g Xp and Cg Xp in Pharmaceutical Industry

115
7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 1/115 GxP and cGxP in Bio/Pharmaceutical Industry Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Department of Pharmaceutics KLE University College of Pharmacy BELGAM ! "#$$%$, Karnata&a, 'ndia E(mai)* +&nanjwade-ahoo.co.in e)) No* $$#%#/0102%$$$ 28 March 2011 1 Department of Pharmaceutics

description

GxP

Transcript of g Xp and Cg Xp in Pharmaceutical Industry

Page 1: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 1/115

GxP and cGxP in Bio/Pharmaceutical

Industry

Prof. Dr. Basavaraj K. Nanjwade M.Pharm., Ph. D

Department of PharmaceuticsKLE University College of Pharmacy

BELGAM ! "#$$%$, Karnata&a, 'ndiaE(mai)* +&nanjwade-ahoo.co.in

e)) No* $$#%#/0102%$$$

28 March 2011 1Department of Pharmaceutics

Page 2: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 2/115

GxP

• The bio/pharmaceutical industry has created its ownlanguage and GxP is one of many acronyms that we alltend to use.

• While this may seem “elementary” to some of you,many people may not now what this means.

• G ! Goodx "#ariable replaced with $anufacturing, %linical,

&aboratory, 'torage, (istribution and )e#iew*P ! Practice

2Department of Pharmaceutics28 March 2011

Page 3: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 3/115

GxP

• +s you can see, GxP is used as shorthand form forreferring to the regulations established by the -nited 'tatesood and (rug +dministration which are published in the%ode of ederal )egulations.

• 'ometimes people refer to the “G%Ps” which specificallyregards the rules that go#ern clinical trials #s. productmanufacturing "G$Ps* or laboratory regulations "G&Ps*.

•   Together, these are nown collecti#ely as the “predicaterules” that go#ern a wide spectrum of regulatory obligationsacross this di#erse industry.

Department of Pharmaceutics28 March 2011

Page 4: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 4/115

GxP

•GxP is also where citations emanate from "typically* asregards (+ inspections.

• When a regulation is cited, the title tells you where it is

published.

or example 21 CFR 312.2

$eans21 = Title 21

CFR = Code o Federal Re!ulations

312.2 "312 = #art and 2 =section$!Department of Pharmaceutics28 March 2011

Page 5: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 5/115

%iecycle Re&uirements

"Department of Pharmaceutics28 March 2011

Page 6: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 6/115

GxP

“GxP” is a collecti#e term for the Good Practice 0ualityguidelines and regulations used in many fields,

encompassing such internationallyrecogni1ed standards

as G$P, G%P, G&P, G'P, G(P and G)P.

• GxP guidelines are designed to ensure that products are

safe, meet their intended use and, in regulated industries

such as drugs, food, medical de#ices and cosmetics,adhere to 0uality processes during manufacturing, control,

storage and distribution.

#Department of Pharmaceutics28 March 2011

Page 7: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 7/115

GxP

GxP  is a general term for Good Practice  0uality guidelines and regulations. These guidelines are used inmany fields, including the pharmaceutical  and foodindustries.

• The titles of these good practice guidelines usually begin with 2Good2 and end in 2Practice2, with the specificpractice descriptor in between.

•  GxP  represents the abbre#iations of these titles, where x   "a common symbol for a #ariable* represents thespecific descriptor.

$Department of Pharmaceutics28 March 2011

Page 8: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 8/115

Core G'P Inormation

8Department of Pharmaceutics28 March 2011

Page 9: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 9/115

  Re!ional (armoni)ation Initiati*es

%Department of Pharmaceutics28 March 2011

Page 10: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 10/115

GxP

10Department of Pharmaceutics28 March 2011

Page 11: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 11/115

%ist o GxP+s in Pharmaceuticals

1. G,P - "Good manuacturin! Practice$

2. GCP - "Good Clinical Practice$

3. G%P - "Good %aoratory Practice$. G0P - "Good 0tora!e Practice$

. GP - "Good istriution #ractice$

. GRP - "Good Re*ie4 Practice$

11Department of Pharmaceutics28 March 2011

Page 12: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 12/115

Pur#ose o GxP

The purpose of the GxP 0uality guidelines is to ensure a productis safe and meets its intended use.

