15_M. Ph Drugs Regulatory Affairs

MASTER OF PHARMACY M.Pharm-Drug Regulatory Affairs

Goal It is very essential for the pharmacists to have a thorough knowledge and understanding of the regula regulatory tory requireme requirement nt of pharma pharmaceu ceutica ticall indust industry ry.. Studen Students ts will will be trained trained in areas 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 SY!!A"#S 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*

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Pharma(euti(al a ali+atio*

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/uality Ma Ma*ageme*t sy systems

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PAPER - ) Curre*t Goo+ Ma*ufa(turi*g Pra(ti(es ,(GMP a*+ Do(ume*tatio* Goals %o impart in depth study of good manufacturing practices in an industrial set up including drug laws drug discovery and development process Theory 1.

75 HOURS

cGMP of Pharmaceutical manufacturing ) *volution and Principles of cGMP Schedule+M ,'-+GMP requirements *uropean nion /*0 and nited

12 Hrs 34 Mar5s

States 1ood and !rug $dministration /S1!$0 guidelines on Pharmaceutical manufacturing. 3.

-rgani2ation and personnel responsibilities training hygiene and personal records drug industry location design construction and plant lay out

14 Hrs 34 Mar5s

maintenance sanitation environmental control utilities and maintenance of sterile areas control of contamination and Good ,arehousing Practice. 6.

Packaging of !osage 1orms3 cGMP complied packaging and documentation "abeling requirements of various regulated and non+regulated markets for

47 Hrs 14 Mar5s

%ablets Capsules "iquid -rals Parenterals4 In5ectables and Semisolids. 8.

*quipments selection 6 purchase specifications maintenance clean in place  purchase specifications and maintenance of stores for raw materials.

2.

In process quality control and finished products quality control for following formulation in Pharma industry3 tablets capsules ointments suppositories

47 Hrs 14 Mar5s

14 Hrs 14 Mar5s

creams parenterals ophthalmic and surgical products. 7.

!ocumentation in pharmaceutical industry3 7atch 1ormula #ecord Master 1ormula #ecord !istribution records. Common %echnical !ocument and !rug

14 Hrs 14 Mar5s

Master 1iles. Medical !evices *lectronic Common %echnical !ocumentation 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. RECOMME
8.

Good Manufacturing Practice #ationale and compliance by Aohn Sharp

@. Pharmaceutical master validation plan3 %he ultimate guide to 1!$ GMP and G"P Compliance by Syed Imitia2 'aider  B. Pharmaceutical dosage forms3 Parenterals ol+@ II *dition by Denneth *$ and "eon "achman :.

Packaging and Pharmaceuticals and health care products by '. "ockhart 1rank $. Paine

<. %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. 7liesner.

?.

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# !# etc.0 :. !a&eli*g comparison between brand 6 generics. /#eview of Promotion Materials0

PAPER - )) Pharma(euti(al ali+atio*

+

Goals 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(. THEORY 1.

3.

24 HO#RS

$n Introduction to the 7asic Concepts of Process alidation 6 'ow it !iffers from &ualification /Installation &ualification /I&0 -perational &ualification /-&0 6 Performance &ualification /P&0 Procedures alidation master plan /MP0 $ #eview of Prospective Concurrent #etrospective alidation 6 #evalidation including the use of Statistical Process Control /SPC0

HA

49 Hrs 14 Mar5s



48 Hrs 14 Mar5s

3.8 6.

8.

2.

Planning 6 Managing a alidation Program including Change Control Scale+p and Post+$pproval Changes /SP$C0 Pre $pproval Inspections /P$I0 6 %echnology %ransfer Issues alidation of ,ater /!emineralised !istilled and ,ater for In5ection0 6 %hermal Systems including 'eat entilation and $ir conditioning /'$C0 1acilities 6 Cleaning alidation Process alidation of $ctive Pharmaceutical Ingredients /$PIs0 and finished  products.

4; Hrs 34 Mar5s

46 Hrs 14 Mar5s

49 Hrs 14 Mar5s

!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 7.

34 Mar5s

9.

46 Hrs

Medical !evice In Vitro !iagnostics 6 Packaging alidation Issues

14 Mar5s

;.

International

14 Hrs

Conference on 'armoni2ation /IC'0 and ,orld 'ealth -rgani2ation /,'-0

34 Mar5s

alidation

of

$nalytical

Methods

$utomated

Systems

Guidelines for calibration of equipments alidation of process3 miFing granulation drying compression filtration filling alidation of sterili2ation methods and equipments3 dry heat sterili2ation autoclaving membrane filtration. alidation of analytical procedures alidation of air handling equipments and facilities in sterile and non sterile areas.

J .K

4; Hrs

alidation of Sterile and (on+Sterile 1acility

I

+ 3 +

RECOMME
8. Pharmaceutical Process alidation? 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 . Pharmaceutical &uality $ssurance by Manohar $. Potdhar @nd 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 • alidation of machines 6 analytical instruments used for Pharmaceutical formulations. • Process alidation of various pharmaceutical dosage forms. • alidation of medical devices./ vi2. (ebuli2ers Inhalers Infusion pump Insulin pens0 • Cleaning alidation • $nalytical methods alidation •

PAPER $ ))) /uality Ma*ageme*t systems Goals

"earning the system of quality audit regulatory requirements quality evaluation G"P GCP concepts etc. THEORY

24 HO#RS

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

8.

&uality evaluation and batch release3 Change Control !eviation+/planned and unplanned0 Corrective $ction and Preventive $ction /C$P$0 'andling of non+ conformance endor 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

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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 8; Marks ;> 'rs @; Marks

RECOMME
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 Interscience. 9. %he managers guide to IS- 9;;; Denneth ". $rnold 1ree Press 899:. 8;. 'ow %o Practice G"P Good "aboratory Practice Sharma PP andana 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 ol.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 $uditing for quality and regulatory compliance !onald C. Singer %aylor and 1rancis. @;. Current Good Manufacturing Practices M$ 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 ISrequirements. @. &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 III and III0 for submission to regulatory authorities. <. !ocumentation for audits and inspection of manufacturing facilities. >. #eport preparation of G"P for non+clinical testing

PAPER $ ) Pharma(euti(al Regulatory Re0uireme*ts Goals %o develop competency in product development regulatory requirement for product approval 1!$ regulations and guidelines preclinical and clinical trial regulations and requirements. THEORY 24 HO#RS

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

;= 'rs @; Marks

@8 Code of 1ederal #egulations /C1#0 Part 88 and "IMS /"aboratory information Management System0. 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

trials. >. International legal consideration3 7$ /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.

;='rs 8; Marks

RECOMME. 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 '. Slatko 8B. Preparation and Maintenance of the I(! $pplication in eC%! 1ormat 7y ,illiam D. Sietsema 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 •

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• • • • • •

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.

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Patent challenge 4 non infringement /Para I0 case studies. Preparation of $nnual Product &uality #eview /$P�. 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 'I 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.