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M.Pharm-Drug Regulatory Affairs

Goal It is very essential for the pharmacists to have a thorough knowledge and understanding of
the regulatory requirement of pharmaceutical industry. Students will be trained in areas of
CGMP !ocumentation drug discovery and development process validation GCP G"P and
quality management system.
#egulatory requirement for drug development product approval pre clinical and clinical trials
and patent laws will be studied in detail.
CGMP !rug laws !rug discovery and development process
Process validation of $PIs and finished products water sterile and non sterile facility
medical devices analytical methods.
Concept of %&M regulatory audits IC' Process G"P GCP
Stability testing
Generic drug development process
(on clinical drug development
Clinical trials
M. Pharm $ Drug Regulatory Affairs
Pa%er Su&'e(t
) Curre*t Goo+ Ma*ufa(turi*g Pra(ti(es ,(GMP-
a*+ Do(ume*tatio*
)) Pharma(euti(al .ali+atio*
))) /uality Ma*ageme*t systems
). Pharma(euti(al Regulatory Re0uireme*ts
Curre*t Goo+ Ma*ufa(turi*g Pra(ti(es ,(GMP- a*+ Do(ume*tatio*
%o impart in depth study of good manufacturing practices in an industrial set up including
drug laws drug discovery and development process
Theory 75 HOURS
cGMP of Pharmaceutical manufacturing ) *volution and Principles of cGMP
Schedule+M ,'-+GMP requirements *uropean .nion /*.0 and .nited
States 1ood and !rug $dministration /.S1!$0 guidelines on Pharmaceutical
12 Hrs
34 Mar5s
3. -rgani2ation and personnel responsibilities training hygiene and personal
records drug industry location design construction and plant lay out
maintenance sanitation environmental control utilities and maintenance of
sterile areas control of contamination and Good ,arehousing Practice.
14 Hrs
34 Mar5s
6. Packaging of !osage 1orms3 cGMP complied packaging and documentation
"abeling requirements of various regulated and non+regulated markets for
%ablets Capsules "iquid -rals Parenterals4 In5ectables and Semisolids.
47 Hrs
14 Mar5s
8. *quipments selection 6 purchase specifications maintenance clean in place
purchase specifications and maintenance of stores for raw materials.
47 Hrs
14 Mar5s
2. In process quality control and finished products quality control for following
formulation in Pharma industry3 tablets capsules ointments suppositories
creams parenterals ophthalmic and surgical products.
14 Hrs
14 Mar5s
7. !ocumentation in pharmaceutical industry3 7atch 1ormula #ecord Master
1ormula #ecord !istribution records. Common %echnical !ocument and !rug
Master 1iles. Medical !evices *lectronic Common %echnical !ocumentation
14 Hrs
14 Mar5s
9. $n introductory study of following laws with regard to drug product design
manufacture and distribution in India /:ith latest ame*+me*ts0 3
a. !rugs and Cosmetics $ct 89:; and its rules 89:<
b. (ational Pharmaceutical Pricing $uthority /(PP$0
c. %he *nvironmental Protection $ct+89=> 6 -ccupational Safety and
'ealth $dministration /-S'$0
d. Consumer Protection $ct+89=>
e. 1actories $ct+89:= and Pollution control $ct+89=9
f. "aw of Contracts /Indian contract $ct+8=?@0
g. Monopolistic 6 #estrictive %rade Practices $ct+89>9
h. "aw of %orts
i. Pharmaceutical inspection convention guide for cGMP
14 Hrs
14 Mar5s
;. !rug discovery and development process3 Principles of !rug discovery and
development. Clinical research process. !evelopment and informational
content for Investigational (ew !rugs $pplication /I(!0 (ew !rug
$pplication /(!$0 handling of -range book $bbreviated (ew !rug
$pplication /$(!$0 Supplemental (ew !rug $pplication /S(!$0 Scale .p
Post approval changes /S.P$C0 and 7ulk active chemical Post approval
4; Hrs
34 Mar5s
changes /7$CP$C0. Post marketing surveillance Current 7iopharmaceutical
regulations and in particular related to Cell %herapy and regenerative medicine.
8. Good Manufacturing Practice #ationale and compliance by Aohn Sharp
@. Pharmaceutical master validation plan3 %he ultimate guide to 1!$ GMP and G"P
Compliance by Syed Imitia2 'aider
B. Pharmaceutical dosage forms3 Parenterals Col+@ II *dition by Denneth *$ and "eon
:. Packaging and Pharmaceuticals and health care products by '. "ockhart 1rank $.
