August 27, 2012

MPY204: PMRA Drug Regulatory Affairs-II (International Legislation) Syllabus

MPY204: PMRA Drug Regulatory Affairs-II (International Legislation)

Regulatory Agencies : Requirements of cGMP with specific reference of USFDA (21 CFR part 210 and 211), European Medicines Agency (EMEA) guidelines. Overview of GMP guidelines with specific reference of World health organization (WHO), Medicines and Healthcare products Regulatory Agency (MHRA), Medicines control council (MCC), Therapeutic goods administration (TGA) and ANVISA brazil guidelines.

Product Registration : Requirements for registration of pharmaceutical products into USA with emphasis on para I, II, III & IV filing. Preparation of documents for approval of IND, NDA, ANDA, BLA applications and export registration (USFDA 21 CFR part 310, 312, 314, 320). Preparation of dossier of Drug product and Drug master file.Biowaivers. Understanding the FDA 505(b)(2) Regulatory Approval Pathway, Hatch-Waxman act. Regulatory requirements good laboratory practice in US (USFDA 21 CFR part 58)

ICH Guidelines : with specific reference to stability, analytical validation, impurities, pharmacopeias, specification, quality risk management and pharmaceutical development. Preparation of Common technical document (CTD) as per ICH guidelines, electronic documentation and e-filing (e-CTD).

Industrial Guidelines : Guidance for Industry: IR/ MR Solid Oral Dosage Forms Scale - Up and Postapproval Changes (SUPAC)-Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation 
Guidance for Industry: Sterile/Non Sterile Semisolid Dosage Forms Scale - Up and Postapproval Changes (SUPAC)-Chemistry, Manufacturing and Controls, In Vitro Release Testing, and In Vivo Bioequivalence Documentation

Guidance for Industry : Dissolution testing of immediate release solid oral dosage forms.
Guidance for Industry : Extended release oral dosage forms: Development, evaluation and
application of In Vitro/In Vivo Correlations.
Guidance for Industry : Waiver of In Vivo Bioavailability and Bioequivalence Studies for
Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification
System


Practicals Related to Drug Regulatory Affairs-II (International Legislation)
1. Comparison of dissolution profiles and calculation of F1 and F2 values of tablets of
innovator/standard and generic manufaturers.
2. Comparison of In-vitro release and calculation of F1 and F2 values of semisolid
preparations of innovator/standard and generic manufaturers.
3. IVIVC –through various techniques
4. Preparation dossier of a pharmaceutical product.
5. Experiments to find out the BCS class of pharmaceuticals


Books and References Recommended:
1. Willing, Tuckerman and Hitchings, Good Manufacturing Practices for Pharmaceuticals
2. www.fda.gov
3. www.emea.europa.eu
4. www.picscheme.org

MPY203PMRA: Drug Regulatory Affairs-I (Indian Legislation) Syllabus

MPY203PMRADrug Regulatory Affairs-I (Indian Legislation)

The Drugs and Cosmetics act: Drug & Cosmetic Act : 1940 and Rules with emphasis on Good laboratory practices and requirements of premises and equipments (Schedule L-I), Good manufacturing practices for pharmaceutical products (Schedule M), Drugs (Prices Control) Order 1995, Factory Act, Labor Act, The drug and Magic remedies (Objectionable advertisements) act and rules, 1954.

Product Registration : Requirements for registration of pharmaceutical products into India. Preparation of dossier for product registration as per Indian legislative requirements.

Documentation: Master formula record (MFR), Master formula card (MFC), Batch processing record (BPR), Packaging records, Standard operating procedure (SOP), Site master file, specifications, Certificate of analysis (COA), Material safety data sheet (MSDS), Method of Analysis (MOA), Annual product review, validation protocols, Stability protocol, T- License, forms, maintenance of records in Pharmaceutical industry.

Regulatory requirements: and guidelines for permission to import and/or manufacture of new drugs for sale or to undertake clinical trials (schedule Y).

