MPharm Proposed 28.3.12

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M. Pharm. Syllabus (Draft) updated on 28 March 2012 (5.30 pm)

Structure of M.Pharm (Quality Assurance)

Semester I

Subject Theory/week(hr)

Practical/week (hr)

Total Periodic Testhours

PeriodicMarks

UniversityExamhours

University ExamMarks

CommonPaper I(ModernPharmaceutical Analysis)

4 hr 6 hr 10 hr 1/3(Th/Pr)

20 3/6(Th/Pr)

80

CommonPaper II(ResearchMethodology,Statistics &

ComputerApplications)

4 hr - 4 hr 1 20 3 80

Specialization I(ProductDevelopment)

4 hr 6 hr 10 hr 1/3 20 3/6 80

Specialization II(AdvancedQA

Technology)

4 hr - 4 hr 1 20 3 80

28 hrSemester II


Practical/week (hr)


Periodic Marks

University Examhours


Specialization III(BiologicalEvaluation)

4 hr 6 hr 10 hr 1/3(Th/Pr)

20 3/6(Th/Pr)

80

Common

Paper III(RegulatoryAffairs & IPR)

4 hr - 4 hr 1 20 3 80

Specialization IV(ProductDevelopment& Packaging)

4 hr 6 hr 10 hr 1/3 20 3/6 80


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Specialization V

4 hr - 4 hr 1 20 3 80

28 hr

General Structure of M.Pharm (Sem- I and Sem II)

Semester I


Practical/week (hr)


PeriodicMarks

UniversityExamhours


CommonPaper I(ModernPharmaceutical Analysis)

4 hr 6 hr 10 hr 1/3(Th/Pr)

20 3/6(Th/Pr)

80

CommonPaper II(ResearchMethodology,Statistics &ComputerApplications)

4 hr - 4 hr 1 20 3 80

Specialization I

4 hr 6 hr 10 hr 1/3 20 3/6 80

Specialization II

4 hr - 4 hr 1 20 3 80

28 hr

Semester II

Subject Theory/ week(hr)

Practical/week (hr)


PeriodicMarks

UniversityExamhours


Specialization III

4 hr 6 hr 10hr

1/3(Th/Pr)

20 3/6(Th/Pr)

80

CommonPaper III(Regulatory

Affairs &IPR)

4 hr - 4hr

1 20 3 80

Specialization IV

4 hr 6 hr 10hr

1/3 20 3/6 80

Specialization V

4 hr - 4hr

1 20 3 80

28


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hr

Modern Pharmaceutical Analysis(Common Paper I) 72 hr

No Topics Duration

I

1

2

3

4

Separation Techniques:

Classification of chromatographic methods based on mechanism of

separation & their basic principles including Ion exchange and separationof chiral compounds.

Gas Chromatography: Instrumentation, column efficiency parameters,derivatisation methods, application in pharmaceutical analysis, validation

of analytical method

Liquid Chromatography: Instrumentation in HPLC, UPLC, Comparisonof GC & HPLC, phase packing materials, column selection, mobile phase

selection, efficiency parameters, application in pharmaceutical analysis

including validation of analytical method.

HPTLC: Instrumentation & pharmaceutical applications of HPTLC

Advanced techniques: Flash chromatography, Supercritical Fluid

chromatography, Capillary Electrophoresis (CE)

3

6

8

3

4

II

1

2

3

Spectroscopic Methods:

UV- Visible spectroscopy: Introduction, Basic principles, Applications;

Absorption spectra of organic compounds & complexes illustrating thephenomenon & its utilization in qualitative & quantitative studies of drugs;

calculation of absorption maximum of unsaturated hydrocarbons-

Woodwards-Fieser Rule, Derivative spectroscopy, Derivation of equationfor Simultaneous determination and Absorbance Ratio methods,

Application of Chemometrics.

IR Spectroscopy: Interaction of infrared radiation with organic molecules

& its effect on bonds; Sample handling, detailed interpretation of ir spectra,Pharmacopoeial Importance of ir spectra.

Instrumentation in Brief, Dispersive IR spectrophotometer compared withFTIR and ATR

NMR Spectroscopy: Fundamental principles of NMR, Concept ofChemical shift, Spin-spin coupling, Decoupling techniques and their

importance, shielding & deshielding; solvents in pmr and 13C-NMR;

6

5

1

10


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4

Detailed interpretation studies of pmr spectra; Introduction & application of13C-NMR spectra and 2D NMR.

Instrumentation in Brief, FTNMR.

Mass Spectroscopy: Basic principles Ionization techniques, mass

spectrum & its characteristics - molecular ion, metastable ion, fragment

ions, isotope ions; fragmentation process and rules & characteristicfragmentation patterns, fragment characteristics in relation to parent

structure & functional groups; relative abundance of isotopes & theircontribution to characteristic peaks.

