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AC 24 -06-2016
Item No. 4.66
UNIVERSITY OF MUMBAI
Syllabus for Sem I and Sem II, M.Voc
Program: M.Voc
Course : PHARMA ANALYTICAL
SCIENCES
(To be Introduced Choice Based Credit System with
effect from the academic year 2016-17)
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Preamble:
Indian Pharmaceutical industry:
India accounts for 7% of the GDP by chemical sector and 11% of the national export. There are about 20000
registered pharmaceutical units in India and there are about 250 large units, 8000 small scale units and 5 central public sector units. Additionally, the size of the Indian diagnostic and lab services is about 160 billion.
Not marred by recession or inflation, the pharma sector has a competitive advantage of prospering steadily
and thus attracts lots of young professionals looking at pharmaceutical as their prospective career option.
With the expected growth rate of 14% per annum, Indian Pharmaceutical sector is expected to create more
jobs in India in near future and add 45,000 fresh openings to its current strength. Since 2009- 10 more than 900 new drug approvals have been given by the Indian drug regulator. The
regulatory guidelines have been revised since the Supreme Court directives in 2011 -12. Regulatory
requirements are increasing in production, quality control and R & D laboratories. Therefore, the regulatory
department in a Pharmaceutical company not only needs a very broad understanding of the regulatory
requirements but also must understand the chemical processes of production and quality control, the
analytical tests, the pre -clinical stud ies and the clinical trial reports. Further there is an international strategy
to harmonize the guidelines using ICH. With about 25 leading pharmaceuticals and about 100 smaller units involved in exports the requirement of regulatory executives is constantly increasing. Some of the top Indian pharmaceuticals have more than 75 executives employed in the regulatory department alone.
The need to develop trained employable human resource:
The Indian Pharmaceutical and Chemical Industry have always been experiencing a dearth of skilled and industrially oriented human resource. The Industry despite employing students from chemistry, biology and pharmacy background always spends 6 months to one year for training the students for general industry needs like Good Laboratory Practices, Good Documentation Practices and regulatory compliances. The
important component of knowledge and implementation of quality in laboratory analysis is scarce in the graduates of chemistry and pharmacy. The skilled manpower requirement is in the areas of R & D, quality
assurance and intellectual property. The Pharmaceutical industry sector in India is the one of the strong
Export oriented sectors that needs to comply with a multitude of regulatory compliances for marketing the drug formulations abroad. In India itself, the sector needs to comply to stringent regulatory compliances and audits before the drug formulations are marketed. The training in practice of GLP as per the current regulatory requirements is missing. This course will provide manpower that is work- ready.
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Objectives of the Course
The course will address the requirements of conducting, managing and meeting regulatory
requirements for R & D and testing laboratories in pharmaceutical and chemical industries. Major hurdle faced
by the R&D centers at various Pharma laboratories is the lack of adequately trained and GLP oriented
personnel. This forms a major setback when the application of sophisticated technology especially in the bio analytical field is concerned. The lacu nae become more evident when dealing with newer dosage forms and
peptide based drugs. This lacunae needs to addressed very diligently and the proposed programme is a step in
this direction
The program will have the following objectives;
• To develop traine d manpower in the field of Pharma Analytical Sciences with specific emphasis for
instrumentation skills needed for analysis
• To amalgamate knowledge of classical analytical techniques with modern sophisticated instrumentation
and provide training in the analysis of chemicals, drugs, food and other products.
• To introduce the training with powerful tools of instrumentation analysis in routine analysis at
manufacturing, QC and research
• To provide exposure to National & International regulatory requirements with reference to drugs and
chemicals
• To provide training in skills of analysis and develop knowledgeable and employable human resource
• To provide training in soft skills for efficient communication, technical writing, entrepreneurship and
basic business management,
O._______ Eligibility :
• B.Sc. in any one of the following subjects: Chemistry, Botany, Zoology, Microbiology,
Lifes cience, Biochemistry, Biotechnology Bioanalytical Sciences and have offered
Chemistry as one of the subject till S Y B Sc (total 5 units) or equivalent.