<. %he process of new drug discovery and development. I and II *dition by Charles G.
Smith Aames % and -. !onnell.
>. *stablishing a CGMP laboratory audit system+ $ Practical guide by !avid M.
?. A.1.'anlon3 'and book of package engineering 3Mac+Grawhill company
=. Good manufacturing practices3 $ plan total quality control3 S.'.,ilhing M.M.
%uckerman S.'itchings Marcel !eckker Inc. Eew york.
9. Cell therapy CGMP 1acilities and Manufacturing Springer
PRACT)CA!S ,7 Hours %er :ee5-
T:e*ty Assig*me*ts to &e (arrie+ out a*+ su&mitte+ o* the aforeme*tio*e+ theoreti(al
as%e(ts li5e
8. Do(ume*tatio* for in process and finished products &uality control tests for Solid
Semisolid and Sterile preparations.
@. Proto(ol preparation for purchase of manufacturing equipments and raw materials.
B. Proto(ol preparation for documentation of various types of records / 71# M1# !#
:. !a&eli*g comparison between brand 6 generics. /#eview of Promotion Materials0
PAPER - ))
Pharma(euti(al .ali+atio*
To +e>elo% (om%ete*(y i* i*ter*atio*al gui+eli*es i* the area of >ali+atio* metho+s?
%ro(esses? e0ui%me*ts et(.
1. $n Introduction to the 7asic Concepts of Process Calidation 6 'ow it !iffers
from &ualification /Installation &ualification /I&0 -perational &ualification
/-&0 6 Performance &ualification /P&0 Procedures Calidation master plan
49 Hrs
14 Mar5s
3. $ #eview of Prospective Concurrent #etrospective Calidation 6 #evalidation
including the use of Statistical Process Control /SPC0
48 Hrs
14 Mar5s
6. Planning 6 Managing a Calidation Program including Change Control
Scale+.p and Post+$pproval Changes /S.P$C0 Pre $pproval Inspections /P$I0
6 %echnology %ransfer Issues
4; Hrs
34 Mar5s
8. Calidation of ,ater /!emineralised !istilled and ,ater for In5ection0 6
%hermal Systems including 'eat Centilation and $ir conditioning /'C$C0
1acilities 6 Cleaning Calidation
46 Hrs
14 Mar5s
2. Process Calidation of $ctive Pharmaceutical Ingredients /$PIs0 and finished
!ata generation and storage quality control documents retention samples
records and audits of quality control facilities. 1inished products release quality
review quality audits batch release document
49 Hrs
14 Mar5s
7. Calidation of Sterile and (on+Sterile 1acility
4; Hrs
34 Mar5s
9. Medical !evice In Vitro !iagnostics 6 Packaging Calidation Issues
46 Hrs
14 Mar5s
;. Calidation of $nalytical Methods $utomated Systems International
Conference on 'armoni2ation /IC'0 and ,orld 'ealth -rgani2ation /,'-0
Guidelines for calibration of equipments Calidation of process3 miFing
granulation drying compression filtration filling Calidation of sterili2ation
methods and equipments3 dry heat sterili2ation autoclaving membrane
filtration. Calidation of analytical procedures Calidation of air handling
equipments and facilities in sterile and non sterile areas.
14 Hrs
34 Mar5s
. K
8. Pharmaceutical Process Calidation? Brd *dition *dited by #obert (ash and $lfred
,achter Marcel !ekker
@. Good Manufacturing Practices for Pharmaceuticals3 $ Plan for %otal &uality Control
from Manufacturer to Consumer Sidney A. ,illig Marcel !ekker <th *d.
B. Calidation of Pharmaceutical Processes3 Sterile Products 1rederick A. Carlton /*d.0 and
Aames $galloco /*d.0 Marcel !ekker @nd *d.
:. Calidation Standard -perating Procedures3 $ Step by Step Guide for $chieving
Compliance in the Pharmaceutical Medical !evice and 7iotech Industries Syed Imtia2
<. Pharmaceutical *quipment Calidation3 %he .ltimate &ualification 'andbook Phillip $.
Cloud Interpharm Press
>. Pharmaceutical &uality $ssurance by Manohar $. Potdhar @
edition (irali Prakashan.
PRACT)CA!S ,7 Hours %er :ee5-
T:e*ty Assig*me*ts to &e (arrie+ out a*+ su&mitte+ o* the aforeme*tio*e+ theoreti(al
as%e(ts li5e
Preparation of protocols on various validation requirements
Calidation of machines 6 analytical instruments used for Pharmaceutical formulations.
