SYLLABUS

REGULATIONS 2017
For Courses affiliated to the

KERALA UNIVERSITY OF HEALTH

SCIENCES
Thrissur 680596

BACHELOR OF PHARMACY

Course Code: 009

BACHELOR OF PHARMACY (B. Pharm)

(2017-18 Academic year onwards)

2017
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 Semester-VI
BP601T. MEDICINAL CHEMISTRY III (Theory) 45 Hours
Scope: This subject is designed to impart fundamental knowledge on the structure, chemistry and
therapeutic value of drugs. The subject emphasis on modern techniques of rational drug design like
quantitative structure activity relationship (QSAR), Prodrug concept, combinatorial chemistry and
Computer aided drug design (CADD). The subject also emphasizes on the chemistry, mechanism of
action, metabolism, adverse effects, Structure Activity Relationships (SAR), therapeutic uses and
synthesis of important drugs.
Objectives: Upon completion of the course student shall be able to
1. Understand the importance of drug design and different techniques of drug design.
2. Understand the chemistry of drugs with respect to their biological activity.
3. Know the metabolism, adverse effects and therapeutic value of drugs.
4. Know the importance of SAR of drugs.
Course Content:
Study of the development of the following classes of drugs, Classification, mechanism of action, uses of
drugs mentioned in the course, Structure activity relationship of selective class of drugs as specified in the
course and synthesis of drugs superscripted by (*)
UNIT I 10 Hours
Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical
degradation, classification and important products of the following classes.
β-Lactam antibiotics: Penicillin, Cepholosporins, - Lactamase inhibitors, Monobactams
Aminoglycosides: Streptomycin, Neomycin, Kanamycin
Tetracyclines: Tetracycline, Oxytetracycline, Chlortetracycline, Minocycline, Doxycycline

UNIT II 10 Hours
Antibiotics
Historical background, Nomenclature, Stereochemistry, Structure activity relationship, Chemical
degradation, classification and important products of the following classes.
Macrolide: Erythromycin, Clarithromycin, Azithromycin.
Miscellaneous: Chloramphenicol*, Clindamycin.
Prodrugs: Basic concepts and application of prodrugs design.
Antimalarials: Etiology of malaria.
Quinolines: SAR, Quinine sulphate, Chloroquine*, Amodiaquine, Primaquine phosphate, Pamaquine*,
Quinacrine hydrochloride, Mefloquine.
Biguanides and dihydro triazines: Cycloguanil pamoate, Proguanil.
Miscellaneous: Pyrimethamine, Artesunate, Artemether, Atovaquone.

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UNIT – III 10 Hours
Anti-tubercular Agents
Synthetic anti tubercular agents: Isoniazid*, Ethionamide, Ethambutol, Pyrazinamide, Para amino
salicylic acid.*
Anti tubercular antibiotics: Rifampicin, Rifabutin, Cycloserine, Streptomycin, Capreomycin sulphate.
Urinary tract anti-infective agents
Quinolones: SAR of quinolones, Nalidixic Acid, Norfloxacin, Enoxacin, Ciprofloxacin*, Ofloxacin,
Lomefloxacin, Sparfloxacin, Gatifloxacin, Moxifloxacin
Miscellaneous: Furazolidone, Nitrofurantoin*, Methenamine.
Antiviral agents:
Amantadine hydrochloride, Rimantadine hydrochloride, Idoxuridine trifluoride, Acyclovir*, Ganciclovir,
Zidovudine, Didanosine, Zalcitabine, Lamivudine, Loviride, Delavirdine, Ribavirin, Saquinavir,
Indinavir, Ritonavir.
UNIT – IV 08 Hours
Antifungal agents:
Antifungal antibiotics: Amphotericin-B, Nystatin, Natamycin, Griseofulvin.
Synthetic Antifungal agents: Clotrimazole, Econazole, Butoconazole, Oxiconazole, Tioconozole,
Miconazole*, Ketoconazole, Terconazole, Itraconazole, Fluconazole, Naftifine hydrochloride,
Tolnaftate*.
Anti-protozoal Agents: Metronidazole*, Tinidazole, Ornidazole, Diloxanide, Iodoquinol, Pentamidine
Isethionate, Atovaquone, Eflornithine.
Anthelmintics: Diethylcarbamazine citrate*, Thiabendazole, Mebendazole*, Albendazole, Niclosamide,
Oxamniquine, Praziquantel, Ivermectin.
Sulphonamides and Sulfones
Historical development, chemistry, classification and SAR of Sulfonamides:
Sulphamethizole, Sulfisoxazole, Sulphamethazine, Sulfacetamide*, Sulphapyridine, Sulfamethoxazole*,
Sulphadiazine, Mefenide acetate, Sulfasalazine.
Folate reductase inhibitors: Trimethoprim*, Cotrimoxazole.
Sulfones: Dapsone*.
UNIT – V 07 Hours
Introduction to Drug Design
Various approaches used in drug design. Physicochemical parameters used in quantitative structure
activity relationship (QSAR) such as partition coefficient, Hammett‘s electronic parameter, Tafts steric
parameter and Hansch analysis. Pharmacophore modeling and docking techniques.
Combinatorial Chemistry: Concept and applications of combinatorial chemistry: solid phase and
solution phase synthesis.

