SNDT Women's University - Shreemati Nathibai Damodar ...

SNDT Women’s University
(Sndt.digitaluniversity.ac)
Syllabus – M. Pharm. (Quality Assurance)
SNDT Women’s University
1, Nathibai Thackersey Road,
Mumbai 400 020
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C. U. SHAH COLLEGE OF PHARMACY
ABOUT THE COLLEGE
The S.N.D.T. Women’s University established in 1916, was founded by Maharshi
Karve and nurtured by Sir Vithaldas Thackersey especially by Lady Premlila
Thackersey and other dedicated social workers, who believed in women’s full
participation in all spheres of life. Its expansion included offering of Graduate and
Post-Graduate courses in Arts, Commerce, Home Science, Library Science, Nursing
and Education, Pharmacy & Engineering, in addition to Diploma courses in various
fields. A diploma course in Pharmacy was started in 1976 in P.V. Polytechnic at
Juhu Campus.
Befitting with the objectives of the University and due to the repaid changes taking
place in society, where in more girls are opting for professional courses, a number
of professional courses are introduced by the university from time to time. A full
fledged degree course in Pharmacy at its C.U. SHAH College of Pharmacy was in
1980, with the generous donation of Rs. 5 Lacs from C.U.SHAH Charitable Trust.
The college now offers the following programmes and courses:
• Four Year – Bachelor of Pharmacy (B.Pharm)
• Four Semester – Master of Pharmacy (QA) (M. Pharm)
Four Semester - Master of Pharmacy in Pharmaceutics (Industrial
Pharmacy)
• One Year P.G. Diploma in Pharm Analysis.
• One Year P.G. Diploma in Cosmeticology.
• Doctor of Philosophy in Pharmacy (Tech.).
Facilities available to the college include.
• C.U. Shah Pharmaceutical Research Centre.
• Industrial Pharmacy Laboratory.
• Centre for bioavailability studies.
• Consultancy & Guidance to Pharmaceutical Industry.
Research Projects are undertaken from Pharma Industries and State and Central
government agencies like
-U.G.C., M. H.R.D.
-C.S.I.R., B.R.N.S., DAE, DBT.
B.A.R.C. etc.
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The M. Pharm. (Quality Assurance) course, a very unique one was introduced in India for the
FIRST TIME in 1989 at C.U. Shah College of Pharmacy, by SNDT Women’s University after
due sanction from the University Grants Commission and AICTE. The course is devised with a
focus on the aptitude, talents and job potential for women in pharma industry and research and
development institutes.
The is a four semester programme with the following specific features.
1) Emphasis on modern analytical techniques like spectroflurometry, infrared
spectrophotometry, NMR, Spectromentry HPLC, X-ray diffraction analysis and spectral
analysis.
2) Thrust on good manufacturing practices, quality audits, documentation and validation with a
view to create total quality consciousness.
3) Packaging and product development courses designed to teach current trends in formulation
of pharmaceuticals and newer drug delivery systems.
4) Students work on a research project and submit a dissertation at the end of fourth semester
for which they are evaluated by experts.
5) One month in plant training in industry to correlate theory with professional practice.
6) Guest lectures and seminars are routinely arranged where visiting faculty impart insights in
state-of-art technology and current advances in pharmaceutical sciences.
HOSTEL :
Very limited accommodation is available in the University Hostel, situated in the campus.
ADMISSIO CRITERIA :
Only Female candidates shall be admitted for the Ten open merit seats, 5 for sponsored and
three reserved category. seats Out of ten seats one is reserved for Marathwada University
students. The admission to these seats will be as per rules of AICTE/DTE/ University.
Admission will be given on purely merit basis to candidates with valid gate score & a minimum
of (60% marks at B.Pharm. Degree).
Five seats are for sponsored candidates.
Minimum 60% marks at B. Pharm.
Reservation only for 2 S.C. + 1 S.T. Candidate is prioded.
A letter from the sponsor regarding the payment of sponsorship should accompany with the
application form.
Preference will be given to SNDT Women’s University Students.
Any additional rules prescribed by the AICTE or SNDT Women’s University will be applicable.