Mass spectroscopy in MetabolomicsInstrumentation- Mass spectrometers, Tandem mass spectrometers

Hyphenated instruments LCMS, GCMS

2

7

3

III

1

2

3

Other Techniques:

Thermal Analysis: Theory, instrumentation & applications of Thermo-

gravimetric analysis,differential thermal analysis, differential scanning

calorimeter.

Immunochemical Techniques: Immuno-electrophoresis, Immuno-precipitation, ELISA, Radioimmunoassay.

Powder X-ray Diffraction: Braggs law and its applications,

Instrumentation and pharmaceutical applications.

6

4

4

References:

1. Skoog, DA, Holler, FJ, Crouch, SR. Principles of instrumental analysis. 6thed., Baba Barkha

Nath printers, Haryana, 20072. Silverstein, RM, Webstar, FX. Spectrometric identification of organic compounds. 6

thed., John Wiley & Sons (Asia) Pvt. Ltd., Singapore, 2005

3. William Kemp. Organic spectroscopy, 3rded., Palgrave, New York, 20064. Jag Mohan, Organic spectroscopy: Principles and Applications, 2nded., Narosa publishinghouse Pvt Ltd., New Delhi, 2005

5. Conners KA. A Text book of pharmaceutical analysis, 3rd ed., John Wiley & Sons, Singapore,

20046. Willard HH, Merritt LL, Dean JA, Settle FA. Instrumental methods of analysis, 7 th ed., CBS

Publishers & Distributors, New Delhi, 1986

7. Pavia DL, Lampman GM, Kriz GS, Vyvyan JA. Introduction to spectroscopy. 4th ed.,Brookescole publishers, California, 2008

8. Sharma BK. Instrumental methods of chemical analysis, 25 th Ed., Goel Publishing house,

Meerut, 2006

9. Beckett, AH, Stenlake, JB. Practical pharmaceutical chemistry, Part I & II, 4th

ed., CBSPublishers & distributors, New Delhi, 2004

10. Ewing, GW. Instrumental methods of chemical analysis, 5thed., McGraw Hill Book

Company, New York, 198511. Schirmer, RE. Modem methods of pharmaceutical analysis, Vol. I & II, 2nded., CRC Press,

Florida, 2000

12. Moffat, AC, Osselton, MC, Widdop, B. Clarke's analysis of drugs and poisons, Vol. I & II,3rd ed., K.M. Varghese Company, Mumbai, 2004


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Modern Pharmaceutical Analysis (Practicals)

*A minimum of 18 Practicals (Exercises on both Quantitaive, Qualitative analysis to be

elaborated) shall be conducted from the following.

Practical-1

UV/Visible spectrum scanning of a few organic compounds for UV- absorption and correlations

of structures and isosbestic point in case of mixtures.

Practical-2 to 3

Effect of solvents and pH on UV spectrum of drugs

Determination of Rate constant by UV spectroscopy

Practical-4 to 8

Estimation of multi component formulation by UV- Spectrophotometer in formulations

(Simultaneous equation Method, Absorbance Ratio Method)Practical-8 to 9

Experiments based on the application of derivative spectroscopy.

Practical-10 to 11

Experiments based on HPLC (Isocratic and Gradient elution) techniques.

- Single and multiple component analysis- Calculation of System Suitability Parameters

Practical-12 to 14

Interpretation of drugs by IR spectra Use pharmacopoeial spectra (atleast 10) for correlation ofstructural features

Practical- 15 to 19

Workshop of spectroscopy: (UV, IR, NMR, Mass) structural elucidation of atleast 10 compoundswith UV, IR, NMR and Mass spectral data.

Practical-20

Separation of protein drug substances by electrophoresis


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Research Methodology, Statistics & Computer Applications (Common Paper II)

No Topics Duration

I

1

2

3

4

5

6

Research Methodology

Introduction: Meaning & Objectives of research, types of research,approaches to research; Research methods, research process; Criteria for

good research, common problems, qualitative & quantitative research

methods.

Research Topic: Selection of research problem, research design;

meaning, concept & features of research design, experimental design,

plan of research work.

Data Collection: Primary & secondary data collection method, designof questionnaires for data collection, identification of sources of

information, searching and classifying information;

compilation, processing & analyzing of data & information.

Interpretation of Results and Presentation: Meaning of

interpretation, techniques of interpretation; scientific writing & report

preparation, fundamentals of scientific writing, report preparation, types& layout of report, precautions in writing research report; statistical

aspects of research output.

Principles of validity & reliability of research work, ethical aspects ofresearch methodology.

Developing research proposals: Format of research proposals,Individual & Institutional research proposals.

