DR.

BABASAHEB AMBEDKAR MARATHWADA UNIVERSITY AURANGABAD

SYALLABUS OF MASTER OF PHARMACY

QUALITY ASSURANCE

Name: Vijayanand G Bawane M. Pharm. (Q. A.)

ELIGIBILITY CRITERIA AND RULES (M. Pharm- Quality Assurance) AIMS AND OBJECTIVES: The aim of postgraduate course in Quality Assurance is to 1. Train specialist who can be effective teachers,pharmaceutical experts and research workers 2. In the specialized fields of pharmacy. Such specialists can also offer following services to the society i) Pharmaceutical manufacturing ii) Product development iii) Standardization of drugs iv) Total quality management v) Drug regulatory affairs vi) Drug information services vii) Research and development viii) Pharmaceutical education ix) Pharmaceutical management and marketing DURATION AND COURSE: M.Pharm. Sem I : 6months M.Pharm. Sem II : 6months M.Pharm. Sem III : 6months M.Pharm. Sem iv : 6months ELIGIBILITY: O.M. Pharm. 1. : A student holding Bachelor of Pharmacy degree of Dr. Babasaheb Amebedkar Marathwada University or any other university recognized as equipment there to is eligible for admission to postgraduate course in the subject of quality Assurance. The candidate should have minimum 60% marks at the bachelors degree as awarded by the respective university. In case of SC and St category the minimum percentage required is 55% in degree as awarded by respective university. O.M. Pharm. 2. : Examinees who have passed in all subjects prescribed for M.Pharm. Sem. I, II, III, IV examination shall be eligible for the degree of Master of Pharmacy in which they have passed. R.M. Pharm.1. : a. An examinee shoul;d obtain 59% of marks to pass the subject. b. Those obtaining 70% or more in aggregate shall be placed distinction, those obtaining 60% and above but less than 70% or more in aggregate shall be placed in first class and all other successful examinees in second class. The names of examinees passing the examination as whole in the minimum prescribed period and obtaining the prescribed number of places in the first class that arranged in order of merit, irrespective of the subject offered at the M. Pharm. Examination as provided I the examination. Candidate passing examination by taking exemption in the subject shall be declared pass in pass class R.M. Pharm.2. : a. There shall be four semesters during M. Pharm. Each of 6 months duration. In first three semesters there shall be three components theory,practical and dissertation. In fourth semester there shall be dissertation work only. b. There shall be three parts of the examination and one part of dissertation work leading to degree of Master of Pharmacy in Quality Assurance. The examination for the I, II, III, parts of M.Pharm. in Quality Assurance shall be held in December/ January, May/June and December/January respectively at such places and on such dates as may be prescribed by the university authority.

c. Subject to his/her compliance with the provision of the regulations and other ordinance in force form time to time an application for admission at the end of semester of study to an examination specified in column 1 of the table 1 shall be eligible to appear at it if. i. He/She satisfies the condition specified in the table 1 and provisions in the regulations. ii. He/She satisfies the other conditions given in the universities ordinanace enforced. iii. He/She as persecuted regular course of study in the institute for the examination during the particular semester iv. He/She as in the opinion of the college and research guide shown satisfactory progress in the academic work

Course structure and scheme of evaluation (Semester-wise, along with curiiculum details) Name of subjects Hrs/Week Evaluation(Marks) C L T P I External Tota l T P SEM I M11:Reaserch 2 40 60 100 Methodology M12:Quality Assurance 2 40 60 100 Techniques-I M13: Advance Analytical 2 40 60 100 Techniques ML1: Comprehensive 20 80 200 Laboratory Techniques MA1: (Problem selection 6 50 120 50 and literature survey) Total 550

Name of subjects L SEM II M21: Quality Assurance Techniques-II M12:Quality Assurance Techniques-III ML2: Comprehensive Laboratory Techniques MA1: Literature survey and Problem feasibility Seminar: II Seminar: III

Hrs/Week T P

Evaluation(Marks) External Total T P 60 60 150 100 100 250 50

2 3 25

40 40 100 50 06 25 25 Total

25 25 550

Name of subjects L SEM III M21: Drug Regulatory Affairs M12:Quality Assurance Techniques-III ML3: Comprehensive Laboratory Techniques MA1: Work Progress Seminar: IV Seminar: V

Hrs/Week T P

Evaluation(Marks) External Total T P 60 60 180 100 100 300

2 2 30

40 40 120

04 25 25 Total 25 25 550

Name of subjects L SEM IV MA1: Dissertation Work; Thesis MA1: (Problem selection and literature survey)

Hrs/Week T P

Evaluation(Marks) External Total T P --150 100 200 150 350 2000

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50 50

Total Grand Total

M11: RESEARCH METHODOLOGY (Theory 2 Hours/Week)

I.