ATTEDACE REQUIRED :
(a) A candidate shall be required to attend at least 75% of the number of lectures and the
number of practicals separately for each subject to study in each semester, and only then,
subject to other conditions being fulfilled be eligible to appear at the University
Examinations.
(b) The Principal of the college will have the discretion to condone 10% of the attendance in
Theory and / or Practicals of any one subject or subjects if he is fully convinced of the
student’s absence on ground of health or for reasons beyond his control.
(c) The SNDT Women’s University however, reserves its right to condone the additional
absence, if fully represented by the student and recommended by the Principal.Each student
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shall be required to pass theory & practical examination which will be held at the end of
each semester.
Semester 1 and Semester II Each will be of 15 weeks duration.
Pattern of Examination :
The examination at the end of Semester I & II will be conducted by the SNDT Women’s
University. At the end of semester IV, a viva-voice examination based on the research project and
dissertation work submitted by the student will be conducted. There will not be any examination
(internal or University) for two subject heads viz practicals in computing and statistics and
spectral workshop.
Internal assessment :
There will be an internal assessment to the tune of 20% marks in each subject separately for
theory and practicals. One periodic test of 20 marks will be conducted in given subjects during
each semester.
No repeat unit test in theory or practicals will be GIVEN.
Standard of passing :
(a) A candidate shall obtain at least 50% marks (internal assessment and semester examination
combined) separately in theory and practical of each subject for passing in the University
examination. Failure to pass the semester I examination will not disqualify a candidate for
presenting herself on a subsequent occasion. On a new application being forwarded and
fresh fees paid, such a candidate will be allowed to keep terms and appear for the semester
II examination, not withstanding the fact that she may not have cleared the semester I
examination. A candidate who has failed to pass the Semester I or II examinations may
present herself on a subsequent occasion on a new application being forwarded and fresh
fee paid.
Every candidate is allowed to continue her research work and submit a thesis for the
award of degree in accordance with the relevant regulations but the result of the thesis will not be
declared until she has cleared all the examinations previous.
Every candidate registered for the degree of M. Pharm. shall be required to carry out
research under the supervision and guidance of a recognized University teacher. Whole or a part
of the research work could also be carried out in a research institution to be approved by the
Principal. The research project shall be assigned within one month of the beginning of semester
I. Two type-written copies of the thesis embodying the results of research project, ordinarily not
exceeding 100 pages, together with a synopsis and a statement indicating to what extent this work
is original, shall be submitted by the candidate to the principal, through her guiding teacher. The
thesis shall be the candidate’s own work carried out under the guidance or supervision of her
teacher and shall be submitted at the end of Semester IV. Provided further that a candidate who
has submitted a synopsis of the thesis but is unable to produce the thesis under circumstances
satisfying the Research Guide on the recommendation of the Research guide and the Principal,
the thesis may be allowed to be submitted upto the end of the fifth term as a special case.
At least two months before submitting her thesis, but not later than end of semester IV
a candidate shall forward to the Principal, through the guide under whom she has worked or by
whom she has been guided, a statement giving a title & synopsis of the thesis along with
application form and fee prescribed by the University. In the synopsis, the candidate shall
indicate the broad outline of the work carried out by her.
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Every candidate shall submit a certificate signed by the research guide
under whom she has worked stating that there is a prime facie case for consideration
of the thesis.
The thesis shall be referred for examination and reported to two referees,
to be appointed by the University, on the recommendation of the Ad-hoc Board of
Studies in Pharmacy and one of the referees being always the guiding teacher. The
referees shall jointly hold a viva-voce examination which shall be held only after
the thesis has been evaluated by both the referees. The referees to whom the thesis
is referred and report, shall, after evaluating the thesis and holding a joint viva-voce
examination, to the University whether the thesis shall be accepted or rejected and
their report shall be final. In case there is a difference of opinion between the
examiners, the University shall appoint a third referee, and shall decide whether the
degree is to be conferred or not after considering the reports of all the three
referees.
Provided that the thesis is accepted for the degree, it shall be given a
grade, viz “A” ( very good ) or “B” (satisfactory). The grade to be awarded shall be
decided by the referees jointly depending on the quality and the presentation of the
research work and the performance at the viva-voca examination.
Successful candidate shall be awarded class, as under, jointly on the basis
of the results of the Semester I & II examinations and the thesis submitted by her.