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6

10

8

6

6

II

1

2

3

4

Statistics and Computer Applications

Introduction, Concept of Statistics in Quality Control (SQC), its role and

uses. Collection, organization, graphic & pictorial representation of

data, measurement of central tendencies & dispersion; degree offreedom, standard deviation, standard error, Coefficient of variation,

Probability, Sample and Sampling method

Estimation and Hypothesis testing:Null Hypothesis, confidence level,

Point & interval estimation, concept of hypothesis testing & types oferror, Student t test, Chi-Square test.

Linear regression and Correlation: Analysis of variance (one way &

two way), Factorial designBrief review of non parametric tests, experimental design in clinical

trials, statistical test for bioequivalence, Dose-Response study, statistical

quality control; validation, optimization techniques & screening design,significance of coefficient of correlation, non-linear regression,

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Application of software for statistical calculations.Validation and security measures for electronic data and computer

assisted process.

References:

(1) Research in education John W. Best Jems V. Kahn(2) Research methodology C. R. Kothari(3) Methodology and techniques of social research Willkinson and Bhandarkar

(4) Presentation skills Michel Halton Indian society for institute education

(5) Practical introduction to copyrights Gavin Mofariane(6) Thesis projects in sciences and engineering Richard M. Devis

(7) Scientist in legal system 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 Edwards hospital foundation for London

(14)How to write and publish a scientific paper Robert A. Day Cambridge University Press 4th

Edition, 1994(15)Introduction to Statistical Methods- C. B. Gupta

(16)A first course in Mathematical Statistics- C. E. Weatherborn

(17)Introduction to Biostatistics-Mahajan(18)Experimental Pharmacology by S K Kulkarni.

(19)Fundamentals of Science & Technology Communication N R Rajagopal, NISCAIR

(CSIR)


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Drug Regulatory Affairs & Intellectual Property Rights (Common Paper III)

No Topic Duration

I

1

2

3

4

Regulatory Affairs:

Historical perspectives, organization structure, activities and

responsibilities of drug regulatory agencies in India, US, EU, Australia,Africa

Concepts of total quality management, Good laboratory practices and ISO;

Quality assurance & quality control for APIs and other intermediates inprocess & finished products.

GMP for bulkdrugs & formulations,Good clinical practice guidelines.US Regulatory practices,

ICH guidelines.

Validation of process, equipments, procedures, validation master plan.

Documentation like master records, batch records, regulatory compliance

records, distribution records, drug recall registers, management review

records.

Regulatory Acts: Drugs & Cosmetic act-1940 & rules 1945 with special

relevance to schedule M, Y, U; latest drug price control order & latest drugpolicy

Pollution & environmental control act.

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6

4

42

2

4

8

6

4

II

1

2

3

Intellectual Property Rights:

Introduction: Scope, Objectives & IPR in pharmacy, Indian legal system

& its role in IPR; importance for pharma industry.

Concept of property with respect to intellectual creativity; Tangible &Intangible property,

concept of IPR, scope & nature of patents, copyrights, trade mark,geographical limitations.

Patent and its Practical aspects: Indian Patent Act 1970, Patenting in

India & abroad, role of international organization WTO, WIPO, EPO inpatent act; practical aspects of patent filing, components of a patent

application in India, PCT filing, patent infringement & litigation therein,

commercialization & licensing

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6

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4 Ethics in IPR: Positive & negative aspects, drug related controversies,

traditional knowledge, current strategies & solutions. 8

References:1. Drugs & Cosmetics Act 1940 and rules there under.2. Drugs Laws by Hussain.

3. Indian Patent Act.

4. Quality assurance & GLP by Y. Anjaneyulu.5. Quality control & Application by Bentrand L. Hanser.

6. Quality assurance in Analytical chemistry by Werner Funk..

7. Guidelines of various countries like MCA, TGA, ICH.8. GLP regulation by Alen Hirsch Vol 38 Marcel Decker series

9. GMP for pharmaceuticals forth edition by S. Willing, J. Stocker Marcel Decker series 1997.

10. I.P., B.P., U.S.P. International Pharmacopoeia


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Product Development & Formulation (Quality Assurance - Specialization I)

No. Topic Duration

1 Pre-Formulation:

A consideration of physio-chemical characteristics of medicinal agents in

their dosage form.

Physical characteristics:

Particle size, polymorphism, crystal form, solubility, Interfacial tension,

Salt formation, wetting of solids, flow characteristics, compressibility,Rheology, Partition coefficient.

Chemical Characteristics:

Degradation-Hydrolytic, oxidative, reductive, photolytic.

Biopharmaceutical Characteristics:Liquid solubility, dissociation constant, dissolution rate, bulk solubility and

diffusibility in diffusion layer, drug stability in G.I.track, complexation.

10

2 Quality Control- Process & Dosage forms:

Sources of variations, control of variation-material control andmanufacturing control.