• No age bar
R.________ Duration: FOUR semesters (Two Years)
R.________ No of Lectures: 4 theory papers each semester equivalent to 3 credits each.
45 lectures for each paper per semester.
R.________ No of Practical periods: 1 practical paper for the skill component equivalent to 08 credits
and one practical for the general education component equivalent
to 04 credits in each semester.
360 hours for each practical per semester.
R.________ No. of credits: 14 credits of Skill component and 10 credits of general education component
at each semester. Total 24 credits per semester.
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University of Mumbai
Credit Based, Semester & Grading System
SYLLABUS IN BRIEF : M.VOC , PHARMA ANALYTICAL SCIENCES :
Semester - I
Code Paper Credits Lectures L/Wk
Skill Component
PVPAS101 Standardization and validation of
methods & Pharmacopeial method of
analysis 3 45 4
PVPAS102 Total quality management and its practice 3 45 4
PVPASP101 Practical based on Skill Components ,
Industrial visits and assignments 8 240 10
General Education Component
PVPAS103 Basic ele ctronics , Basic chromatography
and their applications 3 45 4
PVPAS104 Entrepreneurship skill 3 45 4
PVPASP102 Practical based on General Education Components 4 120 5
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Semester - II
Code Paper Credits Lectures L/Wk
Skill Component
PVPAS201 Biological methods of testing, Analysis of
various formulations & their reporting 3 45 4
PVPAS202 Statistics and its applications 3 45 4
PVPASP201 Practical based on Skill Components
Industrial visits and assignments 8 240 10
General Education Component
PVPAS203 Advanced techniques of instrumental
analysis & Basic concepts of laboratory
management 3 45 4
PVPAS204 Industrial Training / assignments 3 45 4
PVPAS202 Practical based on General Education Components 4 120 5
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Semester - III
Code Paper Credits Lectures L/Wk
Skill Component
PVPAS301 Hyphenated techniques for analysis,
Laboratory accreditation and laboratory audits 3 45 4
PVPAS302 Statistical software and their applications
3 45 4
PVPASP301 Practical based on Skill Components
Industrial visits and assignments 8 240 10
General Education Component
PVPAS303 Laboratory data, integrity, security ,
archival & Special techniques of sample
processing (e.g. Proteins) 3 45 4
PVPAS304 Skills of project management and practice of GMP 3 45 4
PVPASP302 Practical based on General Education Components 4 120 5
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Semester - IV
Code Paper Credits Lectures L/Wk
Skill Component
PVPAS401 Specialized requirements of analysis (e.g.
food and pesticides, stability, laboratory information management etc) 3 45 4
PVPAS402 Analysis of pharmaceutical and cosmetic formulations 3 45 4
PVPASP401 Practical based on Skill Components
Industrial visits and assignments 8 240 10
General Education Component
PVPAS403 Analys is for forensics, water quality,
detergents and treatment of laboratory
waste water 3 45 4
PVPAS404 Industrial Training // Internship 3 45 4
PVPASP402 Practical based on General Education Components 4 120 5
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SYLLABUS IN DETAIL
Code Paper Credits Lectures L/Wk
Skill Component
PVPAS101 Standardization and validation of
methods & Pharmacopeial method of
analysis 3 45 4
• Basic electronics and
applications
• Detectors, transducers and
sensors
• Limits and Range of Detection
• Validation of methods
• Atomic absorption
spectroscopy and applications
PVPAS102 Total quality management and its practice 3 45 4
• Theory and Practice of QA and
QC
• Quality Audits and
Compliances
• Calibration and Calibration
records
• Standard Operating procedures
and their implementation
PVPASP101 Practical based on Skill Components
Industrial visits and assignments 8 240 10
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Code Paper Credits Lectures L/Wk
General Education Component
PVPAS103 Basic ele ctronics , Basic chromatography
and their applications 3 45 4
• Types of Instrumental methods
• Selection of analytical method
• Measurement of uncertainty
• Analytical Standards and
concept of purity
• Basics of Chromatographic
Technique
PVPAS104 Entrepreneurship skill 3 45 4
• Scope of analytical services
• Laboratory design and
Laboratory setup
• Total Quality Management