Process Calidation of various pharmaceutical dosage forms.
Calidation of medical devices./ vi2. (ebuli2ers Inhalers Infusion pump Insulin pens0
Cleaning Calidation
$nalytical methods Calidation

PAPER $ )))
/uality Ma*ageme*t systems
"earning the system of quality audit regulatory requirements quality evaluation G"P GCP
concepts etc.
1. Concept of &uality %otal &uality Management. &uality by design siF sigma concept
;> 'rs
8; Marks
3. $uditors $uditing strategies and preparation of audits &uality audit 6 audit check
lists and $uditing of manufacturing facilities by International regulatory agencies.
Conducting and 'andling of internal4!omestic4International #egulatory $udits4
Customer specific audits 4Pre approval inspections
;? 'rs
8; Marks
6. 'armoni2ation of regulatory requirements+%he International Conference on
'armoni2ation /IC'0 process guidelines to establish quality safety and efficacy of
drug substances and products. Study of IC' common technical documents
harmoni2ation of pharmacopoeial standards %he International -rgani2ation for
Standardi2ation /IS-0 9;;; series of quality systems standards IS- 8:;;;
8; 'rs
@; Marks
&uality evaluation and batch release3 Change Control !eviation+/planned and
unplanned0 Corrective $ction and Preventive $ction /C$P$0 'andling of non+
conformance Cendor evaluation process -ut of specification /--S0 batch
reconciliation and finished goods release Market recalls 6 Market complaints.
;? 'rs
@; Marks
2. Good "aboratory Practices /G"P03 Scope of G"P &uality assurance unit Standard
operating procedures /S-P0 protocols for conduct of non clinical testing control on
animal house report preparation and documentation.
;: 'rs
8; Marks
7. (ational $ccreditation 7oard for testing and Calibration "aboratory /($7"0
certification and accreditation procedure
;B 'rs
8; Marks
9. Stability testing3 IC' and ,'- guidelines Photostability studies
;? 'rs
8; Marks
;. Good Clinical Practices /GCP03 International regulatory requirements for
pharmaceutical development regarding clinical research practices. Current issues in
GCPH standards for design conduct performance monitoring auditing recording
analysis and reporting of clinical trials. Schedule E of Indian !rugs and Cosmetics
$ct 89:; #ole of #egulatory affairs in Product development Clinical phase
Preclinical Phase Manufacturing phase and Marketing Phase. Indian Council of
Medical #esearch /ICM#0 Guidelines for *thics in 7iomedical #esearch.
;> 'rs
@; Marks

8. &uality planning and $nalysis by AM Auran and 1M Gryna %ata McGraw'ill+ India.
@. %otal &uality Management !ale '. 7esterfield Pearson *ducation Brd *d. @;;B.
B. %otal &uality Management Principles Implementation 6 Cases Sharma !.!. Sultan
Chand 6 Sons (ew !elhi @;;;.
:. 1undamentals of %otal &uality Management Process $nalysis and Improvement by
Aens.A !aulgard Dai Driestensen and Gopal D.Dan5i. %aylor and 1rancis
<. %otal &uality Management -rgani2ation and Strategy Aames #. *vans %homson :th
*d. @;;?.
>. &uality Control 7esterfield !.'. Pearson ?th *d. @;;:.
?. Implementing IS- 8:;;;3 a practical comprehensive guide to the IS- 8:;;;
environmental management standards $uthors3 %om %ibor Ira 1eldman *ditors3 %om
%ibor Ira 1eldman Irwin Professional Pub. 899?.
=. *stablishing $ cGMP "abH $udit System+ $ practical guide !avid M.7leisner ,iley
9. %he managerGs guide to IS- 9;;; Denneth ". $rnold 1ree Press 899:.
8;. 'ow %o Practice G"P Good "aboratory Practice Sharma PP Candana Publications
88. G"P *ssentials3 $ Concise Guide to Good "aboratory Practice Second *dition Milton
$. $nderson Informa 'ealthcare.
8@. G"P &uality $udit Manual Milton $. $nderson %hird *dition Informa 'ealthcare.
8B. "aboratory $uditing for &uality and #egulatory Compliance by !onald C.Singer Stefan
and Stedan !rugs and Pharmaceutical Sciences Col.8<;
8:. 'andbook of Stability %esting in Pharmaceutical !evelopment3 #egulations
Methodologies and 7est Practices 'uynh+7a Dim Springer.
