MPH 101 (T)COMMON PAPER 1ST SEMESTER

(ALL BRANCHES)

I/II M.PHARMACYADVANCED INSTRUMENTAL METHODS OF ANALYSIS (THEORY)

Unit : 1 : UV.VISIBLE SPECTROSCOPY :Brief review of electromagnetic spectrum and absorption of radiations.

The chromophore concept, absorption law and limitations. Theory of

electronic spectroscopy, absorption by organic molecules, choice of solvent

and solvent effects, modern instrumentation - design and working principle.

Applications of UV-Visible spectroscopy (qualitative and quantitative analysis),

Woodward - Fischer rules for calculating absorption maximum.

Unit : 2 : INFRARED SPECTROPHOTOMETRY ;Introduction, basic principles, vibrational frequency and factors

influencing vibrational frequency, instrumentation and sampling techniques,

interpretation of spectra, applications in Pharmacy. FT-IR-theory and

applications, Attenuated Total Reflectance (ATR).

Unit : 3 : NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY :Fundamental Principles and Theory, Instrumentation, solvents,

chemical shift and factors affecting chemical shift, spin-spin coupling, coupling

constant and factors influencing the value of coupling constant, spin-spin

decoupling, proton exchange reactions, FT-NMR, 2D-NMR, NMDR, NOE,

NOESY, COSY and applications in Pharmacy, interpretation of spectra, C13

NMR-Introduction, Natural abundance, C13 NMR Spectra and its structural

applications.

Unit : 4 : MASS SPECTROSCOPY:Basic principles and instrumentation, ion formation and types,

fragmentation processes and fragmentation pattern, Chemical ionization mass

spectroscopy (CIMS), Field Ionization Mass Spectrometry (FIMS), Fast Atom

Bombardment MS(FAB MS), Matrix Assisted laser desorption/ionization MS

(MALDI-MS), interpretation of spectra and applications in Pharmacy.

Unit : 5 : CHROMATOGRAPHIC TECHNIQUES :a) Classification of chromatographic methods based on mechanism of

separation; paper chromatography, thin layer chromatography, ion exchange

chromatography, column chromatography and affinity chromatography -

techniques and applications.

b) Gas Chromatography : Theory and principle, column operation,

instrumentation, derivatisation methods and applications in Pharmacy.

c) High Performance Liquid Chromatography : Principle,

instrumentation, solvents used, elution techniques, RP-HPLC and applications

in pharmacy.

d) HPTLC : Theory and Principle, instrumentation, elution

techniques and pharmaceutical applications.

Unit : 6 : X-RAY DIFFRACTION AND DSC, DTA METHODS :Introduction, Generation of X-Rays, Elementary crystallography; miller Indices,

X-ray, diffraction Bragg’s law, X-ray powder diffraction, X-ray powder

diffractometer, obtaining and interpretation of X-ray powder diffraction data.

Applications of XRD, DSC and DTA in the characterization of Pharmaceutical

solids.

Unit : 7 : STATISTICAL ANALYSIS :Introduction, significance of statistical methods, normal distribution,

probability, degree of freedom, standard deviation, correlation, variance,

accuracy, precision, classification of errors, reliability of results,

confidence interval. Test for statistical significance - students T-test, F-

test, Chi-square test, correlation and regression.

MPH 102 (P)

I/II M.PHARMACY (1st SEMESTER)ADVANCED INSTRUMENTAL METHODS OF ANALYSIS (PRACTICALS)

01. Determination of Isobestic point using bromocresol green.02. Estimation of ranitidine hydro chloride in pharmaceutical formulation

by PDAB reagent.03. Estimation of aceclofenac in pharmaceutical formulation by FC

reagent.04. Estimation of ciprofloxacine in pharmaceutical formulation by ferric.05. Estimation of sulphamethoxazole in pharmaceutical formulation by BM

reagent.06. Estimation of paracetamol (or) gatifloxacine (or) frusemide in

pharmaceutical formulation by UV spectroscopy.07. Simultaneous estimation of amoxicillin & dicloxacillin (or) paracetamol