BP607P. MEDICINAL CHEMISTRY- III (Practical) 4 Hours / week

I. Preparation of drugs and intermediates
1. Sulphanilamide
2. 7-hydroxy, 4-methyl coumarin
3. Chlorobutanol
4. Triphenyl imidazole
5. Tolbutamide
6. Hexamine

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II . Assay of drugs
1. Isonicotinic acid hydrazide
2. Chloroquine
3. Metronidazole
4. Dapsone
5. Chlorpheniramine maleate
6. Benzyl penicillin
III Preparation of medicinally important compounds or intermediates by Microwave irradiation technique
IV Drawing structures and reactions using chem draw®
V Determination of physicochemical properties such as logP, clogP, MR, Molecular weight, Hydrogen
bond donors and acceptors for class of drugs course content using drug design software Drug likeliness
screening (Lipinski‘s RO5)

Recommended Books (Latest Editions)

1. Wilson and Gisvold‘s Organic medicinal and Pharmaceutical Chemistry.
2. Foye‘s Principles of Medicinal Chemistry.
3. Burger‘s Medicinal Chemistry, Vol I to IV.
4. Introduction to principles of drug design- Smith and Williams.
5. Remington‘s Pharmaceutical Sciences.
6. Martindale‘s extra pharmacopoeia.
7. Organic Chemistry by I.L. Finar, Vol. II.
8. The Organic Chemistry of Drug Synthesis by Lednicer, Vol. 1-5.
9. Indian Pharmacopoeia.
10. Text book of practical organic chemistry- A.I.Vogel.

BP602 T. PHARMACOLOGY-III (Theory) 45 Hours

Scope: This subject is intended to impart the fundamental knowledge on various aspects (classification,
mechanism of action, therapeutic effects, clinical uses, side effects and contraindications) of drugs acting
on respiratory and gastrointestinal system, infectious diseases, immuno-pharmacology and in
addition,emphasis on the principles of toxicology and chronopharmacology.

Objectives: Upon completion of this course the student should be able to:

1. understand the mechanism of drug action and its relevance in the treatment of different infectious
diseases
2. comprehend the principles of toxicology and treatment of various poisoningsand
3. appreciate correlation of pharmacology with related medical sciences.
Course Content:
UNIT-I 10hours
1. Pharmacology of drugs acting on Respiratory system
a. Anti -asthmatic drugs
b. Drugs used in the management of COPD
c. Expectorants and antitussives
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d. Nasal decongestants
e. Respiratory stimulants

2. Pharmacology of drugs acting on the Gastrointestinal Tract

a. Antiulcer agents.
b. Drugs for constipation and diarrhea
c. Appetite stimulants and suppressants.
d. Digestants and carminatives.
e. Emetics and anti-emetics.
f. Drugs on skin - melanising and demelanising agents, drugs used in psoriasis, acne

UNIT-II 10hours
3. Chemotherapy
a. General principles of chemotherapy. including classification of chemotherapeutic agents, microbial
resistance, chemoprophylaxis
b. Sulfonamides and cotrimoxazole. Urinary antiseptics
c. Antibiotics- Penicillins, cephalosporins, monobactam, carbapenem chloramphenicol, macrolides
Lincosamides, quinolones and fluoroquinolones, tetracycline and aminoglycosides, oxazolidinediones

