M. PHARM. (QUALITY ASSURANCE)
COURSE STRUCTURE AND SYLLABUS
I YEAR I SEMESTER
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Code
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Group
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Subject
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L
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P
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Credits
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Modern Pharmaceutical Analytical
Techniques
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3
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0
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3
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|
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Advanced Biostatistics and Research
Methods
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3
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0
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3
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Formulation Development and Quality
Control
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3
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0
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3
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Good Manufacturing Practices and Audits
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3
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0
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3
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Evaluation of Pharmaceutical Dosage Forms
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3
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0
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3
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Lab
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Modern
Pharmaceutical Analytical Techniques Lab
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0
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3
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2
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Lab
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Formulation Development and Quality
Control Lab
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0
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3
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2
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Seminar
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-
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-
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2
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Total Credits
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21
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MODERN
PHARMACEUTICAL ANALYTICAL TECHNIQUES
(Common
to All Branches)
Unit I
a. Column
Chromatography: Adsorption and partition, theory, preparation, procedure and
methods of detection
b. Thin Layer
Chromatography: Theory, preparation, procedures, detection of compounds
c. Paper
Chromatography: theory, different techniques employed, filter papers used,
qualitative and quantitative detection
- Counter – current extraction, solid phase extraction techniques, gel filtration
Unit II
a. Gas
chromatography: Introduction, fundamentals, instrumentation, columns:
preparation and operation, detection, derivatisation.
b. HPLC: Principles and
instrumentation, solvents and columns used, detection and applications
Unit III
a.
UV-Visible spectroscopy:
Introduction, electromagnetic spectrum, absorbance laws and limitations,
instrumentation-design and working principle, chromophore concept, auxochromes,
Wood-Fisher rules for calculating absorption maximum, applications of
UV-Visible spectroscopy
b.
IR spectroscopy: Basic
principles-Molecular vibrations, vibrational frequency, factors influencing
vibrational frequencies, sampling techniques, instrumentation, interpretation
of spectra, FT-IR, theory and applications
Unit IV
Mass spectroscopy: Theory, ionization techniques: electron impact
ionization, chemical ionization,
field ionization, fast atom bombardment, plasma desorption, fragmentation
process: types of fission, resolution, GC/MS, interpretation of spectra and
applications for identification and structure determination
Unit V
NMR: Theory, instrumentation,
chemical shift, shielding and deshielding effects, splitting of
signals, spin-spin coupling, proton exchange reactions, coupling
constant(J), nuclear overhauser effect(NOE), 13C NMR
spectra and its applications, 2D-NMR, COSY and applications in pharmacy
REFERENCES
1.Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. A Text book of Pharmaceutical Analysis by Kerrenth A. Connors
4.Vogel’s Text book of Quantitative
Chemical Analysis by A.I. Vogel
5.Practical Pharmaceutical Chemistry by A.H. Beckett and J.B.
Stenlake
6.Organic Chemistry by I. L. Finar
7.Organic spectroscopy by William Kemp
8.Quantitative Analysis of Drugs by D. C. Garrett
9.Quantitative Analysis of Drugs in Pharmaceutical Formulations by
P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by
Silverstein
11. HPTLC by P.D. Seth
12. Indian Pharmacopoeia 2007
ADVANCED
BIOSTATISTICS & RESEARCH METHODS
Unit-I :
Developing a research question, Resources
for research question,
Literature Review: Traditional Qualitative
Review
Meta-Analysis—A
Quantitative Review
Preparation of Research Proposal
Variables—Definition of Variable, Types of
variables—Dependent and Independent variables, Confounded variables,
Measurement of variables, Types of measurement scales and their comparison.
Reliability and Validity of Measurements.
Unit-II :
Validity, Types of validity—Internal
validity, Construct validity, External validity, Threats to validity.
Control: Subject as own control (Within
Subject control), Statistical control.
Unit-III:
Non-experimental Research:
Part 1—Observational, Archival and
Case-Study Research: The Hermeneutic Approach.
Observational Research: Naturalistic
Observation, Participant-Observer Research.
Archival Research: Archival Data Collection
and Compilation.
Case Studies: Characteristic of Case Studies.
Non-experimental Research: Survey
Research—Designing of Questionnaire, Methods of Administration, Response
Rates. Types of Samples—Haphazard
Samples, Purposive Samples, Convenience Samples and Probability Samples.
Unit-IV :
True Experiments: Single-Factor Designs,
Factors, Levels, Conditions, and Treatments.
Within-Subject Designs.
True Experiments Part-2—Factorial
Designs—Main Effects, Interactions, A Mixed Factorial Design.
Unit V :
Single-Subject Experiments: Advantages and
Disadvantages.
Quasi Experiments: The differences between
Quasi and True Experiments.
Design without Control Groups—Interrupted
Time Series Designs and Repeated Treatment Designs.
Prescribed Text Donald H. McBurney
Theresa L. White “Research Methods” ( Cengage learning India
Pvt. Ltd)
FORMULATION
DEVELOPMENT AND QUALITY CONTROL
Unit I
Manufacturing and Quality control of solid dosage forms: Tablets and
Capsules. Liquid Dosage forms: oral and topical
Unit II
Parenterals: Formulation development and evaluation, Aerosol
formulation Development and its quality control.