II.

RESEARCH 1 Meaning of research, purpose of research and types of research (clinical, experimental, basic, applied, patent and oriented research) objectives of research (4hrs). 2 Literature survey: using library , books and journals, MEDLINE-internet getting patents and reprints of articles as sources for literature survey. 3 Selecting a problem and preparing a research proposal for different types of research sources of procurement of grants. 4 Methods and tools used in research o Research design (features of good design, types of research design, basic principles of research design). o Qualitative studies and Quantitative studies. Simple data organization, descriptive data organization Limitation and sources of errors. Enquiries in the form of questionnaires, opinionaries and interviews. Statistical analysis of data including variance, standard deviation, student t test and ANOVA, correction of data and its interrelation, computer data analysis, bio-statistics of clinical trials. Scientific methods of medicine. Scientific equations of therapy. 5 Documentation Importance of documentation in case of research record and GMP/GLC Techniques of documentation in case of research record and GMP/GLP Uses of computer packages in clinical trials Documentation in clinical trials. 6 Research report / paper writing /thesis writing /poster presentation. Different parts of research report /paper. Title-title of project with authors name. Abstract statement of problem, background list in brief, purpose and scope. Key words. Methodology subject, apparatus, instruments and procedures. Results tables, graphs, statistical presentation. Discussions support or non-support of hypothesis. Practical and theoretical implications. Acknowledgements. References. Errata. Importance of spell check. Use of footnotes. PRESENTATION: Importance, types, different skills.

Content of presentation format of model, introduction and endings. Posture, gesture, eye to eye contact, facial expression, storage fright. Volume, pitch, speed, pauses and language. Visual aids and seating arrangements Question and answer sessions. III. INTELLECTUAL PROPERTY WRITES. Protection of patents and trademarks and design and copyrights and patent system in India. Present status of IPR, future changes expected in Indian patents. What may be patented Who may apply for patent. Preparation of patent proposal Registration of patent in India and foreign countries and vice-versa. ICh guidelines for clinical trials, therapeutic drugs and bioequivalence Exclusive marketing rights Black box IPOr and IDMA views on patents. Human health and patent laws, latent lethality. GATT,TRIPES. IV. COST ANALYSIS OF PROJECTS AND CLINICAL TRIALS Industrial projects- their feasibility reports. V. INDUSTRIAL INSTITUTE INTERACTION. VI. FUNDS IN RESEARCH. VII. PRACTICAL WORKS: Preparation of research proposal for a scientific problem and assessment. Recommended books: 1. Research in education john. W. Best, Jems.V. Kahn. 2. Research methodology- C R Kokari. 3. Methodology and techniques of social research Wilkinson and Bhandarkar 4. Presentation skills Michel Halton _ Indian society for institute education. 5. Practical introduction to copyrights- Gavine Mofariane. 6. Thesis projects in scienc3e and engineering Richard. M. Davis. 7. Scientists in Legal Systems Ann Labor Science. 8. Thesis and Assessment writing _ Janolthon Anderson. 9. Writing a Technical paper Donald Manzel. 10. Effective business report writing lel and Brown. 11. Protection of Industrial Property Rights Purshottam Das and Gokul Das. 12. Spelling for millions edna Furmess. 13. Preparation for Publications King Edwords Hospital Foundation for London. 14. Information Technology The Hindu Speeks. 15. Documentation Genesis and Devlopment 3792. 16. Ayurveda and Modern Medicine - R.D. Lele. 17. How to write and publish a scientific paper Reoport A Day, Cambridge University Press 4th edition 1994 18. Lecture notes on patent TIFAC: DOC: 022, TIFAC July 2002