• GxP guides 0uality manufacture in regulated industries includingfood, drugs, medical de#ices and cosmetics.

The most central aspects of GxP are

1. Traceaility5 the ability to reconstruct the de#elopment historyof a drug or medical de#ice.

2. 6ccountaility5 the ability to resol#e who has contributed whatto the de#elopment and when.

12Department of Pharmaceutics28 March 2011

Page 13: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 13/115

Re!ulators

1Department of Pharmaceutics28 March 2011

Page 14: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 14/115

G,P - "Good ,anuacturin! Practice$

28 March 2011 Department of Pharmaceutics 1!

Page 15: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 15/115

3hat is GMP 4

• G$P is that part of 3uality assurance which ensures that

the products are consistently manufactured and controlled

to the 3uality standards appropriate to their intended use

• + set of principles and procedures which, when followed by

manufacturers for therapeutic goods, helps ensure that the

products manufacture will ha#e the re0uired 0uality.

28 March 2011 Department of Pharmaceutics 1"

G d M f t i

Page 16: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 16/115

Good Manufacturin5Practices

+ basic tenet of G$P is that 0uality cannot be tested into abatch of product but must be built into each batch of product

during all stages of the manufacturing process.

• 4t is designed to minimi1e the riss in#ol#ed in any

pharmaceutical production that cannot be eliminated through

testing the final product. 0ome o the main ris7s are unex#ected contamination o #roducts8 causin! dama!e to

health or e*en death

In correct laels on containers8 4hich could mean that #atient recei*e the 4ron!

medicine.

Insuicient or too much acti*e in!redient8 resultin! in ineecti*e treatment or ad*erse

eects.

28 March 2011 Department of Pharmaceutics 1#

Page 17: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 17/115

GMP

28 March 2011 Department of Pharmaceutics 1$

&C

'MP

&(

Page 18: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 18/115

GMP

• 'MP is the magic )ey that opens the*oor of the &uality

• +n matter of 'MP, s-im -ith thecurrent an*

in matter of &uality stan* li)e aroc).

28 March 2011 Department of Pharmaceutics 18

Page 19: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 19/115

GMP

28 March 2011 Department of Pharmaceutics 1%

'MP

+s that part of &uality

(ssurance aime* atensuring that pro*ucts are

consistently manufacture*

to a /uality appropriate totheir inten*e* use

Page 20: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 20/115

GMP 5uide)ines

• 'MP as per che*ule M

• 'MP as per 345

'MP as per MC( no- )no-n as M46(• 'MP as per 7'(

• 'MP as per U D(

• 'MP as per +C4 gui*elines

28 March 2011 Department of Pharmaceutics 20

Page 21: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 21/115

G,P !uidance documents

• EU Good Manufacturing Practice (GMP)Guidelines, Volume 4 of “The rules governingmedicinal roducts in the Euroean Union! 

• U" #$% current Good Manufacturing Practice(cGMP) for finished harmaceuticals, &' #, &'*and &''

+- Good Manufacturing Practices for harmaceutical roducts, %nnex 4 to +-Technical eort "eries, .o/ 0*1, &**2

21Department of Pharmaceutics28 March 2011

Page 22: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 22/115

GMP

• 'MP in soli* *osage forms

• 'MP in semisoli* *osage forms

'MP in Li/ui* orals• 'MP in Parenterals Pro*uction

• 'MP in (yurve*ic me*icines

'MP in 9io technological pro*ucts• 'MP in :utraceuticals an*

cosmeceuticals

28 March 2011 Department of Pharmaceutics 22

Page 23: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 23/115

6PI ,anuacturin! Process

2Department of Pharmaceutics28 March 2011

0econdary ,anuacturin! osa!e

Page 24: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 24/115

  0econdary ,anuacturin! osa!e

Forms

2!Department of Pharmaceutics28 March 2011

0 d M f t i P

Page 25: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 25/115

  0econdary Manufacturing Process -

Tablets

2"Department of Pharmaceutics28 March 2011

0 d , t i P

Page 26: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 26/115

  0econdary ,anuacturin! Process -

0terile #arenteral or in9ection

2#Department of Pharmaceutics28 March 2011

Page 27: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 27/115

Pac7a!in!