& nimesulide in pharmaceutical formulation by UV spectroscopy.08. Estimation of Vit B1 & metformin (or) atorvastatin & ezetimib in

pharmaceutical formulation by absorbance ratio method.09. Estimation of paracetamol & diclofenac (or) ornidazole & ofloxacine in

pharmaceutical formulation by derivative spectroscopy.10. Estimation of moisture content by KFR11. Estimation of sodium ions by flame photometer.12. Estimation of potassium ionsby flame photometer13. Estimation of paracetamol (or) aspirin (or) nimesulide in

pharmaceutical formulation by HPLC.14. Simultaneous estimation of paracetamol & nimesulide in

pharmaceutical formulation by HPLC.15. Estimation of paracetamol in pharmaceutical formulation by using

caffeine as internal standard by HPLC.16. Characterization of pharmaceutical solids by using recorded data

of XRD and DSC.

17. Prediction of -max for different organic compounds by usingwoodward fischer rule.

18. Interpretation of IR spectra’s for different organic compounds.19. Interpretation of NMR spectra’s for different organic compounds.20. Interpretation of MASS spectra’s for different organic compounds.

ADVANCED INSTRUMENTAL METHODS OF ANALYSIS

REFERENCE BOOKS :01. Spectrometric identification of Organic Compounds,

Robert, M.Silverstein et al, 7th edition, 1981.

02. Fundamentals of Mathematical Statistics, S.C.Gupta and V.K.Kapoor.

03. Principles of Instrumental Analysis by Donglas A.Skoog, James, J.Leary,

4th Edition.

04. Pharmaceutical Analysis - Modern Methods - Part A, Part B, James W.

Munson - 2001.

05. Vogel’s Text Book of Quantitative Chemical Analysis, 6th Edition, 2004.

06. Chromatographic Analysis of Pharmaceuticals, John A.Adamovics, 2nd

Edition.

07. Practical Pharmaceutical Chemistry, Part two, A.H.Beckett

& J.B.Stenlake - 4th Edition.

08. Instrumental Methods of Chemical Analysis - B.K.Sharma - 9th

Edition.

09. Instrumental Methods ofAnalysis - Hobert H.Willard, 7th Edition.

10. Organic Spectroscopy - William Kemp, 3rd Edition.

11. Techniques and Practice of Chromatography - Raymond P.W.Scott,

Vol. 70.

12. Identification of Drugs and Pharmaceutical Formulations by Thin Layer

Chromatography - P.D.Sethi, Dilip Charegaonkar, 2nd Edition.

13. HPTLC-Quantitative Analysis of Pharmaceutical Formulations -

P.D.Sethi,

14. Liquid Chromatography - Mass Spectrometry, W.M.A.Niessen, J.Van

Der Greef, Vol. 58.

15. Stereo Chemistry - Conformation and Mechanism by P.S.Kalsi,

2nd Edition.

16. Spectroscopy of Organic Compounds by P.S.Kalsi.17. Organic Chemistry by I.L.Finar Vol. II - 5th Edition.

MPH 901 (T)

I/II M.PHARMACY (1st Semester)

QUALITY CONTROL AND QUALITY ASSURANCE (THEORY)

Analysis of Pharmaceutical Dosage form monographs as mentioned invarious pharmacopoeias (I.P., B.P., E.P and U.S.P)

UNIT-1 :

Solid dosage forms (Tablets, Capsules, Powders), Semisolid dosage forms(Ointments, Creams).

UNIT-2 :

Liquid oral preparations (suspensions, gels, emulsions, solutions and elixirs),Eye/Ear and Nasal Drops.

UNIT-3 :

Parenterals (large volume and small volumes), Inhalations (Aerosols,Nebulizers).

UNIT-4 :

Topical preparations, Transdermal drug delivery systems, Novel Drug DeliverySystems.

UNIT-5 :

Sprays, Suppositories, Pessaries, Surgical Dressings.

UNIT-6 :

Quality control of crude drugs : Ash Values, extraction values, Alcohol content,Fiber content .

UNIT-7 :

Reference standards: Source, preparation, characterization, usage, storage andrecords.