8<. International Stability %esting Ma22o A. Ma22o !avid A. Ma22o Informa 'ealthcare
Pharmaceutical Stability %esting %o Support Global Markets /biotechnology3
Pharmaceutical $spects0 Dim 'uynh+ba Springer.
8>. Good "aboratory Practice #egulations %hird *dition #evised and *Fpanded *dited by
Sandy ,einberg
8?. 'andbook of Stability %esting in Pharmaceutical !evelopment3 #egulations
Methodologies and 7est Practices Dim 'uynh+ba Springer.
8=. Good Clinical Practice3 Standard -perating Procedures for Clinical #esearchers ,iley.
89. "aboratory $uditing for quality and regulatory compliance !onald C. Singer %aylor and
@;. Current Good Manufacturing Practices M$ Potdhar 7S Publications.
PRACT)CA!S ,7 Hours %er :ee5-
T:e*ty Assig*me*ts to &e (arrie+ out a*+ su&mitte+ o* the aforeme*tio*e+ theoreti(al
as%e(ts li5e
8. Preparation of S-Ps for various equipments and manufacturing processes as per IS-
@. &uality control tests on Solid liquid semisolid and sterile dosage forms
B. $ccelerated and Photostability studies on dosage forms as per IC' Guidelines
:. Preparation of final clinical trial report /Phase III and III0 for submission to regulatory
<. !ocumentation for audits and inspection of manufacturing facilities.
>. #eport preparation of G"P for non+clinical testing
PAPER $ ).
Pharma(euti(al Regulatory Re0uireme*ts
%o develop competency in product development regulatory requirement for product approval
1!$ regulations and guidelines preclinical and clinical trial regulations and requirements.
8. Generic !rug Product development3 Introduction &uality Control and
&uality $ssurance /&C 6&$0 'atch+,aFman update !rug product
performance+ in vitro, $(!$ #egulatory $pproval Process 7ioequivalence
and !rug Product $ssessment+ in vivo, Scale up Post approval changes Post
marketing surveillance -utsourcing 7ioavailability and 7ioequivalence
studies to Contract #esearch organi2ations. 1ormats for marketing
authori2ation submission to .S *. $sia+P$C /includes countries of *ast
$sia southeast $sia $ustralasia -ceania0 etc. !ata privacy Protection and
Intellectual property patents Pharmaceutical "abeling $dvertising and
Promotion #isk Management in regulatory affairs
8; 'rs
@; Marks
@. #egulatory requirements for product approvals3 $ctive Pharmaceutical
Ingredients 7iologics (ovel therapies special categories L -ver the counter
/-%CS0 herbal medicines and 'omeopathicK obtaining (ew !rug
$pplication /(!$0 $bbreviated (ew !rug $pplication /$(!$0for generic
drugs ways and means of .S #egistration for foreign drugs Chemistry
Manufacturing and controls /CMC0 Post approval #egulatory affairs
#egulation for combination products /Controlled release systems0 medical
device *nvironmental concerns and regulations
@8 Code of 1ederal #egulations /C1#0 Part 88 and "IMS /"aboratory
information Management System0.
;= 'rs
@; Marks
B. 1!$ $pprovable indications and other considerations3 !ata procession for
Global submission %eFt and %abular eFposition+ Common %echnical
!ocument /C%!04 electronic Common %echnical !ocument /eC%!0 1ormat
working with contract #esearch -rgani2ation /C#-0 Industry and 1!$
"iaison #ole of *uropean Commission Competent $uthorities and (otified
7odies and .S1!$ $uthorities
;= 'rs
@; Marks
:. (onclinical drug development3 Global submission of Investigational (ew
!rug application /I(!0 (ew !rug application /(!$0 $bbreviated (ew
!rug $pplication /$(!$0 Investigation medicinal product !ossier /IMP!0
6 Investigator 7rochure /I70 (ew product $pplications for Global
Pharmaceutical Product approvals .S (!$ vs Global C%! 1ormats $(!$
6 Supplemental $bbreviated (ew !rug $pplication /S(!$0 C%! and
eC%! for registration of pharmaceuticals for 'uman use combination
products /Controlled release systems0.