2$Department of Pharmaceutics28 March 2011

Page 28: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 28/115

Pac7a!in!

28Department of Pharmaceutics28 March 2011

Page 29: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 29/115

Pac7a!in!

2%Department of Pharmaceutics28 March 2011

Page 30: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 30/115

Biotechnolo!y ,anuacturin! Process

0Department of Pharmaceutics28 March 2011

Page 31: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 31/115

6en Princip)es of GMP

5. (esign and construct the facilities and e0uipments properly6. ollow written procedures and 4nstructions

7. (ocument wor

8. 9alidate wor

:. $onitor facilities and e0uipment

;. Write step by step operating procedures and wor oninstructions

<. (esign ,de#elop and demonstrate =ob competence

>. Protect against contamination?. %ontrol components and product related processes

5@. %onduct planned and periodic audits

28 March 2011 Department of Pharmaceutics 1

Page 32: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 32/115

Be-ond GMP

)educe pollution  Aero discharge

• +daptation of en#ironment friendly methods

• %onsideration for better and healthier life tomorrow

• %onsideration of ethics in life

• Bne should begin with end in mind otherwise it will be the

beginning of the end28 March 2011 Department of Pharmaceutics 2

Page 33: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 33/115

ost of e7ective GMP

4n fact %ost benefits C positi#e cost benefits of G$P/3+

• Good plant lay out, 'mooth wor flows, Dfficientdocumentation systems, well controlled process, good stores

lay outs and stores records These are Good manufacturingpractices

• )eduction in wor in process and in#entory holding costs

• +#oidance of cost of 3uality failure " cost of waste, of rewor,of recall, of consumer compensation and of loss of companyreputation

28 March 2011 Department of Pharmaceutics

Page 34: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 34/115

ost 8 Bene9t ana)-sis

• 'MP is not an 5n;cost<

• +t is not even =ust free

• +t is a contri>ution to pro?t

• 'oo* manufacturing Practice is also'oo* management Practice lea*ing to'oo* Manufacturing Pro?t

• 'MP is central an* >asic an* has cost>ene?ts @ not to >e consi*ere* aseAtrinsic or impose* upon manufacturingactivitiesB