UNIT-III 10 hours
3. Chemotherapy
a. Antitubercular agents
b. Antileprotic agents
c. Antifungal agents
d. Antiviral drugs including anti HIV drugs
e. Anthelmintics
f. Antimalarial drugs
g. Antiamoebic agents
UNIT-IV 08 hours
3. Chemotherapy
Drugs used in UTI and STDs.
Anticancer agents
4. Immunopharmacology
Immunostimulants, Immunosuppressant
Protein drugs, monoclonal antibodies, target drugs to antigen, biosimilars

UNIT-V 07 hours
Gene therapy- concepts, approaches, gene transfer techniques and application Stem cell therapy -an
overview

BP 608 P. PHARMACOLOGY-III (Practical) 4Hrs/Week

1. Anti allergic activity by mast cell stabilization assay
2. Study of anti-ulcer activity of a drug using pylorus ligand (SHAY) rat model and NSAIDS induced
ulcer model.
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3. Estimation of serum biochemical parameters .
4. Effects of skeletal muscle relaxants using rota-rod apparatus.
5. Effect of drugs on locomotor activity using actophotometer.
6. Anticonvulsant effect of drugs by MES and PTZ method.
7. Study of stereotype and anti-catatonic activity of drugs on rats/mice.
8. Study of anxiolytic activity of drugs using rats/mice.
9. Anti-inflammatory activity of drugs using carrageenan induced paw-edema model.
10. Analgesic activity of drug using central and peripheral methods
11. Biostatistics methods in experimental pharmacology ( student s t test, ANOVA)
12. Biostatistics methods in experimental pharmacology (Chi square test, Wilcoxon Signed Rank test)
Note: Wherever wet laboratory experiments are not feasible, simulated experiments bysoftware
/videos may be used.

Recommended Books (Latest Editions)

1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale s Pharmacology, Churchil
Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc Graw-Hill
3. Goodman and Gilmans, The Pharmacological Basis of Therapeutics
4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K., Bradley
R.W., Applied Therapeutics, The Clinical use of Drugs. The Point Lippincott Williams & Wilkins
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincotts Illustrated Reviews- Pharmacology
6. K.D.Tripathi. Essentials of Medical Pharmacology, , JAYPEE Brothers Medical Publishers (P) Ltd,
New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher Modern
Pharmacology with clinical Applications, by Charles R.Craig& Robert,
8. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata,
9. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,
10. N.Udupa and P.D. Gupta, Concepts in Chronopharmacology.

BP 603 T. HERBAL DRUG TECHNOLOGY (Theory) 45 hours

Scope: This subject gives the student the knowledge of basic understanding of herbal drug industry, the
quality of raw material, guidelines for quality of herbal drugs, herbal cosmetics, natural sweeteners,
nutraceuticals etc. The subject also emphasizes on Good Manufacturing Practices (GMP), patenting and
regulatory issues of herbal drugs
Objectives: Upon completion of this course the student should be able to:
1. understand raw material as source of herbal drugs from cultivation to herbal drug product
2. know the WHO and ICH guidelines for evaluation of herbal drugs
3. know the herbal cosmetics, natural sweeteners, nutraceuticals
4. appreciate patenting of herbal drugs, GMP .
5. To understand the preparation and development of herbal formulation
6. To understand the herbal drug interactions.

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Course content:
UNIT-I 06 Hours
Herbs as raw materials
Definition of herb, herbal medicine, herbal medicinal product, herbal drug preparation. Selection,
identification and authentication of herbal materials. Processing of herbal raw material
Biodynamic Agriculture
Good agricultural practices in cultivation of medicinal plants including Organic farming. Pest and Pest
management in medicinal plants: Biopesticides/Bioinsecticides.
UNIT-II 05 Hours
a) Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy
b) Preparation and standardization of Ayurvedic formulations viz; Aristas and Asawas, Ghutika,Churna,
Lehya and Bhasma.