MPH 902 (P)

I/II M.PHARMACY (1st SEMESTER)QUALITY CONTROL AND QUALITY ASSURANCE (PRACTICALS)

01 Monographic analysis of Paracetamol tablets as per I.P.

02 Monographic analysis of Aspirin tablets as per I.P.

03 Monographic analysis of Chloramphenicol capsules as per I.P.

04 Monographic analysis of Amoxilline capsules as per I.P.

05 Monographic analysis of Miconazole ointment as per I.P.

06 Monographic analysis of Atropine sulphate ointment as per I.P.

07 Monographic analysis of Clotrimazole cream as per I.P.

08 Monographic analysis of Lignocaine HCl or Diclofenac gel as per I.P.

09 Monographic analysis of Nimesulide suspension as per I.P.

10 Monographic analysis of Cefadroxil oral suspension as per I.P.

11 Monographic analysis of Gentamicine eye drops as per I.P.

12 Monographic analysis of Chloramphenicol eye drops as per I.P.

13 Monographic analysis of Chlorpheniramine maleate injection as per

I.P.

14 Monographic analysis of Diclofenac injection as per I.P.

15 Monographic analysis of Indomethacine suppositories as per I.P.

16 Monographic analysis of Bisacodyl suppositories as per I.P.

17 Quality Control test for Glass Containers.

18 Quality Control test for Caps/Labels.

19 Determination of Ash Values for senna/vasaka/rauwolfia.

20 Determination of water soluble / alcohol soluble/chloroform

soluble/methanol soluble/ Extractive Values for ginger/liquorice/

rauwolfia.

QUALITY CONTROL AND QUALITY ASSURANCE

REFERENCE BOOKS :01. Remington’s Pharmaceutical Sciences - Alfonso and Gennaro

02. Microbiological Assays - Barton J.Wright

03. Pharmaceutical Chemistry - Becket and Stanlake

04. Quantitative Analysis of Drugs in Pharmaceutical

Formulations - P.D.Sethi

05. Pharmaceutical Analysis - Higuchi, Bechmman and Hassan

06. Theory and Practice of Industrial Phamacy - Liebermann and Lachmann07. Indian Pharmacopoeia - 1996.

MPH 903 (P)

I/II M.PHARMACY (1st SEMESTER)BIOLOGICAL STANDARDIZATION (THEORY)

UNIT-1Detailed study of principle and procedures involved in bioassay of:

a) Heparin, insulin, posterior pituitary.

b) Diphtheria, Typhoid.

UNIT-2Principle and procedures involved in biological tests of the following:

a) Living contaminants in vaccines.

b) Endotoxins.

c) Histamine like substances.

d) Toxic elements.

UNIT-3Microbiological assay of:

a) Vitamins e.g. cyanocobalamin.

b) Antibiotics such as Neomycin sulphate.

c) Vaccine e.g. Diphtheria.

UNIT-4a) Biological assay evaluation of oxytocin, rabbies vaccine and

tetanus antitoxinb) Radioimmuno assay: General principles, scope of limitations of

R.I.Ac) Insulin and digitalis, ELISA (instrumentation, principle and

application for analysis of pharmaceuticals)

UNIT-5Detailed study of principle and procedures involved in bio assay of:

a) Radiopharmaceuticals (indium (111In) penetate injection,

ststrontium (89 sr) chloride injection,technetium(99Tc) macrosalib

injection.

b) Estrogens, Hepatitis vaccine, biological assays of Gas-gangreneantitoxin,

UNIT-6Detailed study of principles and procedures involved in bio assay of:

a) Blood and blood related products (anti-blood grouping serum,

human albumin, Human plasma protein fraction, Human

coagulation factors).

b) Biotechnology products (erythropoietin, interferons, streptokinase).

UNIT-7A study of the following as per Indian pharmacopoeia:

a) Test for Pyrogenb) Test for undue Toxicity

BIOLOGICAL STANDARDIZATION

REFERENCE BOOKS :01) Indian pharmacopeia 2007 controller of publications govt. of India,

New Delhi.

02) Bochmman & Hassan, pharmaceutical analysis edited by: Higuchi.

03) D C Garrott, quantitative analysis of drugs.CBS publishers New

Delhi.

04) R V Smith J T Stewart Textbook of biopharmaceutical analysis.

05) Pulok k mukherjee: Quality Control of Herbal drugs ,Business

Horizons pharmaceutical publishers, New Delhi.06) British Pharmacopeia, Department of health U.K.