28 March 2011 Department of Pharmaceutics !

Page 35: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 35/115

ost 8 +ene9t ana)-sis

28 March 2011 Department of Pharmaceutics "

• Cost of /uality Cost of ( Cost of 9; Pay>ac) from C Pro?t

( 9 C

ta crap +mprove* morale

 7raining 6e-or) Motivation

ystems Complaints aster throughput

Documentation Chaos 4igher pro*uctivityE/uipment Lost sales +ncrease* sales

Maintenance 6ecalls lo-er inventory

Cali>ration Close*o-n

ampling

 7esting

+n process control

Fali*ation

(u*iting

Page 36: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 36/115

GCP - "Good Clinical Practice$

28 March 2011 Department of Pharmaceutics #

Page 37: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 37/115

:hat It Is GCP

• 6n international ethical ; scientiic &uality standard or

desi!nin!8 conductin!8 recordin! ; re#ortin! human clinical

studies

 – <

 – >a#an

 – 0

• 6##lies to re!istration studies that may ha*e an im#act on

saety ; 4elare o human su9ects

28 March 2011 Department of Pharmaceutics $

Page 38: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 38/115

GCP Partici#atin! Parties

• IRB/<thics Committee

• In*esti!ators

• 0#onsor

• Re!ulatory 6uthorities

28 March 2011 Department of Pharmaceutics 8

Page 39: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 39/115

GCP ?ey ocuments

• In*esti!ator Brochure

• 0tudy Protocol

• Inormed Consent ocument

28 March 2011 Department of Pharmaceutics %

Page 40: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 40/115

GCP Princi#les

1. 0tudies in accordance 4ith eclaration o (elsin7i@

consistent 4ith GCP ; a##licale re!ulatory

re&uirements

2. 0tudies initiated ; continued only i antici#ated eneitsout4ei!h ris7s

3. Ri!hts8 saety ; 4elare o human su9ects ta7e #riority

o*er interests o science ; society

. 6*ailale nonAclinical ; clinical ino on #roduct ade&uate

to su##ort study

28 March 2011 Department of Pharmaceutics !0

Page 41: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 41/115

GCP Princi#les

. 0tudies scientiically sound@ descried in clear8 detailed#rotocol

. 0tudy in com#liance 4ith IRB/<C a##ro*ed #rotocol

. ,edical care !i*en to su9ects is the res#onsiility o&ualiied medical #roessional"s$

. Indi*iduals conductin! studies &ualiied y education8

trainin! ; ex#erienceD. Freely !i*en inormed consent otained rom e*ery

su9ect #rior to study #artici#ation

28 March 2011 Department of Pharmaceutics !1

Page 42: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 42/115

GCP Princi#les

1E. 0tudy inormation recorded8 handled ; stored to allo4

accurate re#ortin!8 inter#retation ; *eriication

11. Conidentiality o su9ect records #rotected in

accordance 4ith a##licale re!ulatory re&uirements

12. In*esti!ational #roducts manuactured8 handled ; stored

in accordance 4ith GCP ; used in accordance 4ith

a##ro*ed #rotocol

13. 0ystems/#rocedures im#lemented to assure &uality o

study

28 March 2011 Department of Pharmaceutics !2

Page 43: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 43/115

IRB/<C Roles ; Res#onsiilities

To sae!uard study su9ects+ ri!hts ; 4elare y5

• <*aluation/dis#osition o study #ro#osal

<*aluation o #ro#osed su9ect consent materials• <*aluation o emer!ency use consent methodolo!y

• <*aluation o in*esti!ator &ualiications

• n!oin! re*ie4 o study #ro!ress "at least yearly$

• <*aluation o #ro#osed su9ect com#ensation #lans

28 March 2011 Department of Pharmaceutics !

Page 44: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 44/115

  IRB/<C Com#osition ; #erations

• ,emershi# has &ualiications ; ex#erience to e*aluate

science8 medical as#ects ; ethics o #ro#osed study

 – memers

 –

1 memer 4hose #rimary interest in nonscientiic – 1 memer inde#endent o institution or study site