UNIT-III 07 Hours
Nutraceuticals
General aspects, market, growth, scope and types of products available in the market. Health benefits and
role of Nutraceuticals in ailments like Diabetes, CVS diseases, Cancer, Irritable bowel syndrome and
various Gastro intestinal diseases.
Study of following herbs as health food: Alfalfa, Chicory, Ginger, Fenugreek, Garlic, Honey, Amla,
Ginseng, Ashwagandha, Spirulina
Herbal-Drug and Herb-Food Interactions: General introduction to interaction and classification. Study
of following drugs and their possible side effects and interactions: Hypericum, Kava-kava, Ginkobiloba,
Ginseng, Garlic, Pepper & Ephedra.
UNIT-IV 10 Hours
Herbal Cosmetics
Sources and description of raw materials of herbal origin used in herbal cosmetics such as
a) Fixed oils: Almond oil ,Arachis oil, castor oil ,olive oil, coconut oil
b) Waxes: Bees wax, Carnauba wax, Paraffin wax, Spermaceti
c) Gums: Guar gum, Sodium Alginate, Tragacanth
d) Colours: Cochineal, Saffron, Indigo, Henna
e) Perfumes: Rose oil, Jasmine oil, Lavender oil.
f) Protective agents: Neem, Cucumber, Aloe
g) Bleaching agents: Lemon, Turmeric
h) Antioxidants: Green tea, Sesame oil in products such as skin care, hair care and oral hygiene products.
Herbal excipients:
Significance of substances of natural origin as excipients colorants, sweeteners, binders, diluents,
viscosity builders, disintegrants, flavors & perfumes.
Herbal formulations:
Conventional herbal formulations like syrups, mixtures and tablets and Novel dosage forms like
phytosomes

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UNIT- V 10 Hours
Evaluation of Drugs: WHO & ICH guidelines for the assessment of herbal drugs, stability testing of
herbal drugs.
Patenting and Regulatory requirements of natural products:
a) Definition of the terms: Patent, IPR, Farmers right, Breeders right, Bioprospecting and Biopiracy.
b) Patenting aspects of Traditional Knowledge and Natural Products. Case study of Curcuma & Neem.
Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC), Regulation of manufacture of ASU
drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs.

UNIT-VI 07 Hours
General Introduction to Herbal Industry
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on medicinal and aromatic
plants in India.
Schedule T - Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule- T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipments, standard operating
procedures, health and hygiene, documentation and records.

BP 609 P. HERBAL DRUG TECHNOLOGY (Practical) 4 hours/ week

1. To perform preliminary phytochemical screening of crude drugs.
2. Determination of Ash values
3. Determination of moisture content of crude drugs
4. Determination of Extractive values of crude drugs
5. Determination of the alcohol content of Asava and Arista
6. Preparation of herbal cosmetics
7. Preparation and standardization of herbal formulation
8. Determination of swelling index and foaming index
9. Monograph analysis of herbal drugs from recent Pharmacopoeias
10. Analysis of fixed oils

Recommended Books: (Latest Editions)

1. Textbook of Pharmacognosy by Trease & Evans.
2. Textbook of Pharmacognosy by Tyler, Brady & Robber.
3. Pharmacognosy by Kokate, Purohit and Gokhale
4. Essential of Pharmacognosy by Dr.S.H.Ansari
5. Pharmacognosy & Phytochemistry by V.D.Rangari
6. Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian Medicine &
Homeopathy)
7. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals.
Business Horizons Publishers, New Delhi, India, 2002.

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BP 604 T. BIOPHARMACEUTICS AND PHARMACOKINETICS (Theory) 45 Hours
Scope: This subject is designed to impart knowledge and skills necessary for dose calculations, dose

Adjustments and to apply Biopharmaceutics theories in practical problem solving. Basic theoretical
discussions of the principles of Biopharmaceutics and pharmacokinetics are provided to help the students
to clarify the concepts.
Objectives: Upon completion of the course student shall be able to
1. Understand the basic concepts in biopharmaceutics and pharmacokinetics.
2. Use plasma data and derive the pharmacokinetic parameters to describe the process of drug
absorption, distribution, metabolism and elimination.
3. Critically evaluate biopharmaceutic studies involving drug product equivalency
4. Design and evaluate dosage regimens of the drugs using pharmacokinetic and biopharmaceutic
parameters.
5. Detect potential clinical pharmacokinetic problems and apply basic pharmacokinetic principles to
solve them
Course Content:
UNIT-I 10 Hours
Introduction to Biopharmaceutics
Absorption; Mechanisms of drug absorption through GIT, factors influencing drug absorption though
GIT, absorption of drug from Non per oral extra-vascular routes, Distribution of drugs Tissue
permeability of drugs, binding of drugs, apparent, volume of drug distribution, protein binding of drugs,
factors affecting protein-drug binding. Kinetics of protein binding, Clinical significance of protein
binding of drugs

UNIT- II 10 Hours
Biotransformation Phase I and Phase II reactions.
Drug Elimination: Renal excretion of drugs, factors affecting renal excretion of drugs, renal clearance,
Non renal routes of drug excretion of drugs
Bioavailability and Bioequivalence: Objectives of bioavailability studies, absolute and relative
bioavailability, measurement of bioavailability, in-vitro drug dissolution models, in- vitro, in-vivo
correlations, bioequivalence studies, methods to enhance the bioavailability.