Intellectual property rights: Patent, copyrights, design and trademark. Effect of GATT and WTO on commerce of pharmaceuticals. Importance of patent, Application, processing of patent, Indian Patent Act 1970 and its latest amendments, United state patent, world patent processing. Patent term extension.


Practicals Related to Drug Regulatory Affairs-I (Indian Legislation)
1. Preparation of SOP’s for operation of manufacturing and analytical equipments.
2. Preparation of MFR, BPR and packaging record for manufacturing of various dosage forms.
3. Validation of mfg. process, equipment, analytical method, disinfectant, and cleaning process.
4. Process validation for various dosage forms.


Books and References Recommended:
1. Vijay Malik, Law relating to Drugs & Cosmetics.
2. The Gazettes of India. The Drug and Cosmetics Act and Rules and its Latest amendments.
3. The Gazettes of India. The Patent Act 1970 and its Latest amendments.
4. www.patentoffice.nic.in
5. www.ep.espace.net
6. www.uspto.gov

MPY202 PMRA : PMRA Pharmaceutical Management-II (Production, Project & Marketing) 2nd sem syllabus

MPY202 PMRA:  Pharmaceutical Management-II (Production, Project & Marketing) syllabus

Production management: Fundamentals of production, organization, economic policy, manufacturing economic, production capacities, production lines and job balancing, visible and invisible inputs, methodology of activities. Development of efficient work methods, quality control and management of R&D. Pharmaceutical quality management system. Production planning and control, production processes- mass job and project; plant location and lay out; work study, materials management-purchase, inventory control and store keeping. Different techniques of inventory management. Productivity management: concepts problems, tools and techniques for improvement. Operation research techniques by PERT and CPM. Consideration for design of large scale manufacturing units including intricate design criteria for units to manufacture sterile and non-sterile products with special reference to tablets, capsule, injections and special dosage forms. Design and development of packaging units including recent advances in packaging techniques
for various types of sterile and non-sterile dosage form. Warehouse design, construction,
maintenance and sanitation; Cost effective design, good warehousing practice.

Project management: Project design and management, preparation of feasibility assessment and selection, project reporting, conventional project appraisal; limitations, towards a new framework. Projections, profitability, cost and benefit analysis, appraisal criteria – financial, economic and social. Risk analysis.

Product Planning: Selection of product, new product development and product differentiation, pricing, promotion – personal selling, salesmanship, qualities of salesman, management of sales force, advertising, publicity and window display, channels of distribution.

Pharmaceutical Marketing: Evolution of marketing concepts; production oriented, sales oriented, promotion oriented and consumer oriented (modern concept); market segmentation; concept of marketing, mix Role of 7P’s (Product, Price, Physical Evidence, Process, People) in Pharmaceutical Marketing Management, corporate planning & strategy, Pharmaceutical industrial marketing management. Pharmaceutical marketing environment. Product management E-Pharma Marketing, Kaisen and six sigma technique.

Marketing Research: Definition and importance, Pharmaceutical Marketing Research Technique, marketing information system, pharmaceutical marketing research area. Database for searching pharmaceutical market of drug products and drug substances Market Demand and Sales Forecasting: Major concept in the demand measurement, estimating current demands, geo-demographic analysis, estimating industry sales, market share and future demand, sales forecasting.

Practicals related to Pharmaceutical Management-II (Production, Project & Marketing)
1. Case studies, market survey, forecasting, reporting
2. Layout designing of manufacturing facilities for various sterile and non-sterile products.
3. Product planning and market research
4. Preparation of product promotional literature and catalogs.