<. Clinical trials3 !eveloping clinical trial protocols Institutional #eview 7oard4
Independent *thics committee+formation and working procedures Informed
consent+process and procedures 'IP$$+ $ new requirement to clinical study
process Code of 1ederal #egulations /C1#04 International Conference on
'armoni2ation /IC'04*. GCP obligations of Investigators sponsors 6
Monitors Importance of &uality $ssurance in clinical trials Managing and
Monitoring clinical trials *uropean clinical trials /C%0 directives+
implementation and update. Pharmacovigilance+safety monitoring in clinical
;= 'rs
@; Marks
;= 'rs
8; Marks
>. International legal consideration3 7M$ /7ureau of eFport administration0
*$# /*Fport administration regulation0 *CC( /*Fport control classification
number0 S%*"$ /System for tracking eFport license application0 1CP$
/1ederal corrupt practice act0 *P$ /*nvironmental protection agency
regulation0 S1! /Securities 6 eFchange commission0.
8; Marks
8. Generic !rug Product !evelopment Solid -ral !osage forms "eon Shargel and Isader
Daufer Marcel !ekker series Col.8:B
@. %he Pharmaceutical #egulatory Process *dited by Ira #. 7erry Marcel !ekker
B. %he Pharmaceutical #egulatory Process Second *dition *dited by Ira #. 7erry and
#obert P. Martin !rugs and the Pharmaceutical SciencesCol.8=<
Informa 'ealth care Publishers.
:. (ew !rug $pproval Process3 $ccelerating Global #egistrations 7y #ichard $ Guarino
M! <
edition !rugs and the Pharmaceutical Sciences Col.89;.
<. Guidebook for drug regulatory submissions 4 Sandy ,einberg. 7y Aohn ,iley 6 Sons.
>. 1!$ regulatory affairs 3 a guide for prescription drugs medical devices and biologics
4edited by !ouglas A. Pisano !avid Mantus.
?. Clinical %rials and 'uman #esearch3 $ Practical Guide to #egulatory Compliance 7y
1ay $. #o2ovsky and #odney D. $dams
=. 'IP$$ and 'uman Sub5ects #esearch3 $ &uestion and $nswer #eference Guide 7y
Mark 7arnes A! ""M and Aennifer Dulynych A! Ph!
9. Principles and Practices of Clinical #esearch Second *dition *dited by Aohn I. Gallin
and 1rederick P. -gnibene
8;. !rugs3 1rom !iscovery to $pproval Second *dition 7y #ick (g
88. (ew !rug !evelopment3 $ #egulatory -verview *ighth *dition 7y Mark Mathieu
8@. Pharmaceutical #isk Management 7y Aeffrey *. 1etterman ,ayne ". Pines and Gary '.
8B. Preparation and Maintenance of the I(! $pplication in eC%! 1ormat 7y ,illiam D.
8:. Medical !evice !evelopment3 $ #egulatory -verview 7y Aonathan S. Dahan
8<. Medical Product #egulatory $ffairs3 Pharmaceuticals !iagnostics Medical !evices7y
Aohn A. %obin and Gary ,alsh
PRACT)CA!S ,7 Hours %er :ee5-
T:e*ty Assig*me*ts to &e (arrie+ out a*+ su&mitte+ o* the aforeme*tio*e+ theoreti(al
as%e(ts li5e
Preparation of regulatory compliance checklist tabulating cGMP requirements as per @8
C1# @8; and @88.
Preparation of global list of documents for registration of I(! (!$ $(!$ as per IC'
C%! format.
Preparation of $nnual report for regulatory on approved $(!$
Case studies on response with scientific rationale to .S1!$ ,arning "etter
Preparation of an IMP! for *. submission.
Preparation of a Clinical %rial Protocol for submission to #egulatory.
Preparation of regulatory compliance requirements for 7$47* study.
Preparation and documentation for Indian Patent.
Patent challenge 4 non infringement /Para IC0 case studies.
Preparation of $nnual Product &uality #eview /$P&#0.
Preparation of Periodic Safety .pdate #eport /PS.#0.
Comparison of key GMP requirements of India .S *. and Aapan of a dosage form.
Comparison of Clinical %rial $pplication #equirements of India .S *. and Aapan of a
dosage form.
1ast track approval in different countries considering different class of drugs /e.g. $nti
'IC and anticancer0 therapeutic area /rare diseases0 etc.
$nnotated side by side comparison of labels Prescribing Information and Patient
Information "eaflet.
Preparation of generic product registration application as per $ssociation of South *ast
$sian (ations L$S*$(K C%! /$C%!0
Preparation of a marketing authori2ation application for -%C homeopathic and 'erbal
Medicinal Product.