UNIT- III 10 Hours

Pharmacokinetics: Introduction to Pharmacokinetics models, Compartment models, Non compartment
models, physiological models, One compartment open model. a. Intravenous Injection (Bolus) b.
Intravenous infusion, extra vascular administrations, calculations of Ka and KE. From plasma and urinary
excretion data

UNIT- IV 08 Hours
Multicompartment models: Two compartment open model. IV bolus Multiple Dosage Regimens:
a). Repititive Intravenous injections- One Compartment Open Model
b). Repititive Extravascular dosing- One Compartment Open model

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UNIT- V 07 Hours
Nonlinear Pharmacokinetics: Introduction, Factors causing Non-linearity, Michaelis-menton method of
estimating parameters,
Recommended Books: (Latest Editions)
1. Biopharmaceutics and Clinical Pharmacokinetics by, Milo Gibaldi.
2. Biopharmaceutics and Pharmacokinetics; By Robert F Notari
3. Applied biopharmaceutics and pharmacokinetics, Leon Shargel and Andrew B.C.YU 4th
edition,Prentice-Hall Inernational edition.USA
4. Bio pharmaceutics and Pharmacokinetics-A Treatise, By D. M. Brahmankar and Sunil
B.Jaiswal,Vallabh Prakashan Pitampura, Delhi
5. Pharmacokinetics: By Milo Glbaldi Donald, R. Mercel Dekker Inc.
6. Hand Book of Clinical Pharmacokinetics, By Milo Gibaldi and Laurie Prescott by ADIS Health
Science Press.
7. Biopharmaceutics; By Swarbrick
8. Clinical Pharmacokinetics, Concepts and Applications: By Malcolm Rowland and
9. Thomas, N. Tozen, Lea and Febrger, Philadelphia, 1995.
10. Dissolution, Bioavailability and Bioequivalence, By Abdou H.M, Mack, Publishing Company,
Pennsylvania 1989.
11. Biopharmaceutics and Clinical Pharmacokinetics-An introduction 4th edition Revised and expanded
by Rebort F Notari Marcel Dekker Inn, New York and Basel, 1987.
12. Remingtons Pharmaceutical Sciences, By Mack Publishing Company, Pennsylvnia

BP 605 T. PHARMACEUTICAL BIOTECHNOLOGY (Theory) 45 Hours

Scope:
Biotechnology has a long promise to revolutionize the biological sciences and technology.
Scientific application of biotechnology in the field of genetic engineering, medicine and fermentation
technology makes the subject interesting. Biotechnology is leading to new biological revolutions in
diagnosis, prevention and cure of diseases, new and cheaper pharmaceutical drugs. Biotechnology has
already produced transgenic crops and animals and the future promises lot more. It is basically a research-
based subject.
Objectives: Upon completion of the subject student shall be able to;
1. Understanding the importance of Immobilized enzymes in Pharmaceutical Industries
2. Genetic engineering applications in relation to production of pharmaceuticals
3. Importance of Monoclonal antibodies in Industries
4. Appreciate the use of microorganisms in fermentation technology
UNIT I 10 Hours
a) Brief introduction to Biotechnology with reference to Pharmaceutical Sciences.
b) Enzyme Biotechnology- Methods of enzyme immobilization and applications.
c) Biosensors- Working and applications of biosensors in Pharmaceutical Industries.
d) Brief introduction to Protein Engineering.
e) Use of microbes in industry. Production of Enzymes- General consideration - Amylase, Catalase,
Peroxidase, Lipase, Protease, Penicillinase.
Basic principles of genetic engineering.
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UNIT II 10 Hours
a) Study of cloning vectors, restriction endonucleases and DNA ligase.
b) Recombinant DNA technology. Application of genetic engineering in medicine.
c) Application of r DNA technology and genetic engineering in the products: i) Interferon ii) hepatitis- B
vaccine iii) Insulin hormone.
d) Brief introduction to PCR
e) Types of immunity- humoral immunity, cellular immunity