Books and References Recommended:
1. Marketing management by Philip Kotlar; Prentice-Hall of India Ltd., New Delhi
2. Management and Organization by Louis A. Allen; McGraw Hill, Tokyo.
3. Corporate Strategy by Ansoff, H.T. McGraw Hill, New York.
4. Modern Management by Hempran David R.; McGraw Hill, New York.
5. Management by Stoner and Freeman; Prentice Hall, New Delhi
6. Motivation and Personality by Maslow, Abraham, Harper & Row, New York.
7. Management and Organizational Behavior, Utilizing the Human Resources by Harcey, Paul and
Blanchard Kenneth; Prentice Hall of India, New Delhi.
8. Principles and Methods of Pharmacy Management III rd edition Harry A. Smith
9. Management “Global Perspective Heinz Weihrich, Harold Koontz by Tata Mcgraw Hill.
10. Guidelines for Developing National Drug Policies; WHO Publications, 1998.
11. A Guide to Total Quality Management by Kaushik Maitra and Sedhan K. Ghosh.
12. ISO 9000 and Total Quality Management by Sadhan K. Ghosh.
13. Business Organization and Management by Shukla M. C.; S. Chand and Company
14. Personal Management by Filippo E. B. Mac Graw Hill.
15. Marketing Management by Kotler Philip.; Prentice Hall of India.
16. Personal Management Tripathi P. C.; S. Chand and Company.
17. Principle and Practice of Marketing in India by Memoria C. B.
18. Principles of Pharmaceutical Marketing by Mickey Smith, C.B.S Publications.
19. Marketing Hand Book Vol. II, Marketing Management by Edwin- E Bobrow, Mark- D. Bobrow.
20. Financial Management by Johnson, R. W.; The Ronald Press.
21. Project Management by Choudhary, S.; Tata Mac Graw Hill


MPY201: PMRA Pharmaceutical Management-I (General, Personnel & Finance) 2nd Sem Syllabus


Pharmaceutical Management: Meaning, Evolution-scientific, administrative and human relation approach. Process of management: Planning, organizing, staffing, directing, coordinating and controlling- a preliminary idea of concepts, processes and techniques. Fundamental concepts of production, financial, personal, legal and marketing functions with special reference to Pharmaceutical Management. Introduction to budgeting, costing, auditing and budgetary control. Entrepreneurship development.

Understanding Organizations: Meaning, process, types of organization structures and departments, line/staff authority, promoting organizational culture. Organizations, pharmaceutical services and functioning of hospital  pharmacy, bulk drug unit, formulation unit, Ayurvedic and Unani manufacturing units and analytical testing labs etc.

Professional Management: Tasks, responsibilities and skills needed. Leadership, Styles and managing change. Decision Making; Types, procedures, evaluation and selection of alternatives, decision making under various situations.  Management information and decision support systems and time management.

Personnel Management: Job analysis, recruitment, selection, orientation and training, performance appraisal and compensation. Retrenchment, lay off and discharge.
Management of Industrial Relations: Industrial disputes, settlement of disputes through various routes such as bargaining, etc. Motivational aspects, theories of motivation, group dynamics, rewards and incentives, interpersonal skills, significance of communication, its processes, measures for effective communication, conflict management. Stress management, Situational management.

Financial management : Introduction, financial planning and control, working capital management, management of fixed assets. 

Accounting and Finance: Financial accounting, GAAP, cost accounting, budgetary control, valuation of inventory and assets, modern trends, role of internal auditing, internal versus external auditing, accounting control and information system. Evaluation of Investment decisions by Pay back period, accounting rate of return, net present value methods, break even analysis.


Practicals related to Pharmaceutical Management-I (General, Personnel & Finance)
1. Case studies, analysis and report preparation based on the theory.
2. Preparation of ledger and balance sheet.

Pharmaceutical Management & Regulatory Affairs(PMRA) 2nd sem. Syllabus

M. PHARMA. 2nd SEMESTER SYLLABUS (branch-wise)



Drug Regulatory Affairs(DRA) Syllabus-II sem

Pharmaceutical Chemistry  Syllabus-II sem

Pharmaceutical Biotechnology Syllabus-II sem

Pharmaceutical Analysis  Syllabus-II sem

Quality Assurance  Syllabus-II sem

Pharmaceutics  Syllabus-II sem

Pharmacognosy  Syllabus-II sem

Pharmacology Syllabus-II sem

August 9, 2012

PRODUCT DEVELOPMENT AND FORMULATION (MPY- 104) SYLLABUS



Theory
1. Preformulation studies: Study of physical, chemical and
pharmaceutical factors influencing formulation of drugs.