• :ritten 0Ps ; records

• ecisions rendered at announced meetin!s 4ith &uorum in

attendance

28 March 2011 Department of Pharmaceutics !!

Page 45: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 45/115

  IRB/<C Com#osition ; #erations

• nly memers #artici#atin! in re*ie4 should

*ote

In*esti!ator may #ro*ide ino on study8 utshould not e in*ol*ed in re*ie4 or *ote

• Honmemers 4ith ex#ertise in s#ecial areas

may e in*ited to assist 4ith re*ie4 "ut cannot*ote$

28 March 2011 Department of Pharmaceutics !"

Page 46: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 46/115

IRB/<C Procedures

• ocument !rou# memershi# ; &ualiications

• 0chedule meetin!s ; notiy memers

• Conduct initial ; on!oin! re*ie4 o studies

• etermine on!oin! re*ie4 re&uency

• Pro*ide ex#edited re*ie4 o minor study chan!es8 in

accordance 4ith re!ulatory re&uirements

• 0#eciy that no su9ect should e enrolled in study #rior to

IRB/<C a##ro*al

28 March 2011 Department of Pharmaceutics !#

Page 47: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 47/115

IRB/<C Procedures

• 0#eciy that no de*iations rom #rotocol should e initiated

 4ithout #rior IRB/<C a##ro*al

 – <mer!ency situations re&uire immediate notiication o IRB/<C ater the

act

• 0#eciy that In*esti!ator should #rom#tly re#ort5

 – Protocol de*iations

 – Chan!es increasin! su9ect ris7 or study #rocedures

 – 0erious and unex#ected ad*erse e*ents

28 March 2011 Department of Pharmaceutics !$

/ d

Page 48: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 48/115

IRB/<C Procedures

• Hotiy In*esti!ator #rom#tly o5

 – 0tudyArelated decisions

 – Reason or decisions

 – Procedures or a##eal o decisions

28 March 2011 Department of Pharmaceutics !8

/ i d d

Page 49: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 49/115

IRB/<C Re&uired Records

• Rele*ant records maintained 3 yr ater study

com#letion

Records a*ailale or re*ie4 y re!ulatoryauthorities

28 March 2011 Department of Pharmaceutics !%

/ C h i i d

Page 50: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 50/115

IRB/<C :hat is Re*ie4ed

• In*esti!ator Brochure or Re#ort o Prior In*esti!ations

• 0tudy #rotocol ; amendments

• In*esti!ator &ualiications

• Inormed consent documents8 includin! su9ect recruitin!tools

• ther 4ritten inormation #ro*ided to su9ects

• 0u9ect com#ensation #lans

• 6d*erse e*ents

• Protocol de*iations

28 March 2011 Department of Pharmaceutics "0

IRB/<C :h R i

Page 51: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 51/115

IRB/<C :hen Re*ie4s ccur

• Prior to study initiation at site

• 6t least yearly durin! study

• urin! study8 as necessitated y5

 – Chan!es in #rotocol8 consent documents8 etc.

 – Chan!es in study in*esti!ator

 – Re#orts o serious or unantici#ated de*iceArelated ad*erse

e*ents• 6t study com#letion or termination

28 March 2011 Department of Pharmaceutics "1

In*esti!ator Roles ;

Page 52: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 52/115

  In*esti!ator Roles ;Res#onsiilities

• ualiied to conduct study

• (a*e ade&uate resources to conduct study

• Pro*ide medical care to study su9ects

• Re!ular communication 4ith IRB/<C re*ie4in! study

• Com#liance 4ith study #rotocol

• ,aintenance o in*esti!ational #roduct accountaility

•Com#liance 4ith study randomi)ation ; unmas7in!#rocedures

• Pro*ide inormed consent to study su9ects

28 March 2011 Department of Pharmaceutics "2

In*esti!ator Res#onsiilities

Page 53: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 53/115

In*esti!ator Res#onsiilities

6##ro#riate ualiications• Trainin! ; ex#erience demonstrated *ia5

 – ,edical license

 – CJ

 – 0#eciali)ed study trainin!

 – GCP trainin!

• I study res#onsiilities dele!ated8 need a list o &ualiied

#ersons to 4hom res#onsiilities are dele!ated

28 March 2011 Department of Pharmaceutics "

In*esti!ator Res#onsiilities

Page 54: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 54/115

In*esti!ator Res#onsiilities

6de&uate Resources

• 0uitale sta ; !ood methods or 7ee#in! them a##rised

• 0uitale acilities

• 6##ro#riate #atient #o#ulation

 – 6ccess to disease or condition

 – Jolume o #atients 4ith disease or condition

28 March 2011 Department of Pharmaceutics "!

In*esti!ator Res#onsiilities

Page 55: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 55/115

In*esti!ator Res#onsiilitiesRe&uired Records ; Re#orts

• <ssential re!ulatory document ile"s$

 – Protocol ; amendments

 – 6##ro*ed inormed consent documents

 – Product accountaility documentation

 – In*esti!ator &ualiications ; a!reements

 – IRB corres#ondence

 – 0tudy dele!ation list

 – 0u9ect screenin!/enrollment lo!s

 –

0tudy monitorin! re#orts – Caliration/maintenance lo!s

 – ,emos to ile

28 March 2011 Department of Pharmaceutics ""

0#onsor

Page 56: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 56/115

0#onsorRoles ; Res#onsiilities

• 0tudy &uality assurance

• 6##ro#riately &ualiied medical #ersonnel to ad*ise on

study

• tili)ation o &ualiied #ersonnel in study desi!n ;

o#erations

• 0tudy mana!ement8 data handlin! ; record 7ee#in!