MPH 108 (T)COMMON PAPER 2nd SEMESTER

(ALL BRANCHES)I/II M.PHARMACY

P DRUG REGULATORY AFFAIRS

UNIT : 1 : PREFORMULATION STUDIES :

a) Introduction to preformulation studies

b) Essential information helpful in designing the preformulation

evaluation of new drug

c) Multidisciplanary development of a drug candidate

d) Principle areas of preformulation research

e) Preformulation studies of solids, liquid, semisolid, sterile dosage

forms, controlled release formulation and occular preparations.

UNIT : 2 : MANUFACTURING :

a) Good manufacturing practice (GMP) guidelines for Active

Pharmaceutical Ingredients (API), Excipients, Finished Products,

Sterile Products, Phase-I Investigational Products as per European

Union, United States and Indian regulatory authorities.

b) Regulatory guidelines for validation of analytical procedures, as

per European Union, United States and Indian regulatory

authorities.

UNIT : 3 : STABILITY AND IMPURITY TESTING :

a) Regulatory requirements as per European Union, United States

and Indian regulatory authorities for stability testing, photo

stability testing for new drugs substances and products including

stability

testing design and evaluation of stability data.

b) Regulatory guidelines for testing of impurities, residual solvents

and metal impurities in drug substances and products.

UNIT : 4 : SPECIFICATIONS, QA & QC :a) Types of specifications. Different test procedures and acceptance

criteria for new drug substances and new drug products as per

regulatory requirements of European Union, United States and

Indian regulatory authorities.

b) Differences between QA & QC

c) Sources of quality variation, control of quality variation, Statistical

Quality Control.

d) Control and assurance of manufacturing practices.

UNIT : 5 : BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES :a) Current guidelines and developments as per regulatory

requirements of European Union, United States and Indian

regulatory authorities in respect of Clinical Bioavailability/

Bioequivalence study design, conduct, documentation, statistical

analysis and reporting.

UNIT : 6 : GOOD CLINICAL PRACTICES (GCP) AND GOOD LABORATORYPRACTICE (GLP)a) Clinical trails : Definition, Clinical trial phases, study design and

statistical analysis of clinical data.

b) International and National Good Clinical Practice Guidelines.

c) International and National Good Laboratory Practice Guidelines.

UNIT : 7 : INTELLUCTUAL PROPERTY RIGHTSa) Introduction to Intelluctual Property (Patents, Copyright,

Trademarks, Trade secretes) etc...

b) Historical development of Intelluctual Property Rights.

c) International regulatory agencies

d) IPR laws and regulations.

e) European Union, United States and Indian patent application

procedures.

DRUG REGULATORY AFFAIRS

REFERENCE BOOKS :01. Websites : http://www.ich.org, http://www.who.int/en/, http://

www.fda.gov/, http://www.ema.europa.eu/ema/, http://

www.cdsco.nic.in/http://www.oecd.org,http://www.uspto.gov/, http:/

www.ipindia.nic.in/http://www.epo.org,http://www.wipo.int/

02. Lachman. The Theory and Practice of Industrial Pharmacy. Latest

edition, Publisher : CBS Publisher & Distributors P Ltd.,

03. Sandy Weinberg. Guideline Book for Drug Regulatory Submissions.

Latest edition. Publisher Wiley

04. Richard A.Gaurino. New Drug approval process (Drugs and

Pharmaceutical Sciences, Vol. 56) Latest edition. Publisher : Marcel

Deckker.

05. Rick.N G. Drugs: From Discovery to Approval. Latest edition, Publisher

: John Willey & Sons.

06. P.Das and Gokul Das. Protection of Intellectual Property Rights. LatestEdition.

MPH 906 (T)

I/II M.PHARMACY (2nd SEMESTER)

ADVANCED PHARMACEUTICAL ANALYTICAL TECHNIQUES(THEORY)

UNIT – I:

Theory, Instrumentation and Applications of the following Special Techniques

in Analysis:

A) Super fluid critical chromatography

B) Gel permeation chromatography

UNIT – II:

Theory, Instrumentation and Applications of the following Special Techniques

in Analysis:

A) Electrophoresis

B) LC-MS, GC-MS

UNIT – III:

A detailed study of the principles, instrumentation and applications of the

following Instrumental Analysis:

