharmacopoeia Commission Office,London, 2008.
- United States Pharmacopoeia. United States Pharmacopeial Convention, Inc, USA, 2003.
- Dean D A, Evans E R and Hall I H. Pharmaceutical Packaging Technology. London, Taylor & Francis, 1st Edition. UK.
- Edward J Bauer. Pharmaceutical Packaging Handbook. 2009. Informa Health care USA Inc. New york.
- Shaybe Cox Gad. Pharmaceutical Manufacturing Handbook. John Willey and Sons, New Jersey, 2008.
For all other M.Pharm 1st Year 2nd Sem syllabus go to JNTUH M.Pharm Pharmaceutical Quality Assurance 1st Year 2nd Sem Course Structure for (R17) Batch.
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