UNIT III 10 Hours

a) Structure of Immunoglobulins
b) Structure and Function of MHC
c) Hypersensitivity reactions, Immune stimulation and Immune suppressions.
d) General method of the preparation of bacterial vaccines, toxoids, viral vaccines, antitoxins, serum-
immuno blood derivatives and other products relative to immunity.
e) Storage conditions and stability of official vaccines
f) Hybridoma technology- Production, Purification and Applications
UNIT IV 08 Hours
a) Immuno blotting techniques- ELISA, Western blotting, Southern blotting.
b) Microbial genetics including transformation, transduction, conjugation, plasmids and transposons.
c) Introduction to Microbial biotransformation and applications.

UNIT V 07 Hours
a) Mutation --Types of mutation/mutants
b) Fermentation methods and general requirements, study of media, equipments, sterilization methods,
aeration process, stirring.
c) Large scale production fermenter design and its various controls.
d) Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic acid, Griseofulvin,
e) Blood products: Collection, Processing and Storage of whole human blood, dried plasma, plasma
substitutes

Recommended Books (Latest edition):

1. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applications of Recombinant
DNA: ASM Press Washington D.C.
2. RA Goldshy et. al., : Kuby Immunology.
3. J.W. Goding: Monoclonal Antibodies.
4. J.M. Walker and E.B. Gingold: Molecular Biology and Biotechnology by Royal Society of
Chemistry.
5. Zaborsky: Immobilized Enzymes, CRC Press, Degraland, Ohio.
6. S.B. Primrose: Molecular Biotechnology (Second Edition) Blackwell Scientific Publication.
7. Stanbury F., P., Whitakar A., and Hall J., S., Principles of fermentation technology, 2nd edition,
Aditya books Ltd., New Delhi

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BP606 T PHARMACEUTICAL QUALITY ASSURANCE (Theory) 45 Hours

Scope: This course deals with the various aspects of quality control and quality assurance aspects of
pharmaceutical industries. It covers the important aspects like cGMP, QC tests, documentation, quality
certifications and regulatory affairs.
Objectives: Upon completion of the course student shall be able to:
1. understand the CGMP aspects in a pharmaceutical industry appreciate the importance of
documentation
2. understand the scope of quality certifications applicable to pharmaceutical industries
3. understand the responsibilities of QA & QC departments

Course content:
UNIT I 10 Hours
Quality Assurance and Quality Management concepts: Definition and concept of Quality control,
Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special
emphasis on Q-series guidelines, ICH stability testing guidelines
Quality by design (QbD): Definition, overview, elements of QbD program, tools
ISO 9000 & ISO 14000: Overview, Benefits, Elements, steps for registration
NABL accreditation : Principles and procedures.
UNIT – II 10 Hours
Organization and personnel: Personnel responsibilities, training, hygiene and personal records.
Premises: Design, construction and plant layout, maintenance, sanitation, environmental control, utilities
and maintenance of sterile areas, control of contamination.
Equipments and raw materials: Equipments selection, purchase specifications, maintenance, purchase
specifications and maintenance of stores for raw materials.
Warehousing: Good warehousing practice, materials management
UNIT III 10 Hours
Quality Control: Quality control test for containers, rubber closures and secondary packing materials.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment,
Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory
Study, Records and Reports, Disqualification of Testing Facilities
UNIT IV 08 Hours
Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and waste
disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record,
SOP, Quality audit, Quality Review and Quality documentation, Reports and documents, distribution
records.
UNIT V 07 Hours
Calibration and Validation: Introduction, definition and general principles of calibration, qualification
and validation, importance and scope of validation, types of validation, validation master plan.
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Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical
method Validation.

Recommended Books: (Latest Edition)

1. Quality Assurance Guide by organization of Pharmaceutical Products of India.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69.
3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol I
WHO Publications.
4. A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh
5. How to Practice GMPs P P Sharma.
6. ISO 9000 and Total Quality Management Sadhank G Ghosh
7. The International Pharmacopoeia Vol I, II, III, IV- General Methods of Analysis and Quality
specification for Pharmaceutical Substances, Excipients and Dosage forms
8. Good laboratory Practices Marcel Deckker Series
9. ICH guidelines, ISO 9000 and 14000 guidelines.

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