Unit III
Selection and evaluation of packaging material, containers and
closures, special problems of containers and closures, special problems
interactions. Pharmacoepial specifications, tests and standards for packaging
material
Unit IV
Sterility testing of pharmaceutical products: -Physico chemical
factors affecting stability of drugs, methods to find out degradation path
ways.
Unit V
- Determination of shelf life by Accelerated stability testing
- Incompatibilities encountered in drug multi component formulation, rationale for drug combination case studies.
TEXT BOOKS
1.
Gennaro A.R.Remington the
science and practice of pharmacy.20th edition, volume
1&2, Lippincott Williams and Willkins Pheledelphia , PA
2.
Lachman and Libermann, the
theory and practice of industrial pharmacy, third Edition, Vergis publishing
House, Mumbai 1991.
3.
Banker GS and Rhodes CT New York
4.
Aulten ME.pharmaceutics-The
science of dosage form design, 1st (international student) Edn.
Churchill Livingstone,
New York., 1996
REFERENCES
1.
Lachman L, et al,
pharmaceutical dosage forms, tablets, second edition, volume 1,2, and 3, Marcel
Dekkar, New York
2.
Lachman L. E t a I
Phamraceutical dosage forms parenteral medication second edition Volume 1 and 2
Marcel Décor New York
3.
Turco Sand King RE, sterile
dosage forms, third edition Lea and Febiger, Philadelphia1987.
GOOD MANUFACTURING PRACTICES AND AUDITS
Unit I
GMP general considerations and definitions, Aims & Objectives of
GMPs, GMP requirements for activities of manufacturing/ packaging/ labeling,
testing
Unit II
Introduction to GMPs-MHRA, GMPs-HPFBI, GMPs-MCC,
GMPs-EDQM, etc.
ICH Q7A, GMPs for APIs
Unit
III
Audits: GMP compliance audit, Definition Summary, Audit policy, Internal
and External Audits, Second Party Audits, External third party audits
Unit IV
Preparation for Audit, Conducting audit, audit analysis, audit
report, audit follow up,
Unit V
A typical internal Audit Report (First party), External (Second
party) Audit Report Third party audit report
TEXT BOOKS :
1. How to
practice GMP, 1st Edition, P.P. Sharma
2. Good
Laboratory Practices, Selier, Jurg P
3. Good Pahrm.
Manufacturing Practice Rational and Compliance, John Sharp
SUGGESTED REFERENCES:
1. The Gazette
of India , Extra ordinary, New Delhi
2. A Text book
of Forensic Pharmacy by Mithal
3. WHO Technical
Report Seies, No..908,2003
4. Quality Assurance of Pharmaceuticals
EVALUATION OF PHARMACEUTICAL DOSAGE FORMS
Unit
I
Detailed study
of the principles and procedures involved in various physicochemical methods of
analysis of Pharmaceutical dosage forms belong to the following classes of
drugs.
A. Sulphonamides B. Antibiotics C. Anti- histamines D. Vitamins
Unit
II
A detailed study
on the principles and procedures involved in the determination of the dosage
forms of the following group of drugs
A.
Adrenergics B. Anti- malarials C. Steroids D. Analgesics and antipyretics
Unit
III
Official methods of determination for the
mentioned below pharmaceutical dosage forms of the following group of drugs
A. Local
anesthetics B. Barbiturates C. Anti-diabetics D. Diuretics
Unit
IV
Various in process Quality Control tests
carried on the following of Dosage Forms
A. Tablets B. Capsules C. Injectables D. Liquid Orals
Unit
V
A detailed study on the biological
evaluation of the following dosage forms
A. Rabbis Vaccine B.
Oxytocin C. Tetanus Antitoxin
Unit VI
Microbiological evaluation of the following
dosage forms
A. Neomycin
Sulphate B. Cyanocobalamin C. Diphtheria Vaccine
Recommended
Books:
a.
Remington’s Pharmaceutical
Sciences by Alfonso and Gennaro
b.
Microbiological Assays by
Barton J. Wright
c.
Pharmaceutical Chemistry by
Becket and Stanlake
d.
Quantitative Analysis of Drugs
in Pharmaceutical Formulations by P.D.Sethi
e.
Pharmaceutical Analysis by
Higuchi, Bechmman and Hassan
f.
Theory and Practice of
Industrial Pharmacy by Lieberman and Lachman
g.
Indian Pharmacopoeia 1996
MODERN
PHARMACEUTICAL ANALYTICAL TECHNIQUES LAB
(Common
to All Branches)
1. Use of spectrophotometer for analysis of Pharmacopoeial compounds
and their formulations
2.Simultaneous determination of combination formulations (Minimum of
04 experiments)
3. Effect of pH and solvent on UV spectrum of certain drugs
4. Experiments of Chromatography
a. Thin layer
chromatography
b. Paper chromatography: Ascending, Descending, circular
and two-dimensional techniques
5. Experiments based on HPLC and GC
6. IR, NMR and mass spectra:
Interpretation for the structural elucidation of organic compounds
7. Any other relevant experiments
FORMULATION
DEVELOPMENT AND QUALITY CONTROL LAB
- In process quality control Tests for Tablets, Capsules, Liquid Dosage Forms
- Formulation development and Evaluation of parenterals
- Intraday and interday analysis for the dosage forms
- Determination of shelf life by accelerated stability studies
- Experiments on incompatibility