1 Those obtaining 65% or more marks out of the grand
total at both the Semester I & Semester II examinations
taken together and grade “A” in the thesis
2 Those obtaining 65% or more marks out of the grand
total at both the Semester I & Semester II examinations
taken together and grade “B” in the thesis
3 Those obtaining 55% to 64.99% marks out of the grand
total at both the Semester I Semester II examinations
taken together and grade “A” in the thesis
1 st Class with Distinction
1 st Class
1 st Class.
4 All other cases. IInd Class
A thesis that has been rejected may be resubmitted after due revision and payment of
fresh fee.
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Semester I
SR.NO SUBJECT Exam.
Dur.
1 Analytical
Techniques-I
2 Product
Development
3 Biological
Evaluation
4 Quality
Management-I
5 Computing &
Statistics
Theory Exam. Practical
Int. Ext. Total Dur. Int. Ext. Total
3 20 80 100 6 20 80 100
3 20 80 100 - - - -
3 20 80 100 6 20 80 100
3 20 80 100 - - - -
3 20 80 100 - - - -
Semester- II
SR.NO SUBJECT Exam.
Dur.
1 Analytical
Techniques-II
2 Quality
Management-II
3 Product
Development-II
Theory Exam. Practical
Int. Ext. Total Dur. Int. Ext. Total
3 20 80 100 6 20 80 100
3 20 80 100 - - - -
3 20 80 100 6 20 80 100
4 Packaging 3 20 80 100 - - - -
5 Validation 3 20 80 100 - - - -
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Semester-III
SR.NO SUBJECT Exam.
Dur.
1 Spectral
workshop
2 Project and
Dissertation
work.
Theory Exam. Practical
Int. Ext. Total Dur. Int. Ext. Total
- - - - - - - -
GRADE
RULES FOR REFUND OF FEES FOR M.PHARM. COURSE.
AS PER GOVERNMENT DIRECTIVES
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Analytical Techniques-I
1. UV spectrophotometry (3)
2. Spectofluorimetry (5)
3. Absorption and Emission spectroscopy (4)
4. IR Spectrometry (9)
5. ORD & CD (4)
6. Phase Solubility Analysis (1)
7. Termal Analysis (3)
8. X-Ray diffraction Analysis (2)
9. Water determination (2)
10. Radiochemical method of Analysis and (5)
QC of Radio-pharmaceuticals
Analytical Techniques – I (Practicals) 150 hours
Experiments involving the use of :
1) UV
2) Spectrofluorometer,
3) Flame photometer,
4) Atomic Absorption,
5) IR Spectrometer
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PRODUCT DEVELOPMET-I
1. Preformulation Studies: pka and solubility, kinetic pH profile, partition
coefficient, crystal morphology, polymorphism, powder flow, surface
characteristics, dissolution, compatibility studies, protocol for performulation
studies.
2. Solubilion Techniques: Determination of solubility, solubility
parameters, methods of solubilization including addition of cosolvent, surface
active agents, complexation, dielectric constant, hydrotrophy, chemical
modification.
3. Drug stability: solution stability, solid state stability, parameters for
physical stability testing, programme, Acceterated studies and shelf life
assignment.
4. Tablets Technology: Formulation, manufacturing and evaluation with
special emphasis to unit processes involved including mixing, drying, size
reduction, granulation technology granulation technology, compression and
compression cooling.
5. Coating of solid dosage form: Aqueous and non-aqueous film coating,
polymers, process controls, coating equipments, coating pans, Accela cota, Hicoater,
Driacoater, fluid bed coating equipment e.g. Glatt & Kugel coating
application and metering equipment, particle coating methods, pelletistion.
6. Capsulation Technology: Gelatin-Physical and chemical properties,
additives, substitutes, manufacture of hard gelatin capsules, printing machinery
and operation involved, filling of powders, semisolids and liquids in capsules.
7. Liquid Dosage forms: Formulation, stabilization and evaluation of liquid
dosage forms including suspensions and emulsions, Processing and equipments
used in manufacture.
8. Parenteral Technology: Formulation, stabilization and manufacture of
small and large volume parenterals, stabilization, evaluation and quality control,
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environmental controls and design considerations for parenteral production
facility, freeze drying.