Statistical quality control- sampling, testing programme and methods.

8

3 Pilot Plant Scale-up Techniques:

Evaluation of formula, equipments, raw materials, process, stability,

uniformity. Techniques related to tablets including coating, capsules, liquiddosage forms & semi-solid dosage forms.

8

4 Antioxidants, Preservatives, Colorants and flavourants 6

5 Product Development Approach for the following Dosage Forms:

Tablets, Capsules, Sustained release Medication, Injectables Ointments.12

6 Packaging of Pharmaceutical Dosage forms

Types, QC tests8

7 Pharmaceutical Stability Studies- Stability aspects: Basic concept and

objectives of stability study.

Regulatory requirement for stability studies:

A very brief introduction to FDA and WHO guidelines. Detail study of

ICH guidelines [Q1A (R2), Q1B, Q1C, Q1D, Q1E, Q1F, Q5C].Kinetic principles applied for stability evaluation and their applications in

predicting shelf life and half life of pharmaceutical formulations.

Importance of accelerated stability study.

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Degradation pathways (Degradation by hydrolytic, oxidative, reductive,photolytic, etc) and stabilization methods for formulation.

Stability indicating assays and its importance

Stability testing and dating of solid and liquid dosage forms:

Different approaches for stability testing of solid and liquids, kinetic

principles,physical and chemical stability testing of pharmaceutical dosage forms and

packages.

Product life-cycle managementProduct liability and compensation

Stability issues related to proteins and insulin type formulations

Stability issues related to herbal formulations, extracts, fractions andnatural

products/isolated compounds.

Stability issues for vaccines and biological products

10

REFERENCES:

1. Drug Stability, J.T. Carstensen, Marcel Dekker, New York.2. Chemical Stability of Pharmaceuticals-A Handbook for Pharmacists, Kenneth Connors,

John Wiley and Sons, Inc.

3. Good Drug Regulatory Practices: a Regulatory Affairs Quality Manual (Good DrugDevelopment Series) Helene I. Dumit

4. United States Pharmacopoeia-27(NF-22), United State of Pharmacoppeal convention,

INC, 12601 Twinbrook Parkway, Rockville, MD 20852.5. The International Pharmacopoeia Vol. 1,2,3,4, General methods of analysis and quality

specifications for pharmaceutical substances, excipients, dosage forms.6. Phytochemical Methods, J.B.Harborne, Chapman and Hall, London and New York.

7. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in IndianMedicine and Homeopathy).


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Product Development & Formulation (Quality Assurance - Specialization I) Practicals

No. of experiments : Minimum 18 experiments should be covered and relevant documentation to

be carried out in consultation with QA/ QC laboratory of pharmaceutical manufacturingcompany:-

1. Preparation and evaluation of Riboflavin/Ibuprofen tablets I .P. to characterize and evaluate

the effect of different concentrations of binders and disintegrant.2. Optimization of tablet formulation of poorly water-soluble drugs.

3. Design and fabrication of theophylline sustained release formulation and comparison of its

release profile with the conventional dosage form.

4. Formulation and evaluation of micronized disperse system for parenteral delivery of drugsincluding test for pyrogens and sterility testing etc.

5. Preparation of solid dispersions of poorly water soluble drugs using different carriers and to

study the release profile and compare with conventional dosage forms.6. Preparation and evaluation of a hydrodynamically balanced drug delivery system of a drug

having absorption problem

7. Disintegration and dissolution of per oral tablets8. Influence of vehicle on drug availability from topical dosage forms in-vitro

9. Determination of Pharmacokinetic parameters and determination and evaluation of

bioavailability of a drug administered I.V., I.M. and P.O.

10. Design and preparation of a suspension and its evaluation.

11. Development of moisture resistant coating formulation for Amoxycillin tablets/ Ranitidinetablets

12. Quality control of paper, Plastic and glass container13. Quality control of closure

14. Quality control of labels and label adhesives.

15. Microbial limit test in oral products16. Sterility testing of parenteral products

17. Validation of sterilization equipments e.g. Hot air oven, Autoclave.

18. Validation of Analytical procedure

19. Preformulation studies of a model Drug.20. Accelerated stability testing and shelf life determination.

21. Biological evaluation of equipments and materials used in sterile or non-sterile working area.22. Biological evaluation of sterile and non sterile working area.


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iii) Waiver of In Vivo Bioavailability and bioequivalence Studies forimmediate release solid oral dosage forms Based on Biopharmaceutics

Classification system

iv) PAC-ALTS: Post approval changes Analytical TestingLaboratory Site

v) SUPAC IR Immediate release solid oral dosage forms: Scale up

and approval changes: Chemistry Manufacturing and controls In Vitrodissolution testing, and In Vivo bioequivalence documentation

vi) Drug Metabolism / Drug Interaction Process in drug developmentprocess: Studies In Vitro

vii) In Viva Metabolism or drug interaction studies Study design,Data analysis and recommendations for Dosing and Labeling

III A detailed study of Food & Drug Laws affecting drug products design,

manufacture and distribution in USA.