2. Formulation additives: Study of formulation additives, Drug – Excipient, Excipient - Excipient interactions and Incompatibilities.

3. Solubilization: Theory of solubilization, methods of solubility enhancement and factor influencing solubility. Solids dispersion.

4. Dissolution Technology: Design of dissolution apparatus, dissolution media, dissolution testing of different types of dosage formulations, data interpretation, in-vitro and in-vivo correlation.

5. Tablets: Recent advances in tablet technology and automation in manufacturing process, formulation and evaluation of dispersible, effervescent, floating and multilayers tablets.

6. Formulation consideration and evaluation: Parenterals and Ophthalmics.

7. Polymers: Classification, General method of synthesis, Properties, Characterization, Evaluation and Application in pharmacy. A detail account of biodegradable polymers.

8. Nutraceuticals: Introduction, formulations, uses, recent developments and law governing nutraceuticals.

9. Pharmaceutical packaging: Packaging materials, type and tests of containers and closures, Pilot plant scale up technique.

10. Drug stability: Stability study programmes for formulations. Determination of Expiry date (shelf life) and Overage calculations. Stability indicating assays and ICH guidelines for stability.

11. OptimizationTechniques: Computers in pharmacy, Optimization techniques, Computer aided drug formulations.


Books and References Recommended:
1. Swarbrick, J. and Boyran, J. C., Encyclopedia of Pharmaceutical Technology” Vol.1-3, Marcel Dekkar, Inc., New York.
2. Gennaro, A.R., Remington’s “The Science and practice of
Pharmacy”, Lippincot, Wiliams & Wilkins, Philadelphia.
3. Aulton, M.E., “Pharmaceutics- The science of doses form design”, Churchill Livingstone, London.
4. Carstersen, J.T., “Drug stability: Principal & practice”, Marcel Dekker, Inc., NY
5. Banker and Rhodes, Modern Pharmaceutics. Marcel Dekker Inc. NY.
6. Liium, L. and Davis, S.S., “Polymers in controlled drug delivery”, Wright Bristol.
7. Kibbe, “ Hand book of Pharmaceutical Excipients., Pharmaceutical Press, London.
8. Lachmen, L. & Lieberman, H.A., “ Theory and Practice of Industrial Pharmacy”, Verghese publishing house, Bombay.
9. Martin, Physical Pharmacy.
10. Lieberman, H.A. & Lachmen, L., “ Pharmaceutical Dosage forms – Dispersed Systems’’ Vol.1-3 ,Marcel Dekker, Inc., NY.
11. Avise, K. E. & Lachmen, L., “ Pharmaceutical Dosage forms – “Parenteral Medications’’ Vol.1-3 ,Marcel Dekker, Inc., NY.
12. Lieberman, H.A. & Lachmen, L., “ Pharmaceutical Dosage forms – Tablets’’ Vol.1-3 ,Marcel Dekker, Inc., NY.
13. Yalkowsky,S.H.” Techniques of Solubilization of drugs”, Marcel Dekker, Inc., NY.

DRA, INTELLECTUAL PROPERTY RIGHTS AND QUALITY ASSURANCE (MPY -103) SYLLABUS


DRA, INTELLECTUAL PROPERTY RIGHTS AND QUALITY ASSURANCE (MPY -103) SYLLABUS


Theory
1. Requirements of GMP, CGMP, GLP, USFDA, WHO guidelines and ISO 9000 Series.

2. Drugs and Cosmetics Acts and Rules, Drug Regulatory Affairs.

3. Documentation – Protocols, Forms and Maintenance of records in Pharmaceutical industry.

4. Clinical Trials and toxicological evaluation of drugs. Preparation of documents for New Drug Approval and Export Registration.