M12 : QUALITY ASSURANCE TECHNIOQUES- I (Theory 2 Hours / Week) 1. Introduction: an understanding of the concepts of Quality Assurance, Good Manufacturing Practices and Quality Control as applied to the Pharmaceutical Industry. 2. Related Quality Systems ISO, WHO etc and their applications in Pharmaceutical Industry. 3. Documentation related to Pharmaceutical Industry. a. New application : NDA and ANDA requirements, data presentation, verification and grant of approval by FDA b. Manufacturing Documents. BMR, routine records, downtime records, calibration and validation records. c. Quality Assurance Documents: Validation and types of validation, protocols, methodology and related GMP/ICH guidelines. d. Quality Assurance Documents: Internals audits, SOP documents, security and related issues e. Store Management Documents : Stock reconciliation, records for raw materials, finished products and packaging materials f. Maintenance and Environment control related documents g. Consumer related Documents : product recall, complaint tracebility, printed packing, preventive maintenance records 4. Good Laboratory Practices (GLP) Regulation, biological evaluation, microbiological limit tests, sterility tests, tests for effectiveness of antimicrobial preservative, LD50, ED50, teratogenicity, mutagenicity, clinical trials, bioassays, pyrogens, pyrogenicity, safety testing, presentation of related data and supporting raw data. 5. References and Working standards, sources, preparation, characterization, uses, storage records. Recommended books: 1) 2) 3) 4) 5) 6) 7) 8) Good Laboratory Practice Regulations; S. Weinberg; Marcel and Dekker Encyclopedia of Pharmaceutical Technology; J Swarbrick, Boylan; Marcel and Dekker Pharmaceutical Process Validation; J. R. Berry; R. A. Nash; Marcel and Dekker Good Manufacturing Practises for Pharmaceutics; S. H. Will, J. R. Stoker; Marcel and Dekker Design of experiments for process improvement and Quality Assurance; R.F. Brewer, Narrosa ISO 14000 & ISO 9000, B. Othary; Gower Understanding ISO 9000 and implementing the basics to Quality; D. H. Stamantis; Marcel and Dekker Pharmaceutical Master Validation Plan The Masterguide to FDA, GMP, GLP, Complience; Syed Imtiaz Hyder, St Lucle Press

ML1: QUALITY ASSURANCE TECHNIQUES I Practical 1. 2. 3. 4. Quantitative and Qualitative estimation of drugs / active chemical substances Microbial limit tests for starch, acacia, antacid preparation Sterility testing of medical devices, LVP, antibiotics, ophthalmic preparations Designing of following documents site master file, SOP, MPER, BPER, change contract format, product compliant document, internal audit document, product recall document, IPQC document, material receipt, sampling, dispensing and storage document

M13 ADVANCE ANALYTICAL TECHNIQUES 1. Spectroscopic method : Theory, instrumentation, chemical application and structural elucidation by UV, IR, NMR, C13 NMR, Mass spectroscopy, ESR and Emission spectroscopy. 2. Separation Techniques : Fundamental principles, theory, instrumentation and application of gas-liquid chromatography, HPLC, gel chromatography, GC-MS, HPTLC and ion pair chromatography. 3. Thermal Analysis: Theory, Instrumentation and application of thermo gravimetric analysis (TGA) and differential thermal analysis (DTA)

M21: QUALITY ASSURANCE TECHNIQUES II (Theory 2 Hours / Week) 1. An approach to development of analytical method. 2. Analytical methods used for excipients. 3. Analysis of drugs metabolites in biological fluids e.g. urine, blood, tissue, enzymatic analysis 4. Biochemical analysis of drugs, estimation of enzymes & other endogenous material. 5. Microbiological assays of antibiotics, vitamins, immunological assays-ELISA, immunoblotting, immunoflouricsence, immunoaffinity. 6. WHO guidelines of standardization of herbal raw materials and finished products. 7. Standardization of food products. 8. Analysis of biotech products/ proteins. Recommended books : 1. Good Laboratory Practice Regulation; S. Weinberg; Marcel and Dekker 2. Encyclopedia of Pharmaceutical Technology; J. Swarbrick, Boylan; Marcel and Dekker 3. Pharmaceutical Process Validation; J. R. Berry; R. A. Nash; Marcel and Dekker 4. Good Manufacturing Practices for Pharmaceutics; S. H. Will, J. R. Stoker; Marcel and Dekker 5. Design of experiments for process improvement and quality Assurance; R. F. Brewer, Narrosa 6. ISO 14000 & ISO 9000, B. Othary; Gower 7. Understanding ISO 9000 and implementing the basics of Quality; D. H. Stamantis; Macel and Dekker 8. Food Additives- R J Taylor 9. Antimicrobials in food- Alfred Larry Branen 10. The chemical analysis of foods food products- Morris B Jacobs 11. Introduction to chemical analysis of foods S.Suzanne Neilson 12. Applied Microbiology Vilita Kale, Kishore Bhushan 13. Indian Herbal Pharmacopoiea Vol I & II