9. Pharmacokinetic Modelling : Two compartment model for IV and
extravascular administration multiple dosing regiments, statistical moment
analysis.
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BIOLOGICAL EVALUATIO
1. Microbiological limit tests. (1)
2. Sterility tests : Methodology & Interpretation (2)
3. Tests for effectiveness of antimicrobial preservatives. (2)
4. Preclinical Drug Evaluation acute (LD50),
Subacute & chronic toxicity, Evaluation of a
Compound for its biological activity, and ED 50
determination, special toxicity tests like teratogenecity
and mutagenecity, clinical trials
5. Biological standaridisation : General principles, scope (8)
and limitations of bioassay, Bioassays of some officical drugs
6. Radioimmunoassay: General principles, scope and limitation. (2)
Radioimmunoassay of some drugs like insulin, digitalls etc.
7. Pyrogens-Production, chemistry and properties of bacterial (2)
pyrogens and endotoxins, Mechanism of action of pyrogens,
Pharmaceuticals aspects, Pyrogen test of IP compared to that of BP & USP,
Interpretation of data, comparison of LAL and official pyrogen tests. (6)
PRODUCT DEVELOPMET
1. Preformulation studies : general considerations.
2. Stability : accelerated studies; shelf-life assignment
3. Animal studies
4. Drug approval
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QUALITY MAAGEMET I
1. Concept of Total Quality Management, Philosophy of GMP’S and GLPS,
ISO9000.
2. Organisation and personnel, responsibilities, training hygene, personnel
records.
3. Premises : Location, design, plant layout, construction, maintenance of
sterilite areas, control of contamination.
4. Equipment, selection, purchase specifications, maintenance clean in place
and sterilize in place.
5. Raw materials; purchase specifications, stores selection of vendors,
controls on raw materials.
6. Manufacture of and controls on various dosage forms, Manufacturing
documents, Master Formula, Batch formula records, Standard Operation
Procedure, Quality audits of manufacturing processes and facilities.
7. In process quality controls on various dosage forms sterile and nonsterile.
Standard Operation Producers for various operation like cleaning, filling,
drying compression, coating, disinfection, fumigation, sterilization,
membrane filteration etc.
8. Packaging and labeling controls, line clearance and other packaging
material.
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COMPUTIG & STATISTICS
PART I
1. Application of computers in pharmaceutical sciences, Stores
Management and inventory control.
2. Data processing : Systems analysis, development and creation of
databse useful in pharmacy practice.
3. Writing programmes in Basic for pharmaceutical calculations.
4. Information acquisition and retrieval systems, abstracting services,
Drug Information Systems, Hospital Information Systems.
5. Statistics in Computing : Statistical data anlaysis, Quality Control
charts using computers.
6. Use of application software like Harvard graphics, Nonllin, Windows
etc.
7. Introduction to expert systems : Medical diagnosis aid systems.
8. Computer modeling and simulation : Application in drug design and
Quantitative Structure Activity Relationships.
PART 2
1. Probability and exectations, standard error of mean, confidence limits,
hypothesis testing, T-Test, chi square test, analysis of variance, F-Test,
standard error of estimates, least squares method. Correlation and
regression coefficients. Coefficient of determination. Prediction of X.
2. Application of statistics in pharmaceutical technology, statistical
quality control and control of analytical methods.
3. Biostatics and statistics in clinical research.
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M.Pharm. SEM II
AALYTICAL TECHIQUES-II
1. Chromatography:
(a) TLC (B) Paper (c) GC (d) HPLC (e) HPTLC
(f) Size exclusion Chromatography (g) Ion-pair chromatography
2. ‘H’ & 13C NMR Spectrometry
3. Mass Spectrometry
AALYTICAL TECHICS – II (PRACTICALS)
Experiments involving the use of :
1. TLC
2. GC
3. HPLC
4. HPTLC
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PACKAGIG DEVELOPMET
1. Glass containers for Pharmaceuticals: Glass types, their manufacture, chemical
performance, testing and quality control.
2. Plastics containers for pharmaceuticals : Classification of plastics, plastic
polymers and their physico-chemical, mechanical and biological properties;
Additives and fabrication processes. Plastic container for parentrals and
transfusion sterile drip kits. Quality control testing and biological toxicity.
