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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 BP606TPHARMACEUTICAL QUALITY ASSURANCE (Theory)
45 Hours
Scope: This course deals with the various aspects of quality control and quality
assurance aspects of pharmaceutical industries. It deals with the important aspects like
cGMP, QC tests, documentation, quality certifications and regulatory affairs.
Objectives: Upon completion of the course student shall be able to:
 understand the cGMP aspects in a pharmaceutical industry
 appreciate the importance of documentation
 understand the scope of quality certifications applicable to pharmaceutical
industries
 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 & ISO14000: 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: Equipment selection, purchase specifications, maintenance,
purchase specifications and maintenance of stores for raw materials.

UNIT – III 10 Hours

Quality Control: Quality control test for containers, rubber closures and secondary packing

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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. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General
principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management

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 GMP’s – 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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SEMESTER VII

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 BP701T. INSTRUMENTAL METHODS OF ANALYSIS (Theory)
45 Hours
Scope: This subject deals with the application of instrumental methods in qualitative and
quantitative analysis of drugs. This subject is designed to impart a fundamental
knowledge on the principles and instrumentation of spectroscopic and chromatographic
technique. This also emphasizes on theoretical and practical knowledge on modern
analytical instruments that are used for drug testing.

Objectives: Upon completion of the course the student shall be able to

1. Understand the interaction of matter with electromagnetic radiations and its
applications in drug analysis
2. Understand the chromatographic separation and analysis of drugs.
3. Perform quantitative & qualitative analysis of drugs using various analytical
instruments.

Course Content:

UNIT –I 10 Hours

UV Visible spectroscopy
Electronic transitions, chromophores, auxochromes, spectral shifts, solvent effect on
absorption spectra, Beer and Lambert’s law, Derivation and deviations.
Instrumentation - Sources of radiation, wavelength selectors, sample cells, detectors-
Photo tube, Photomultiplier tube, Photo voltaic cell, Silicon Photodiode.
Applications - Spectrophotometric titrations, Single component and multi component
analysis
Fluorimetry
Theory, Concepts of singlet, doublet and triplet electronic states, internal and external
conversions, factors affecting fluorescence, quenching, instrumentation and
applications

UNIT –II 10 Hours

IR spectroscopy
Introduction, fundamental modes of vibrations in poly atomic molecules, sample
handling, factors affecting vibrations
Instrumentation - Sources of radiation, wavelength selectors, detectors - Golay cell,
Bolometer, Thermocouple, Thermister, Pyroelectric detector and applications
Flame Photometry-Principle, interferences, instrumentation and applications

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Atomic absorption spectroscopy- Principle, interferences, instrumentation and
applications
Nepheloturbidometry- Principle, instrumentation and applications

UNIT –III 10 Hours

Introduction to chromatography
Adsorption and partition column chromatography-Methodology, advantages,
disadvantages and applications.
Thin layer chromatography- Introduction, Principle, Methodology, Rf values,
advantages, disadvantages and applications.
Paper chromatography-Introduction, methodology, development techniques,
advantages, disadvantages and applications
Electrophoresis– Introduction, factors affecting electrophoretic mobility, Techniques
of paper, gel, capillary electrophoresis, applications

UNIT –IV 08 Hours

Gas chromatography - Introduction, theory, instrumentation, derivatization,

temperature programming, advantages, disadvantages and applications
High performance liquid chromatography (HPLC)-Introduction, theory,
instrumentation, advantages and applications.

UNIT –V 07 Hours

Ion exchange chromatography- Introduction, classification, ion exchange resins,

properties, mechanism of ion exchange process, factors affecting ion exchange,
methodology and applications
Gel chromatography- Introduction, theory, instrumentation and applications
Affinity chromatography- Introduction, theory, instrumentation and applications

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 BP705P. INSTRUMENTAL METHODS OF ANALYSIS (Practical)
4 Hours/Week
1 Determination of absorption maxima and effect of solvents on absorption
maxima of organic compounds
2 Estimation of dextrose by colorimetry
3 Estimation of sulfanilamide by colorimetry
4 Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy
5 Assay of paracetamol by UV- Spectrophotometry
6 Estimation of quinine sulfate by fluorimetry
7 Study of quenching of fluorescence
8 Determination of sodium by flame photometry
9 Determination of potassium by flame photometry
10 Determination of chlorides and sulphates by nephelo turbidometry
11 Separation of amino acids by paper chromatography
12 Separation of sugars by thin layer chromatography
13 Separation of plant pigments by column chromatography
14 Demonstration experiment on HPLC
15 Demonstration experiment on Gas Chromatography

Recommended Books (Latest Editions)

1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth 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

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 BP 702 T. INDUSTRIAL PHARMACYII (Theory)
45 Hours
Scope: This course is designed to impart fundamental knowledge on pharmaceutical
product development and translation from laboratory to market
Objectives: Upon completion of the course, the student shall be able to:
1. Know the process of pilot plant and scale up of pharmaceutical dosage forms
2. Understand the process of technology transfer from lab scale to commercial batch
3. Know different Laws and Acts that regulate pharmaceutical industry
4. Understand the approval process and regulatory requirements for drug products
Course Content:

UNIT-I 10 Hours
Pilot plant scale up techniques: General considerations - including significance of
personnel requirements, space requirements, raw materials, Pilot plant scale up
considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC
guidelines, Introduction to platform technology

UNIT-II 10 Hours
Technology development and transfer: WHO guidelines for Technology Transfer(TT):
Terminology, Technology transfer protocol, Quality risk management, Transfer from R
& D to production (Process, packaging and cleaning), Granularity of TT Process (API,
excipients, finished products, packaging materials) Documentation, Premises and
equipments, qualification and validation, quality control, analytical method transfer,
Approved regulatory bodies and agencies, Commercialization - practical aspects and
problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE /
SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs,
legal issues

UNIT-III 10 Hours
Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory
authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs
Professionals
Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical
Drug Development, Pharmacology, Drug Metabolism and Toxicology, General
considerations of Investigational New Drug (IND) Application, Investigator’s Brochure
(IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research
Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for
FDA Submissions, Management of Clinical Studies.