M22 : QUALITY ASSURANCE TECHNIQUES III (Theory 2 Hrs/week) 1. Rules and regulations Rules governing manufacturing of formulations in India Drugs and cosmetics act and Rules, Narcotic Drugs and Psychotic substances Act and Rules, Magic Remedies and Objectionable Advertisement Act, Consumer Protection Act, Factory Act. 2. Process Validation Differences and similarities between process qualification and process validation, protocols, methodology and interpretation of data, validation like mixing granulation, drying, compression, filing and water process system. 3. Equipment Validation Installation qualification and operational qualification for sterilization equipments like autoclave, oven membrane filter. 4. Cleaning validation Validation requirements and validation of effective cleaning. 5. Vendor validation Vendor audit, sample testing and trend analysis. 6. Validation of services Validation of training, maintenance 7. Validation of electronic data processing Software validation methodology

ML2 ; QUALITY ASSURANCE TECHNIQUES II (Practicals) 1. 2. 3. 4. 5. 6. 7. 8. 9. Validation of processes mixing, drying, compression Validation of equipments like autoclave, oven, membrane filter Validation of cleaning method Experimentation and documentation of dissolution test IPQC teste for tablets/capsule/injection/liquids/ointments Biochemical analysis of Drugs/enzymes. Qualitative analysis of herbal raw material Quallitative analysis of food products/substances. Microbiological assays of Antibiotics/Vitamns.

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.

M31 : DRUG REGULATORY AFFAIRS (Theory 2 Hours / Week) WHO, GMP guidelines ICH stability guidelines UK MOA guidelines Australian TGA guidelines South Africa MCC guidelines GMP for ayurvedic products Schedule Y New Drug Application US FDA, CDER guidelines Intellectual property right (IPR), patent and copyright, Indian patent act and copyright (Indian act) Good clinical practice (GCP) Good laboratory practice (GLP) Good pharmacy practice (GPP) Pollution control act

M32: QUALITY ASSURANCE TECHNIQUES IV (Theory 2 Hours/ Week) 1. Validation of instruments HPLC, UV and IR spectrophotometer, dissolution test apparatus 2. Validation of Analytical methods as per ICH guidelines. Validation parameters, accuracy, precision, ruggedness, statistical design, statistical consideration. 3. Packaging and labeling controls, line clearance, reconciliation of labels, cartons and other packaging material, types of glass, tests for assuring quality of glass, types of plastics, permeation, sorption, leaching, chemical reactions, biological tests, modification of plastics by drugs, types of closures and closure liners, film wrapper, blister packs, bubble packs, shrink handling, foil/plastic pouches, bottles seals, tape seals, breakable seals and sealed tubes, quality control of packaging materials and filling equipment 4. Loan License auditing- concept and auditing 5. C-GMP 6. Guidelines and Techniques for experiments on animals 7. Impurity profile of drugs 8. Hyphenated techniques like LC-MS, GC-MS 9. Supercritical fluid chromatography, High efficiency enantiomers separation RECOMMANDED BOOKS : Good Laboratory Regulations; S. Weinberg; Vol.69; Marcel and Dekker Encyclopedia of Pharmaceutical Technology; J. Swarbrick, Boylon; Marcel and Dekker Pharmaceutical Process Validation; J. R. Berry, R. A. Nash; Marcel and Dekker Good Manufacturing Practices for Pharmaceutics; S. H. Will, J. R. Stocker; Marcel and Dekker Design of experiments for process improvement and Quality Assurance; R. F. Brewer, rosa ISO 14000 & ISO 9000, B. Othary; Gower Understanding ISO 9000 and implementing the basics to Quality; D. H. Stamentis; Marcel and Dekker Quality Assurance of Pharmaceuticals A compendium of guidelines and related materials Vol. I; WHO publications A guide to Total Management; Kaushik Maitra, Sedhan K Ghosh ISO 9000 and TQM Sedhan K Ghosh