• In*esti!ator selection ; trainin!

• einition/allocation o study res#onsiilities

28 March 2011 Department of Pharmaceutics "#

0#onsor

Page 57: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 57/115

0#onsorRoles ; Res#onsiilities

• Facilitation o communications et4een In*esti!ators

• 0tudy com#ensation "in*esti!ators and/or su9ects$ ; inancin!

• Re!ulatory authority notiication/sumission

• Conirmation o IRB/<C re*ie4/a##ro*al

• In*esti!ational #roduct inormation

• In*esti!ational #roduct manuacturin!8 #ac7a!in!8 laelin! ;

codin!• In*esti!ational #roduct su##ly ; handlin!

28 March 2011 Department of Pharmaceutics "$

0#onsor

Page 58: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 58/115

0#onsorRoles ; Res#onsiilities

• Record access

• n!oin! saety e*aluation ; re#ortin!

0erious/unantici#ated ad*erse e*ent re#ortin!• 0tudy monitorin!

• 0tudy noncom#liance #rocedures

• 0tudy termination or sus#ension notiication

• 0tudy re#orts

28 March 2011 Department of Pharmaceutics "8

0#onsor

Page 59: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 59/115

0#onsor

Roles ; Res#onsiilities

• 0#onsor may transer res#onsiilities to CR

 – Transer must e documented in 4ritin!

 – 0#onsor still has ultimate res#onsiility or study &uality and

data inte!rity

28 March 2011 Department of Pharmaceutics "%

0t d P t l C t

Page 60: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 60/115

0tudy Protocol Com#onents

• General administrati*e ino

• Bac7!round

• 0tudy #ur#ose ; o9ecti*es

• 0tudy desi!n

• 0u9ect eli!iility re&uirements

• (o4 su9ects 4ill e treated

• (o4 saety ; eicacy 4ill e assessed

• 0am#le si)e 9ustiication ; statistical analysis methods

28 March 2011 Department of Pharmaceutics #0

0tudy Protocol Com#onents

Page 61: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 61/115

0tudy Protocol Com#onents

• (o4 data 4ill e ca#tured ; maintained

• ,onitorin! #rocedures

• Pro#osed inormed consent document

28 March 2011 Department of Pharmaceutics #1

Inormed Consent ocument

Page 62: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 62/115

Inormed Consent ocumentCom#onents

• 0tatement that study in*ol*es KresearchL ; #roductKex#erimentalL "i a##licale$

• 0tudy #ur#ose

Humer o ex#ected study su9ects to e enrolled• 0tudy treatment"s$ ; #roaility or random assi!nment