The Federal Food. Drugs & Cosmetics Act 1938. Druham Humphrey Amendment 1951.

Kefauver Harris Amendment 1962.

The Drug Listing Act 1972

Prescription Drug Marketing Act 1987.

6

IV Concept and historical development of pharmaceutical productregistration. Effect of GATT and WTO on commerce of

pharmaceuticals. Introduction to Intellectual Property Rights.

6

V Globalization of drug industries, Export Import Policy of drugs, WHO

certification, Trademarks and copyrights.

6

VI Regulation & licensing of drugs & cosmetics recent amendments andother relevant rules.

Consumer protection ActFactory Act

Loan license

6

VII Standard institutes, certification agencies, Other prominent drugregulatory agencies like ISI, BSS, ASTM, SO, WHO, US-FDA, UK-

MHRA, TGA, MCA

10

VIII Quality control laboratory responsibilities and laboratory practices.

Routine controls on instruments, reagents, sampling plans, standard

test procedures and protocols, control on animal house, data generation

and storage, quality control documentation and audits of QC facilities.

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Biological Evaluation and GLP - (Quality Assurance Specialization III)

Sl. No Topics Duration

1 Biological Evaluation and Standardization Need for biological

models and methodologies

2

2 Laboratory Animalsa) Commonly used laboratory, transgenic and other genetically

prone animal models (viz. nude mice SH rats etc.)

b) Techniques of blood collection, anesthesia & euthanasia of

experiment animals.c) Maintenance & breeding of laboratory animals.

d) Regulation and ethics requirements.e) Guidelines & regulatory agencies CPCSEA, OECD, FDA

ICH, FHSA, EPA, EEC, WHO, etc.

f) Importance of alternative experimental models, its advantages

& disadvantages.

8

3 Principles of Biological Standardizationa) Methods of biological assay, principles of biological assays

with examples as per IP and BP.

b) Development of new bioassay methods.

8

4 Immunoassaya) General principles of immunoassay, Theoretical basis,

Optimization of immunoassay, Heterogenous immunoassay

system, Homogenous immune system.

b) Production of immunoassay reagent: Introduction, receptors orbinders, unlabelled ligands Calibrators, Labelled ligands and

receptor, Separation technique, buffers.

c) Immunoassay Methods Evaluation: Protocol outline, objective& preparation, evaluation of precision, standard tracer,

sensitivity, evaluation of accuracy, antibody characteristics,monitoring, reaction conditions, clinical evaluation.

10

5 Organization of screening for the Pharmacological activity of

new substances with emphasis on evaluation using in-vivo, in-vitro and other possible animal alternative models.

a) General Principles & safety pharmacology procedure.

b) CVS Pharmacology Antihypertensive, Anti arrhythmics,

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Vasodilators, disentail.c) CNS Pharmacology behavioral & muscle co-ordination,

CNS stimulants, antiepileptics, Nootropics.

d) Drugs for Neurodegenerative diseases, like parkinsonism,Alzheimers, multiple sclerosis.

e) Drugs acting on ANS.

f) Respiratory Pharmacology Anti-asthmatics, COPD, Anti-allergic & Mucoactives.

g) Reproductive Pharmacology Aphrodisiacs & antifertilityagents.

h) Analgesics, anti-inflammatory & antipyretics.i) G.I.T. Anti-ulcer, anti-emetics, anti-diarrhoeal & laxatives.

j) Anti-cancer agents.

k) Metabolic disorders like anti-diabetics, anti-hyperlipidemic,anti-obesity, hepatoprotective.

l) Models in drug absorption & metabolism.

m) Immuno Pharmacology specific (cell & hormonalmediated) & non-specific methods.

n) Screening of free radical scavenging activity.

o) Acute, Sub-acute & Chronic toxicity test.

6 Clinical pharmacology and pharmacodynamics: clinical study

design, documentation, presentation and interpretation

8

7 Clinical trials: definition, phase I IV studies, designdocumentation, presentation and interpretation, statistical

analysis of clinical data, factorial design, guidelines as per

Indian and other regulatory authorities.

8

8 Documentation related to New application : NDA and ANDA

requirements, Data presentation pertaining to safety of drug asper FDA requirements

4

9 Good Laboratory Practices (GLP)-

Regulations , biological evaluation, microbiological limit tests,

sterility tests for effectiveness of antimicrobial preservative , LD50, ED 50 teratogenicity , mutagenecity , clinical trials ,

Bioassays, pyrogens and pyrogen testing safely testing

presentation of related data and supporting raw data.