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 UNIT-IV 08 Hours
Quality management systems: Quality management & Certifications: Concept of
Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out
of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality
systems standards, ISO 14000, NABL, GLP
UNIT-V 07 Hours
Indian Regulatory Requirements: Central Drug Standard Control Organization
(CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of
Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for
New Drugs.

Recommended Books: (Latest Editions)

1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available
at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
2. International Regulatory Affairs Updates, 2005. available at
http://www.iraup.com/about.php
3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide
for Prescription Drugs, Medical Devices, and Biologics’ Second Edition.
4. Regulatory Affairs brought by learning plus, inc. available at
http.//www.cgmp.com/ra.htm.

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 BP 703T. PHARMACY PRACTICE (Theory)

45 Hours

Scope: In the changing scenario of pharmacy practice in India, for successful practice of
Hospital Pharmacy, the students are required to learn various skills like drug distribution,
drug information, and therapeutic drug monitoring for improved patient care. In
community pharmacy, students will be learning various skills such as dispensing of
drugs, responding to minor ailments by providing suitable safe medication, patient
counselling for improved patient care in the community set up.

Objectives: Upon completion of the course, the student shall be able to

1. know various drug distribution methods in a hospital

2. appreciate the pharmacy stores management and inventory control
3. monitor drug therapy of patient through medication chart review and clinical
review
4. obtain medication history interview and counsel the patients
5. identify drug related problems
6. detect and assess adverse drug reactions
7. interpret selected laboratory results (as monitoring parameters in therapeutics) of
specific disease states
8. know pharmaceutical care services
9. do patient counseling in community pharmacy;
10. appreciate the concept of Rational drug therapy.

Unit I: 10 Hours
a) Hospital and it’s organization
Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals,
Classification based on clinical and non- clinical basis, Organization Structure of a
Hospital, and Medical staffs involved in the hospital and their functions.

b) Hospital pharmacy and its organization

Definition, functions of hospital pharmacy, Organization structure, Location, Layout

and staff requirements, and Responsibilities and functions of hospital pharmacists.

c) Adverse drug reaction

Classifications - Excessive pharmacological effects, secondary pharmacological
effects, idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity
following sudden withdrawal of drugs, Drug interaction- beneficial interactions,
adverse interactions, and pharmacokinetic drug interactions, Methods for detecting

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 drug interactions, spontaneous case reports and record linkage studies, and Adverse
drug reaction reporting and management.

d) Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design, Legal
requirements for establishment and maintenance of a drug store, Dispensing of
proprietary products, maintenance of records of retail and wholesale drug store.

Unit II: 10 Hours

a) Drug distribution system in a hospital
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy
and labelling, Dispensing of drugs to ambulatory patients, and Dispensing of
controlled drugs.

b) Hospital formulary
Definition, contents of hospital formulary, Differentiation of hospital formulary and
Drug list, preparation and revision, and addition and deletion of drug from hospital
formulary.

c) Therapeutic drug monitoring

Need for Therapeutic Drug Monitoring, Factors to be considered during the
Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug Monitoring.

d) Medication adherence
Causes of medication non-adherence, pharmacist role in the medication adherence,
and monitoring of patient medication adherence.

e) Patient medication history interview

Need for the patient medication history interview, medication interview forms.

f) Community pharmacy management

Financial, materials, staff, and infrastructure requirements.

Unit III: 10 Hours

a) Pharmacy and therapeutic committee
Organization, functions, Policies of the pharmacy and therapeutic committee in
including drugs into formulary, inpatient and outpatient prescription, automatic stop
order, and emergency drug list preparation.

b) Drug
information services

150
 Drug and Poison information centre, Sources of drug information, Computerised
services, and storage and retrieval of information.

c) Patient
counseling
Definition of patient counseling; steps involved in patient counseling, and Special
cases that require the pharmacist

d) Education and training program in the hospital

Role of pharmacist in the education and training program, Internal and external
training program, Services to the nursing homes/clinics, Code of ethics for community
pharmacy, and Role of pharmacist in the interdepartmental communication and
community health education.

e) Prescribed medication order and communication skills

Prescribed medication order- interpretation and legal requirements, and
Communication skills- communication with prescribers and patients.

Unit IV 8 Hours
a) Budget
preparation and implementation
Budget preparation and implementation

b) Clinical Pharmacy
Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and
responsibilities of clinical pharmacist, Drug therapy monitoring - medication chart
review, clinical review, pharmacist intervention, Ward round participation, Medication
history and Pharmaceutical care.
Dosing pattern and drug therapy based on Pharmacokinetic & disease pattern.

c) Over the counter (OTC) sales

Introduction and sale of over the counter, and Rational use of common over the
counter medications.

Unit V 7 Hours
a) Drug store management and inventory control
Organisation of drug store, types of materials stocked and storage conditions, Purchase
and inventory control: principles, purchase procedure, purchase order, procurement
and stocking, Economic order quantity, Reorder quantity level, and Methods used for
the analysis of the drug expenditure

b) Investigational use of drugs

151