A) X-Ray fluorescence spectroscopy

B) Optical rotating dispersion

UNIT – IV:

A detailed study of the principles, instrumentation and applications of the

following Instrumental Analysis:

A) Raman spectroscopy

B) Inductively coupled plasma – atomic emission spectroscopy

C) Electron spin resonance spectroscopy

UNIT – V:

Principles and procedures involved in quantitative determination of various

pharmaceutical dosage forms of

A) Steroids (Dexamethasone and Estrogens)

B) Diuretics (Spiranolactone, Frusemide)

C) Analgesics (Diclofenac, Ibuprofen)

D) Anticancer drugs (Methotrexate, Mercaptopurine)

UNIT – VI:

Microscopy: General aspects, hot stage microscopy, scanning electron

microscopy (SEM), transmission electron microscopy (TEM): Principle,

instrumentation and applications.

Particle size analysis: Zetameter/Zetasizer, photon correlation spectroscopy,

coulter-counter apparatus, atomic force microscopy

UNIT – VII:Principles and procedures involved in Pharmaceutical Analysis by

using the following chromogenic reagents

a) Folin-Ciocalteau reagent (FC reagent)

b) 3-methyl-2-benzothiazolinone hydrazone hydrochloride(MBTH)

c) P-N-Methylamino phenol sulphate (Metol)

d) N-1-Naphthyl ethylenediamine dihydrochloride (Bratton-Marshell agents)

e) P-dimethylaminobenzaldehyde (PDBA) and P-

dimethylaminocinnamaldehyde (PDAC)

f) 1, 2-Naphthaquinone-4-sulfonate sodium (NQS)

g) Ninhydrin reagent

MPH 907 (P)

I/II M.PHARMACY (2nd SEMESTER)

ADVANCED PHARMACEUTICAL ANALYTICAL TECHNIQUES

(PRACTICALS)1. Case studies based on scanning electron microscopy and transmission

electron microscopy

2. Case studies for the determination of particle size by Zetasizer

3. Studies on interpretation of Raman spectra

4. Analysis of proteins/aminoacids by different electrophoretic techniques

5. Estimation of Lamotrigine in Pharmaceutical Formulation by MBTH

Reagent.

6. Estimation of Ezetimibe in Pharmaceutical Formulation by MBTH Reagent.

7. Estimation of Ciprofloxacin in Pharmaceutical Formulation by NQS Reagent.

8. Estimation of Dapsone in Pharmaceutical Formulation by BM Reagent.

9. Identification of amino acids by circular paper chromatography.

10. Estimation of Isoniazide in Pharmaceutical Formulation by TPTZ

Reagent.

11. Estimation of Chloramphenicol in Pharmaceutical Formulation by PDAB

Reagent.

12. Estimation of Ranitidine in Pharmaceutical Formulation by PDAC

Reagent.

13. Estimation of Atorvastatin in Pharmaceutical Formulation by extractive

spectrophotometric method.

14. Estimation of Cetrizine in Pharmaceutical Formulation by extractive

spectrophotometric method.

15. Estimation of Riboflavin in Pharmaceutical Formulation by Colorimetry.

16. Estimation of Quininesulphate in Pharmaceutical Formulation by

Flourimetry.

ADVANCED PHARMACEUTICAL ANALYTICAL TECHNIQUESREFERRENCE BOOKS & JOURNALS :1. Instrumental Methods of Analysis, Willard, Dean and Merrit et al

2. A Text book of pharmaceutical Analysis (Vols. 1 & 2) - Roger E

Schnmor

3. Methods of Drug Analysis - Gaerian & Grbowski

4. A Text Book of Pharmaceutical Analysis - K A Connors

5. Practical Pharmaceutical Chemistry (Vols. 1 & 2) - Beckette &

Stenlake.

6. Pharmaceutical Analysis - P.Parimoo

7. Pharmaceutical Analysis - Kodern Methods by J W Munson (Marcel

Decker)8. Ewing GW. Instrumental methods of chemical analysis, 5th ed., McGraw

Hill Book Company, New York, 1985.