9

10 Related quality systems :

ISO, WHO etc, and their applications in pharmaceutical industry.

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RECOMMENDED BOOKS

1. S. Weinberg, Good laboratory practice Regulations, Marcel and Dekker.

2. J. Swarbrick Boylan, encyclopedia of pharmaceutical technology, Marcel

and Dekker.3. J.R. Berry and R.A. Nash, Pharmaceutical process validation. Marcel and

Dekker.

4. S.H. Will and J.R. Stoker, good manufacturing Practices forPharmaceutics Marcel Dekker.

5. R.F. Brewer, Design of experiments for process improvement and quality

Assurance Narrosa.6. B. Othery. ISO 14000 and ISO 9000 Gower.

7. D.H. Stamatis, Understanding ISO 9000 and implementing the basics to

quality; Marcel Dekker.8. Biological standardization by J.H. Burn, D.J. Finney & L.G. Goodwin.

9. I.P. & B.P.10. Screening Methods in Pharmacology by R.A. Turner. Vol. I & II Academic Press, New

York and London.11. Evaluation of drug activities by Laurence & Bacherce.

12. Methods in Pharmacology by Arnold Schwartz.

13. Selected topics on Experiment Pharmacology by Issha G. Kamat, Dadkar, N.K. & Seth,UK.

14. Fundamental of Experimental Pharmacology, by M..N. Ghosh. Scientific Book Agency,

Calcutta.15. Pharmacological Experiment on intact preparation by Churchill Livingstone

16. Drug Discovery and evaluation by H.G. Vogel & W.H. Vogel. Springer Verlag, Berlin

Heideleberg.17. Animal Model in Toxicology by Shayne Cox Gad & Christopher P, Chengelis.

18. Principles & Methods of Toxicology by Hays.

19. CRC Handbook of Toxicology by Derelako & Hollinger.

20. Handbook of Experimental Pharmacology by S.S. Kulkarni. Vallabh Prakashen, Delhi.21. Pharmacological Experiments on Intact and Isolated preparations, Edinburgh University

Pharmacology Staff, Livingstone.

22. Goodman and Gilmans The Pharmacological basis of Therapeutics Ninth edition,Editors. A. G. Gilman, J. G. Hardman, L. E. Limbiod, P. B. Melineff, R. W. Rudder,

Macmillan Publishing Co. Inc. Latest edition.

23. Clinical Pharmacotherapecutics, edited by Kamalesh Kohli, Elsevier Publication


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Biological Evaluation and GLP - (Quality Assurance Specialization III) -PRACTICALS

(6 HOURS/WEEK)

EXPERIMENTS BASED ON FOLLOWING1. Sterility testing of medical devices. LVP antibiotics, ophthalmic

preparation.

2. Pyrogen testing.3. Microbiological limit test of starch, acacia and antacid preparation.

4. LD 50 and ED 50 determination.

5. Eye irritation and Patch test.6. Bioassays of some drugs.

RECOMMENDED BOOKS

1. S. Weinberg, Good laboratory practice Regulations, Marcel and Dekker.

2. J. Swarbrick Boylan, encyclopedia of pharmaceutical technology, Marceland Dekker.

3. J.R. Berry and R.A. Nash, Pharmaceutical process validation. Marcel and

Dekker.4. S.H. Will and J.R. Stoker, good manufacturing Practices for

Pharmaceutics Marcel Dekker.

5. R.F. Brewer, Design of experiments for process improvement and qualityAssurance Narrosa.

6. B. Othery. ISO 14000 and ISO 9000 Gower.

7. D.H. Stamatis, Understanding ISO 9000 and implementing the basics to

quality; Marcel Dekker.


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Pharmaceutical Method Development

and Validation - (Quality Assurance Specialization IV)

Sl.No.

Topics Duration

1 Introduction to pharmaceutical validation: definition, manufacturing

process model, scope of validation, advantage of validation, organization

for validation, validation of master plan, types of process validation,design qualification, installation qualification, operational qualification

and performance qualification of facilities.

10

2 Process validation: prospective, concurrent, retrospective and

revalidation,Process validation of formulations like tablets, capsules, ointment/creams,

liquid orals, sterile dosage form which should include following aspectsof

Personnel and organizationo Raw materials

o Equipments (e.g. Dry powder mixers, fluid bed and tray dryers, tablet

compression machine, capsule filling machines etc)o Area, premises and environment including storage of raw materials to

finished

productso Water (validation of pharmaceutical water system and pure steam),

o Packaging and labeling controls and its validation

o Cleaning validation: cleaning of equipment, cleaning of facilitieso Validation of Integrated lines by media fill test.o Validation of HVAC system

Vendor Certification.