• Quantitation Techniques and
its Reporting
• Financial Aspects of Quality
Systems
PVPASP102 Practical based on General Education
Components 8 240 10
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Code Paper Credits Lectures L/Wk
Skill Component
PVPAS201 Biological methods of testing, Analysis of
various formulations & their reporting 3 45 4
• Biological testing as per IP
• Microbiological test for sterility
• Capillary Electrophoresis
• FTIR
• Analysis of powders, creams
and lotions
• Analysis of Water (Physico
Chemical parameters
PVPAS202 Statistics and its applications 3 45 4
• Application of Statistics in Data
Analysis
• Basic Economics and Business
Economics
• Start -up Projects & Start -up
Financing
PVPASP201 Practical based on Skill Components
Industrial visits and assignments 8 240 10
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Code Paper Credits Lectures L/Wk
General Education Component
PVPAS203 Advanced techniques of instrumental
analysis & Basic concepts of laboratory
management 3 45 4
• Fourier transformation and its
application
• GLP and its practice
• Laboratory Safety
• Waste disposal and waste
management
• Theory and Practical of
Electrophoresis
• Impurity profiling of Raw
Materials
• Intellectual Property Rights and
Patents
• Plastics and Polymers
• Perspectives of Society to
Technology and Development
PVPAS204 Industrial Training / assignments 3 45 4
• Students placement in industry
PVPAS202 Practical based on General Education
Components 4 120 5
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Code Paper Credits Lectures L/Wk
Skill Component
PVPAS301 Hyphenated techniques for analysis,
Laboratory accreditation and laboratory audits 3 45 4
• GC-MS
• LC-MS
• ICP and ICP -MS
• NMR and its application
PVPAS302 Statistical software and their applications
3 45 4
• Electronic interfaces for data
acquisition
• SAS and its application
• Project Management Skills
PVPASP301 Practical based on Skill Components
Industrial visits and assignments 8 240 10
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Code Paper Credits Lectures L/Wk
General Education Component
PVPAS303 Laboratory data, integrity, security ,
archival & Special techniques of sample
processing (e.g. Proteins) 3 45 4
• Laboratory information
management systems
• Data Integrity and Data
Security
• Data Archival and Retrieval
• Hyphenated techniques and
their applications
• Dialysis and protein purification
• GCP and its practice
PVPAS304 Skills of project management and practice
of GMP 3 45 4
• Planning and Execution of Data
Management
• Change Control and its practice
• Laboratory accreditations –
ISO, NABL etc
• Regulatory compliances for
GMP and its certification
PVPASP302 Practical based on General Education Components 4 120 5
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Code Paper Credits Lectures L/Wk
Skill Component
PVPAS401 Specialized requirements of analysis (e.g.
food and pesticides, stability, laboratory
information management etc) 3 45 4
• Analysis of Food and Food
products
• Pesticide Analysis
• Application of ICT in laboratory
management
• Critical thinking and soft skills
PVPAS402 Analysis of pharmaceutical and cosmetic
formulations 3 45 4
• Pharmaceutical and Cosmetic
Formulations
• Financial Management
(Including Micro Finance)
• Human Resource Management
PVPASP401 Practical based on Skill Components
Industrial visits and assignments 8 240 10
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Code Paper Credits Lectures L/Wk
General Education Component
PVPAS403 Analysis for forensics, water quality,
detergents and treatment of laboratory waste water 3 45 4
• Analytical chemistry in
forensics
• Detergents and Pesticides
• Environmental Audit and its
significance
• Environmental legislation and
acts
• Waste water treatment and
solid waste management
• Principles and concepts of
Green Chemistry
• Bioremediation and their
implementation
• Stability studies and their
significance
• Conservation of resources and
recycling
PVPAS404 Industrial Training // Internship 3 45 4
PVPASP402 Practical based on General Education
Components 4 120 5
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MVoc – Pharma Analytical Sciences
LIST OF PRACTICAL TO BE COVERED IN FOUR SEMESTERS
Orientation Practical : This will include introduction to GLP, IP and regulatory
requirements. Basic laboratory skills and instrument calibration.