5. Processing and its application, Intellectual Property Rights (Patent, Copy right and Trade marks).

6. Sewage disposal and Pollution control.

7. Concepts in Validation, Validation of manufacturing, Analytical and Process validation and its Application.

8. Basic concept of Quality Control and Quality Assurance systems, Source and Control of Quality variation of Raw materials, Containers, Closures, Personnel, Environmental, etc.

9. In process quality control tests, IPQC problems in Pharmaceutical industries. ICH Guidelines

10. Sampling plans, Sampling and Characteristic curves.

11. Master formula generation and Maintenance, Standard Operating Procedure (SOP) for different dosage forms.

Books and References Recommended:
1. Willing, Tuckerman and Hitching, Good Manufacturing Practices for Pharmaceuticals.
2. Drugs and Cosmetic Acts and Rules.
3. Bharathi, Drugs and Pharmacy Laws in India.
4. Patel, Industrial Microbiology.
5. Loftus, B.T. and Nash,R.A., Pharmaceutical Process Validation.
6. Bolton, S., Pharmaceutical Statistics.
7. Banker, G.S. and Rhodes, C.T., Modern Pharmaceutics.
8. OPPI, Quality Assurance.
9. Carletiori, Validation of Aseptic Pharmaceutical Process.
10. Garfield, Quality Assurance Principles for Analytical Laboratories.
11. Indian Pharmacopoeia.
12. British Pharmacopoeia.
13. United State Pharmacopoeia.

BIOTECHNOLOGY & BIOINFORMATICS (MPY 102) SYLLABUS

BIOTECHNOLOGY & BIOINFORMATICS (MPY 102) SYLLABUS


1. Genetics: Structure & Function of DNA, DNA Replication & Repair, Expression of Genetic Information: Structure & Function of RNA, Transcription, Genetic code, Translation, Post translational modification.

2. Recombinant DNA Technology: Constructing Recombinant DNA molecules Restriction enzymes, Vectors, Gene Cloning, Genomic libraries, Polymerase Chain reaction – based DNA cloning, Restriction mapping, Blotting techniques, DNA sequencing, Pharmaceutical applications of recombinant DNA.

3. Gene Therapy: General Introduction, Potential target diseases for Gene therapy, Gene transfer methods, Clinical studies, Pharmaceutical production & Regulation.

4. Basics of Immunology, Monoclonal antibodies & Hybridoma technology & its Applications. Vaccines – Conventional vaccines, Modern Vaccine technologies, Genetically improved live vaccines, Genetically improved subunit vaccines, Pharmaceutical considerations.

5. Fundamentals of Cell biology: Cell organization and plasma membrane: Transport of
substances across the membrane. Cellular reproduction: The Cell cycle, Mitosis & Meiosis,
Apoptosis. Cell Signaling: Communication between cells and their environment

6. Molecular biology of cancer: Causes of Cancer & Genetics of Cancer, New strategies for combating cancer.

7. Molecular, Structural and Chemical Biology in pharmaceutical research: Molecular biology of disease and invivo transgenic models, Genomic protein targets and recombinant therapeutics, Structural biology and rational drug design, Chemical biology and Molecular diversity, Gene therapy & DNA/ RNA targeted therapeutics. Future of pharmaceutical
research.

8. Introduction to Bioinformatics: Biological databases, Sequence analysis, Protein structure, Genetic and physical mapping, Application of bioinformatics in pharmaceutical industries.

9. Biostatistics – Graphical representation of Data, Descriptive statistics, Normal distribution, Probability distribution, Sampling & Sampling plans.

Recommended Readings
1. Lehninger ., Principles of Biochemistry
2. Karp, G.,Cell & Molecular Biology.
3. Crommelin, D.J., A., and Sindelar R.D., Pharmaceutical
Biotechnology.
4. Templeton N.S., and Lasic. D.D., Gene Therapy.
5. Benjamin Lewin, Genes.
6. Watson and Trooze, Recombinant DNA Techniques
7. Lesk., Introduction to Bioinformatiics.
8. Watson, Molecular Biology of cell.
9. Old and Primrose, Principles of Gene Manipulations.
10. Watson, J.D., Gilman, M., Recombinant DNA Technology
11. Baxevanis, A.D., Frana, Duelette, B.F.,Bioinformatics
12. Alberts, B., Johnson, A., Lewin, J., Raff, M., Roberts, K., Walter, P.,
molecular biology of the cell
13. Paul, W.E, Fundamentals of Immunology
14. Klug, W.S., Cummings, M.R., Essentials of Genetics
15. Glick, B.R., Pasternak, J.J., Molecular Biotechnology
16. Walker, J.M., Ripley, R., Molecular biology and Biotechnology
17. Bolton, S., Pharmaceutical Statistics.