3. Paper and paper board : Types of paper, folding cartons, quality control testing
of paper and paper board.
4. Metal containers: Aluminium and timplate, Drums, collapsible tubes and
Aerosol containers, Lacquering, coating and lining.
5. Caps and Closures : Types caps closure liners, childresistant caps. Elastomeric
closures for parenterals, classification of elastomers, physical, chemical and
biological properties and their quality control.
6. Labels and labeling : Types of labels, adhesives, inject and barcoding.
7. Flexible packaging : Types of films, Co-extruded films, foils, coating and
laminates, shrink and stretch films.
8. Corrugated and solid fibre boards and boxes : Type of corrugation methods.
9. Tranist worthiness of package.
10. Packaging Machinery Including strip packaging, form, fill and seal machines,
liquid and solid filling machines, capping machines.
11. Product-Package compatibility,: stability of product, packaging selection and
development criteri.
12.Tamper evident packaging systems.
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VALIDATIO
1. Qualification, Validation and calibration of equipment.
2. Validation of process like mixing, granulation, drying, compression
filtration filling etc.
3. Validation of sterilization methods and equipment, Dry heat sterilization,
Autoclaving, membrane filteration.
4. Validation and audits of analytical procedures.
5. Validation and personnel.
6. Validation of air handling equipment in sterile and non-sterile areas.
7. Validation of water supply system, dematerialized, distilled water for
injection.
8. Validation and security measures for electronic data processing.
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QUALITY MAAGEMET-II
1. Quality control laboratory responsibilities, good laboratory practices,
routine controls, instruments, sampling plans, standard test producers,
non-clinical testing, controls on animal house, Data generation and
storage, Quality control
Documentation, retention samples, records, Audits of quality control
facilities.
2. Finished product release, Quality review, Quality audit. Batch release
documents.
3. Warehousing, good warehousing practices materials management.
4. Distribution and distribution records. Handling of returned goods.
Recovered materials and reprocessing.
5. Complaints and recalls, evaluation of complaints, recall procedures,
related records and documents.
6. Waste disposal, scrap disposal producers and records.
7. Regulatory aspects of pharmaceutical and bulk drug manufacture.
Regulatory drug analysis.
8. Loan license (contract manufacture) audits of.
9. Recent amendmends to Drugs and Cosmetics Act and other relevant
rules. Consumer protection Environmental Protection Act, Certification
and licensing procedures.
10. WHO certification, Globalization of drug industry. Introduction to export
of drugs and import policy.
11. Present status and scope of pharmaceutical industry in India.
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PRODUCT DEVELOPMET—II
1. Dissolution Technology: Dissolution testing devices viz forced
convection, non sink and sink devices, continuous flow through
methods, effect of environmental factors during dissolution testing,
dissolution rate test apparatus for suspensions, topical and transdermal
products, suppositories and controlled release products, in-vitro-In-vivo
correlations.
2. Concepts and systems design for rate controlled delivery : Rate
preprogrammed, activation modulated and feed back regulated drug
delivery system,
3. Oral Drug Delivery Systems : O smotic pressure controlled, membrane
permeationv controlled pH controlled, Ion-exchange controlled, gel
diffusion controlled and hydro dynamically.
Balanced systems, modulation of gastro intestinal transit time.
4. Mucosal drug delivery systems : Mechanism of transmucosal
permeation and mucosal membrane models, Buccal, Nasal, pulmonary,
rectal and vaginal drug delivery systems, delivery of peptide based
pharmaceutical.
5. Ocular delivery of drug : Ocular delivery of drugs, development of
ocular controlled release therapeutic systems.
6. Transdermal drug delivery: Premeation through skin, permeation
enhancers, gel, technologies for developing transdermal drug delivery,
systems and evaluation there of.
7. Parenteral drug delivery systems: Injectable controlled released
formulations, long acting contraceptive formulations, implantable drug
delivery.
8. Intrauterine drug delivery systems: Medicated IUDS, copper IUD,
Homone releasing IUD.
9. Site specific drug delivery: Active and passive targeting, monoclonal
antibiodies for drug targeting particulate carrier systems, microphases,
liposomes and nanoparticles.
10. Drug Approval and preparation of documents.
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