• Basic laboratory skills
Use of analytical balance
pH meter
Colorimeter
Spectrophotometer
Safety symbols
Fire safety and Safety equipment
General Laboratory SOPs and documentations
• Spectroscopy
Visible
uV
IR
Calibration, quantitation and preventive maintenance
• Evaluation of Physical characteristics, proximate analysis
APIs
Medicinal plant raw materials
Formula tions
• Validation of a pharmacopeial method :
HPTLC Method(s)
HPLC Method(s)
GC Method(s)
Linearity, LOD, and QC levels
Accuracy & Precision
System suitability
Extraction efficiency
Stability of Stock solutions
Bench top stability
Long and short term stability
Ruggedness
Robustness
Method transfer
• Quality system
SOPs
Structure
Control of SOPs
Distribution and Review
Archival and discard
SOP training
• Writing and Preparing SOP –
HPTLC
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HPLC
Column Efficiency
GC
• Identification of basic electronic compone nts
Diod
Transistor
Resistance
Ics
Capacitor etc.
Preparing a simple circuit and placing on circuit board.
• Preparing a wired switchboard with switches, fuse and main supply indicators
• Animal handling
Weighing
Oral Gavage
Injections – IV, IM and IP
Animal cage cleaning and feeding
Recording cage side observations
Animal tagging
Animal grouping
Rats, Mice, guinea pigs, Rabbits
• Test for undue toxicity
• Pyrogen testing using rabbit
• Pyrogen testing using LAL test
• Dermal irritation studies
• From 39 and its usage
• Student t test
• ANOVA with F test, two way, three way etc.
• Chi square test and evaluation
• Practice of basic chromatographic techniques ;
TLC
HPTLC
HPLC
GC
Extraction – liq-liq and SPE
Usage of LV evaporator
Column oven
• LC – MS basic instrumentation and control
• LC-MS Quantitaion
• Impurity profiling in MS
• Mass evaluation of components after LC separation
• Mass using quqpdapole
• GC- MS method
• GC-MS library usage
• Head Space GC demonstration
• Method development ;
• HPLC for LC -MS
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• GC for GC -MS
• Usage of statistical software like – WinNonLin, SPSS, SAS etc.
• CE and CE analysis of antibiotics, proteins, ascorbic acid and heparin etc.
• Electrophoresis separation of protein mixtures, nucleic acid mixtures
• Evaluation of following formulations for physical and chemical charac teristics;
Syrups
Ointments
Creams
Gels
Sprays etc
• uV protection evaluations for SPF value
• Tablet dissolution studies for immediate release and delayed release
• Water analysis for quality, potability and contaminants
• Analysis of foods, and beverages for pesticide residue, Heavy metals etc.
• Practical in Green chemistry for understanding concepts and applications
• Bioanalysis of analytes from human samples; sweat, blood, plasma etc.
• Waste water analysis
BOD
COD
DO
Other physico -chemical parameters
• Analysis o f detergents for various stadtrd specifications
• Analysis of oils :
Sap value
Iodine value
Acid value
GC analysis of oils for fatty acids, petroleum fractions etc
• Statistics
Randomisation
DOE
Bioequivalence
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The Scheme of Examination and Allotment of marks are tabulated below;
M. VOC. (PHARMACEUTICAL ANALYSIS)
(600 MARKS PER SEMESTER)
THEORY (FOUR PAPERS)
PRACTICAL (FOUR PAPERS)
MARKS MARKS
SC-1 100 SC-1 50
SC-2 100 SC-2 50
SC-3 100 SC-3 50
GC-1 (GENERAL) 100 GC-1 50
TOTAL MARKS 400 200
GRAND TOTAL 600
NOTE : SC= Skilled Component, GC= General Component
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