MASTER OF PHARMACY SYLLABUS


M. PHARMA. 1st SEMESTER SYLLABUS (common for all branches)


M. PHARMA. 2nd SEMESTER SYLLABUS (branch-wise)

 

M. PHARMA. 3rd SEMESTER SYLLABUS (branch-wise)

 

M. PHARMA. 4th SEMESTER SYLLABUS (branch-wise)

 

 

MODERN ANALYTICAL TECHNIQUES (MPY 101) SYLLABUS

MODERN ANALYTICAL TECHNIQUES (MPY 101) SYLLABUS

Theory

1. Theory, Instrumentation, Methods and Applications of VU Spectrophotometer.

2. Theory and Instrumentation of IR and FT-IR, its advantage and applications in Structural elucidation.

3. NMR, C13 NMR, Origin of spectra, Chemical shifts, Spin-spin coupling,
Coupling constant, Instrumentation and application for Structural elucidation.

4. Mass spectra, Instrumentation, Fragmentation pattern and applications
for Structural elucidation. Application of GC-Mass, HPLC-Mass for complex mixtures.

5. Theory, Instrumentation and application for the following:
i) Fluorescence
ii) X – Ray crystallography
iii) Atomic spectroscopy
iv) Ultra centrifugation
v) ESR
vi) Liquid Scintillation spectrometry
vii) Auto radio grapy

6. Separation Techniques; Fundamental principles, Basic instrumentation, Qualitative and Quantitative Pharmaceutical applications of Gas-liquid Chromatography, HPLC, HPTLC, 
Gel Chromatography, Electrophoresis and Ion-pair Chromatography.

7. General Principle, instrumentation and application of optical 
rotatory dispersion (ORD) and Circular dichroism (CD).

8. Immunoassay Techniques: Enzyme and Radioimmunoassay
techniques. Theory, Methods and applications.

9. Thermal methods: Thermo Gravimetry (TG), Differential Scanning 
Calorimetry (DSC), Differential Thermal Analysis (DTA).

10. Principles and application of light, Phase contrast, Scanning and
Transmission electron microscopy, Cytometry and Flow cytometry.


Books and References Recommended:

1. Florey, Analytical Profiles of Drugs, Vol.1-16.
2. Sinder, Text Book of HPLC.
3. McLafferty, Mass Spectrometry.
4. Rao,C.N., Ultraviolet Visible Spectroscopy for Chemical Application.
5. Silverstein, Basseler, Morril, Spectophotometrc Identification of Organic
Compounds.
6. Rao,C.N., Chemical Application of Infrared Spectroscopy.
7. Weissberger, Physical Methods in Organic Chemistry.
8. Kiencz, B. and Dierasi, C., Interpretation of Mass Spectra of Organic
Compounds.
9. Jackmann, Application of NMR Spectra to Organic Compounds.
10.Willard, Merrit and Dean, Instrumental Methods of Analysis.
11. Elliel, E.L., Stereochemistry of Carbon Compounds.
12. Naahod, P., Physical Methods of Structure Determination.
13. Stahl, Thin Layer Chromatography.
14. Ewing, Instrumental Methods of Chemical Analysis.
15. Block and Durrum, Paper Chromatography and Electrophoresis.
16. Remington’s Pharmaceutical Sciences.
17. Sirmer, Spectroscopic Analysis.

M. PHARMA. 1st SEMESTER SYLLABUS (common for all branches)

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