9. Chemical Analysis – Modern Instrumentation Methods and Techniques

by Wiley

10. Skoog, DA, Holler, FJ, Crouch, SR. Principles of instrumental analysis.

6th ed., Baba Barkha Nath printers, Haryana, 2007

11. Silverstein, RM, Webstar, FX. Spectrometric identification of organic

compounds. 6th ed., John Wiley & Sons (Asia) Pvt. Ltd., Singapore, 200512. Gurdeep R. Chatwal, Instrumental Methods of Chemical Analysis,

Himalaya Publishing House, 2006.

13. Whoston C. X-ray methods, John Wiley & Sons, New York, 1987.

14. Indian Drugs (Journal Published by IDMA)

15. Journal of Industrial and Scientific and Inddustrial Research

(Journal Published by CSIR)

16. Journal of Pharmaceutical and Biomedical Analysis

17. Analysis (International Journal)18. Analyst (International Journal)

MPH 908 (T)

I/II M.PHARMACY (2nd SEMESTER)

QUALITY ASSURANCE AND MANAGEMENT (THEORY)UNIT – IBasic Concepts of Quality Assurance: Quality control and quality assurance,

definition, concept, philosophy, concept of total quality management,

functions, sources of variation, change control program.

NABL certification and accreditation procedure, quality audits, EQ (DQ, IQ, OQ

&PQ), process validation (PV) (prospective, retrospective and concurrent).

UNIT – IIGood Laboratory Practices: Scope, Organization, personnel- technical

competence, desirable qualities of analyst, analyst validation, QBD (quality by

design) responsibilities of key personnel in the QC laboratories.Routine

controls, instruments, protocols, non-clinical testing, controls on animal

house, data generation and storage, quality control documents, retention

samples, records, audits of quality control facilities, raw data maintenance.

Complaints and Recalls: Evaluation of complaints, recall procedures, related

records and documents, handling of OOS (out of specification), market

complaint analysis.

UNIT – IIIQuality Control of Cosmeceuticals: Hair care products (shampoo and hair

dyes), baby care products (oils, creams, powders and shampoos), personal

hygiene products (shaving creams, after shave lotions and soaps), eye care

products (eye shadows, eye liners, and eye brow pencils)

UNIT – IVQuality Control of Herbal Products: WHO guidelines for the quality control of

raw materials used in herbal formulations. Quality control of crude drugs:

proximate analysis, including ash and extractive values, crude fiber content,

UV and fluorescence analysis of powdered drugs, quantitative microscopy and

micro-chemical tests. Analysis of official formulations derived from crude drugs

including some herbal preparations, alkaloids (ephedrine, reserpine and

ergotamine).

UNIT – VQuality Control of Nutraceuticals: Vitamins (A, B1, B2, B12, C, D, E and K),

micro nutrients and health supplements including free radical scavengers.

Quality Control of Food Constituents: Carbohydrates, proteins and fats with

special emphasis in the determination of moisture, ash, nitrogen and physical

constituents. General analytical methods for milk and milk constituents (milk

powder and margarine).

UNIT – VIValidation methods of

a) Equipment

b) Processing techniques including mixing, granulation, drying,

compression, filtration and filling.

c) Methods of equipment for dry heat sterilization, autoclaving and

membrane filtration.

d) Air handling equipment and facilities in zones

e) Water supply systems, de ionized and distilled water and water for

injection.

UNIT – VIIA) INSPECTIONS

Pre approval inspections, inspection of pharmaceutical manufactures,

inspection of drug distribution channels, Quality systems requirements for

national good manufacturing practice inspectorates, inspection report,

model certificate of good manufacturing practices.

B) AUDITSGMP compliance audit, Definition summary, audit policy, internal and

external audits, second party audits, external third party audits, preparation

for audit, conducting audit, audit analysis, audit report, audit follow up

MPH 909 (P)

I/II M.PHARMACY (2nd SEMESTER)

QUALITY ASSURANCE AND MANAGEMENT (PRACTICALS)

1. Determination of nitrogen by Kjeldal’s method

2. Estimation of Thiamine by thiochrome method

3. Analysis of hair care products

4. Analysis of eye care products

5. Calibration of UV-VIS spectrophotometer.

6. Calibration of Hot air oven /Auto clave.

7. Calibration of Dissolution /Disintegration test apparatus.

8. Calibration of friability test apparatus /Bulk density test apparatus.

9. Calibration of pH meter / K.F.Titrimeter / Conductivity meter.

10. Calibration of Flame Photometer.

11. Calibration of Nephelometer.

12. Calibration of HPLC (Pump/Injector/Column/Detector).

13. Calibration of Viscometer / Water heating baths / Muffle furnance.

14. Validation of Water supply systems for pharmaceutical use.

15. Validation of Analytical reports / SOP’s /Log books.

16. Purity determination of Analytical reference standards.

17. Process validation of Solid oral dosage forms (Tablets/Capsules).

18. Cleaning validation of Analytical Method for Estimation of Asprin

in Swab/Rinse Samples.