Validation of compressed air, validation of water and air handling systemsValidation of existing equipment and utilities validation

Computer system validation including installed softwares

Pharmaceutical development of drug substance and drug product,formulations, manufacture and supply of materials, labeling and

presentation, stability and storage, purity, compatibility, disposal.

18

3 Method Development and Validation

Application of process analytical technology (PAT) in quality assuranceQualification validation and calibration of equipment. Analytical and

Bioanalytical method validationCalibration and validation of various instruments used for drug analysis

such as UV Visible Spectrophotometer, IR spectrophotometer,

spectrofluorimeter, HPLC, HPTLC and GC.

12

4 Regulatory requirement in pharmaceutical analysis US-FDA, ICH,

PAC-ALTS: Post approval changes analytical testing laboratory site etc.8


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5 Analysis of drug from biological fluids 6

6 Application of analytical methods to product obtained through geneticengineering, Amino acid sequence analysis, tryptic mapping, ion

exchange amino acid analysis, isoelectric focusing etc.

Application of analytical methods to product obtained from naturalsources (extracts, herbal formulations, isolated compounds, modern

herbal formulations) (Compendial methods for evaluation of crude drug

and herbal formulation)

10

7 Dosage form impurity profile and its validation 8

REFERENCES:

1. Pharmaceutical Process Validation, B. T. Loftus and R. A. Nash, Drugs and Pharm Sci.Series, Vol. 129, Marcel Dekker Inc., New York.

2. Pharmaceutical Packaging Technology, Dean, D. A. Evans, E. R. and Hall, J. H., Taylor and

Francis, London.3. Validation of Aseptic Pharmaceutical Processes, Carleton and Agalloco, Marcel Dekker

Inc., New York.

4. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical andBiotechnology Industries by Syed Imtiaz Haider and Erfan Syed Asif5. Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and

Regulatory Compliance, Second Edition by Guy Wingate

6. Pharmaceutical Process Scale-Up, Michael Levin, Drugs and Pharm. Sci. Series, Vol. 157,Marcel Dekker Inc., New York.

7. Pharmaceutical Packaging Technology, Dean, D. A. Evans, E. R. and Hall, J. H., Taylor and

Francis, London.8. Pharmaceutical Analysis Modern Methods Part A, Part B, J. W. Munson, Marcel

Dekker, NY.

9. Spectroscopic identification of organic compounds. John Dyer, Willy, NY.

10. Organic Spectroscopy W. Kemp, NY.11. NMR spectroscopy (Basic Principles, concepts and application in Chemistry) Herald

Gunther, (John Wiley and Sons), NY.

12. Spectroscopic identification of organic compounds. R.M. Silverstein, G.C. Bassler, T.C.Morrill, Pub: John Wiley and Sons, NY.

13. Quality control of herbal drugs: an approach to evaluation of botanicals, Pulok K.

Mukherjee, 2002, Business horizons.14. Encyclopedia of Pharmaceutical Technology Vol.1-3, Swarbric, J and Bolyln, J. C., Marcel

Dekker, Inc., New York.

15. United States Pharmacopoeia-27(NF-22), 2004, United State of Pharmacoppealconvention, INC, 12601 Twinbrook Parkway, Rockville, MD 20852.

16. The International Pharmacopoeia Vol. 1,2,3,4, General methods of analysis and qualityspecifications for pharmaceutical substances, excipients, dosage forms.

17. Phytochemical Methods, J.B.Harborne, Chapman and Hall, London and New York.18. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian

Medicine and Homeopathy)


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Pharmaceutical Method Development

and Validation - (Quality Assurance Specialization IV) - Practicals

*A minimum of 18 Practicals shall be conducted.

Practical 1: Prerequisite (01)Basics of instrumentation, validation documentation

Practical 2: (06)

1) Quantitative estimation by UV, HPLC2) Acquaintance with working or principles of major spectroscopic and chromatographic

techniques (IR, NMR, MS, AAS, GC, HPTLC and HPLC etc

Practical 3: (02)

1. Method development and validation using UV, HPLC and HPTLC

Practical 4: (03)

1. Quantization of different phytoconstituents from extracts and herbal formulation bySpectroscopic, HPLC and HPTLC method

Practical 5: (02)1. Stability indicating assay methods

Practical 6: (02)

1. Impurity profile (AIP, formulations)

2. Quantitative estimation of drugs in biological fluids

Practical 7: (04)

1. Validation of following equipment:

Autoclave, hot air oven, powder mixer (dry), tablet compression machine and

equipments required for formulations2. Validation of a processing area.