19. Analytical method Validation of Paracetamol by UV-VIS

spectrophotometer.

20. Analytical method Validation of Ciprofloxacin by HPLC.

21. Stability- indicating HPLC method for the determination of

Ascorbic acid in bulk drug and in pharmaceutical dosage forms.

QUALITY ASSURANCE AND MANAGEMENTREFERENCE BOOKS :1. Good laboratory practice: the why and how by Seiler Publisher:

Springer; 2nd edition.2. GMP/ISO Quality Audit Manual for Healthcare Manufactures

and their Suppliers, Volume 2.3. Regulations, standards, and Guidelines, by Leonard Steinborn,

© 2005 by CRC Press, 2000 N.W.Corporate Buld., Boca raton,florida 33431

4. Quality assurance of pharmaceuticals : a compendium of guidelines andrelated materials. Vol. 2, good manufacturing practices and inspection. –2nd ed. © World Health Organization 2007 WHO Press, World HealthOrganization, 20 Avenue Appia, 1211 Geneva 27, Switzerland.

5. Good manufacturing Practices for Pharmaceuticals Sixth editionedited by Joseph D. Nally Nallianco LLC New Vernon, New Jersey, U.S.A.

6. Sharma PP. How to practice GMPs, 4th ed., Vandhana publications Pvt.Ltd., Delhi, 2004.

7. Basic tests for pharmaceutical substances, WHO, Geneva, All Indiatraveler book seller, India, 1990.

8. Harburn K. Quality control of packaging materials in pharmaceuticalindustry. ASQC Quality Press, Milwaukee, 2005.

9. Manual on drugs and cosmetics, 2nd ed., Commercial law publishers(India) Pvt. Ltd., Delhi, 2004.

10. The International Pharmacopoeia, Vol. I-II, 3rd ed., WHO, Geneva, 1981.

11. Maitra K, Ghosh SK. A Guide to total quality management.

12. Mehra ML. Good manufacturing practices (GMP), University BookAgency.

13. Ghosh SK. ISO 9000 and total quality management. Oxford PublishingHouse, Calcutta.

14. Subrahmanyam.CVS, Pharmaceutical Production and Management,2005, Vallabh Prakashan, NewDelhi.

15. Sharma PP. Cosmetics-formulation, manufacturing and quality control.3rd ed., Vandana Publications Pvt. Ltd., Delhi, 2005.

16. Kokare CR. Pharmaceutical microbiology and biotechnology. 2nd ed.,Nirali Prakashan, Pune, 2006.

17. Mukherjee PK. Quality control of herbal drugs: an approach to evaluationof botanicals. Business horizons, New Delhi, 2007.

18. Evans WC. Trease and evans pharmacognosy. 15th ed., Saunders, China.

19. Lachman L, Lieberman HA, Kanig JL. The theory and practice ofindustrial pharmacy, 3rd ed., Varghese Publishers, Bombay, 1991.

20. Remington: The science and practice of pharmacy. 21st ed., vol. I & II,Lippincott Willams & Wilkings, Noida, 2006.

21. Agrawal SS, Paridhavi M. Herbal drug technology. Universities Press(India) Pvt. Ltd., Hyderabad, 2007.

22. Nelson DL, Cox MM. Lehninger principles of biochemistry. 4th ed.,Replika Press Pvt. Ltd., India, 2006.

23. Murray RK, Granner DK, Rodwell VW. Harper’s illustrated biochemistry,27th ed., McGraw-Hill, New Delhi, 2006.

24. David Pearson. The chemical analysis of foods, 7th ed., ChurchillLivingstone, Edinburgh, 1976.