3. Cleaning validation of equipment.

4. Validation of tablet, capsule, liquid (oral, topical etc) manufacturing facilities5. Evaluation equipments validation

Practical 8: (01)

1. Preparation of calibration master plan

Practical 9: (02)

1. Evaluation and validation of packaging materials & facilities.

2. Test of packaging materials, cartons, aluminum foils, strip packing, blister packing,

ampoules, vials, etc.23

Practical 10: (01)

1. Software, computer system validation.

Practical 11: (01)Documentation involved in above process

REFERENCES:

1. Practical Pharmaceutical Chemistry (part II) by Beckett and Stenlake

2. Interpretation of Mass Spectra of organic compounds-B. Kienicz, C. Djerassi

3. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and4. Biotechnology Industries by Syed Imtiaz Haider and Erfan Syed Asif


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5. Pharmaceutical Process Validation Robert A. Nash, Alfred H. Wachter.

6. Pharmaceutical Analysis Modern Methods Part A, Part B, J. W. Munson, Marcel Dekker,NY.

7. United States Pharmacopoeia-27(NF-22), 2004, United State of Pharmacopeial convention,

INC, 12601 Twinbrook Parkway, Rockville, MD 20852.8. British Pharmacopoeia, 2004, The British Pharmacopoeia commission office, Market Tower,

Nine Elms Lane, London.

9. Indian Pharmacopoeia-2007, Indian pharmacopoeia commission, Sector-23, Raj Nagar,

Ghaziabad.10. Chromatographic Analysis of Pharmaceuticals, A. John, Adamovics, Cytogan Corporation,

Princeton, NJ.

11. Clinical Pharmacotherapecutics, edited by Kamalesh Kohli, Elsevier Publication.12. Biological standardization by J.H. Burn, D.J. Finney and L.G. Goodwin.

13. Pharmaceutics of Solids and Solid dosage form by Cartensens.

14. Advance in Pharm. Sciences by Bean and Beckett.15. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related

Materials (v. 1) by WHO.

16. Good Drug Regulatory Practices: a Regulatory Affairs Quality Manual (Good DrugDevelopment Series) Helene I. Dumitriu.

17. Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management andRegulatory Compliance, Second Edition by Guy Wingate.

18. Relevant articles from journals.19. Quality control of herbal drugs: an approach to evaluation of botanicals, Pulok K.

Mukherjee, 2002, Business horizons.

20. Pharmaceutical Packaging Technology, Dean, D. A. Evans, E. R. and Hall, j. H., Taylor andFrancis, London.

21. Packaging of Pharmaceutical and Healthcare products, H. Lockhart, F. A. Paine, Champman

and Hall, London.22. Packaging of Pharmaceuticals, C.F. Ross.

23. Drug Stability, J.T. Carstensen, Marcel Dekker, New York.

24. Chemical Stability of Pharmaceuticals-A Handbook for Pharmacists, Kenneth Connors, JohnWiley and Sons, Inc.


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Pharmaceutical Quality Assurance and Management (Quality Assurance Specialization V)

Sl. No. Topics DurationStudy of following concepts with relateddocumentation

1 PERSONNEL Introduction,Qualification Experience andTraining, Responsibilities and Key Personnel, Personalhygiene and clothing, Legal Aspects and Consultants

6

2 SURROUNDING, BUILDING AND FACILITIES - Introduction,Principal Area, Plumbing and Drainage system, Lighting,Sewage, Refuge and Disposal of Water, Washing andToilet Facilities, Sanitation, Maintenance

6

3 EQUIPMENT Introduction, Design, size, location andConstruction of Equipment, Equipment Identification,

Equipment log, Cleaning and Maintenance of Equipment,Automatic, Mechanical and Electronic Equipment

8

4 MATERIALS MANAGEMENT Introduction, Purchasing, RawMaterials, Packaging Materials, Intermediate and BulkProducts, Finished Products, Rejected and RecoveredMaterials, Recalled Products, Returned goods, Reagentsand Culture Media, Waste Materials, Reference standardsand Miscellaneous Materials

8

5 QUALITY MANAGEMENT Introduction, Quality Assurance,Components of Q.A., Good Manufacturing Practice,Quality Control

6

6 MANUFACTURING OPERATIONS AND CONTROL Introduction,Sanitation of Manufacturing Premises, Mix-ups and CrossContamination, Processing of Intermediates and Bulkproduct, Packaging Operations, I.P.Q.C., Release ofFinished Product, Process Deviations, Charge-in ofComponents, Time Limitations on Production, Drugproduct Inspection, Expiration Dating, Calculation ofYields, Production Record Review

10

7 DOCUMENTATION AND RECORDS Introduction,Specifications, Master Production and Control Record,Batch Production and Control Record, Important SOPs andRecord, Change Control and Site Master File

8

8 OUTSOURCING Introduction, Manufacturing andPackaging Outsourcing, Analytical Outsourcing, OtherServices- Outsourcing

2


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MPharm Proposed 28.3.12

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