• 0tudy exams ; #rocedures or duration o trial

• 0u9ect+s res#onsiilities

• Foreseeale ris7s to su9ect "emryo8 etus8 nursin! inant$

28 March 2011 Department of Pharmaceutics #2

Inormed Consent ocument

Page 63: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 63/115

Inormed Consent ocumentCom#onents

• <x#ected eneits

• 6lternati*es #rocedures or thera#ies ; associated

ris7/eneit

• Com#ensation a*ailale in e*ent o studyArelated in9ury or

sic7ness

• 6ntici#ated #ayments to su9ect or study #artici#ation

• 6ntici#ated ex#enses to su9ect or study #artici#ation

• 0tatement that #artici#ation is *oluntary

28 March 2011 Department of Pharmaceutics #

Inormed Consent ocument

Page 64: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 64/115

o ed Co se t ocu e tCom#onents

• escri#tion o extent to 4hich conidentiality can e

assured

• Commitment to 7ee# su9ect a##rised on ne4 inormation

that may aect su9ect+s 4illin!ness to #artici#ate in study

• Contact ino or &uestions re5 su9ect ri!hts@ trialArelated

ad*erse e*ents

•Circumstances under 4hich su9ect+s #artici#ation may eterminated

28 March 2011 Department of Pharmaceutics #!

In*esti!ator Brochure

Page 65: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 65/115

!:hat It Is

6 com#ilation o clinical ; nonAclinical data on the

#roduct that is rele*ant to the #roduct+s study in

humans

Hecessary or In*esti!ator ; IRB/<C re*ie4 to

assess the ris7s/eneits associated 4ith study

28 March 2011 Department of Pharmaceutics #"

In*esti!ator Brochure

Page 66: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 66/115

!Com#onents

Product ormulation summary

Introduction/ac7!round ino re!ardin! #roduct ;

in*esti!ational #lan

• In*esti!ational #roduct #hysical8 chemical ;

#harmaceutical #ro#erties ; ormulation

• HonAclinical studies

• (uman clinical studies

• 0ummary o data ; !uidance or In*esti!ator

28 March 2011 Department of Pharmaceutics ##

Good Clinical Practice

Page 67: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 67/115

Reerence ocuments ; %in7s

• IC( A <5 Guideline or Good Clinical Practice

• 21 CFR E A Inormed Consent

• 21 CFR A Institutional Re*ie4 Board

htt#5//444.ich.or!/cache/com#o/2A2A1.html• htt#5//444.accessdata.da.!o*/scri#ts/cdrh/cdoc

s/ccr/crsearch.cm28 March 2011 Department of Pharmaceutics #$

Page 68: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 68/115

G%P - "Good %aoratory Practice$

28 March 2011 Department of Pharmaceutics #8

:hat It Is G%P

Page 69: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 69/115

:hat It Is G%P

• escries !ood #ractices or nonAclinical la

studies that su##ort research or mar7etin!

a##ro*als or F6Are!ulated #roducts

28 March 2011 Department of Pharmaceutics #%

G%P General Re&uirements

Page 70: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 70/115

G%P General Re&uirements

• 6##ro#riately &ualiied #ersonnel

• 6de&uate resources

• 6##ro#riate #rocedures or5

 – 0anitation8 health #recautions8 clothin!

 – Test #rotocol de*elo#ment8 test methods

 – ata analysis8 re#ort de*elo#ment

• 6##ro#riately &ualiied study director

• uality assurance unction

28 March 2011 Department of Pharmaceutics $0

G%P Facilities Re&uirements

Page 71: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 71/115

G%P Facilities Re&uirements

• 0uitale si)e8 construction8 se!re!ation

 – 6nimal care

 – 6nimal su##lies

 – Test ; control #roducts maintained in a secure area 

 – #eratin! KsuiteL

 – 0#ecimen ; data stora!e

28 March 2011 Department of Pharmaceutics $1

G%P <&ui#ment Re&uirements

Page 72: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 72/115

G%P <&ui#ment Re&uirements

• 6##ro#riately desi!ned

• 6de&uate thruA#ut ca#acity

6##ro#riately located• Routinely maintained ; calirated

28 March 2011 Department of Pharmaceutics $2

G%P 0tandard #eratin! Procedures

Page 73: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 73/115

  G%P 0tandard #eratin! Procedures

• 6nimal room #re#

• 6nimal care

• Recei#t8 I8 stora!e8 handlin!8 mixin! ; sam#lin! o test

; control articles

• Test system oser*ations

• %a tests

• (andlin! o moriund or dead animals

• Hecro#sy or #ostmortem exams o animals

28 March 2011 Department of Pharmaceutics $

G%P 0tandard #eratin! Procedures

Page 74: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 74/115

  G%P 0tandard #eratin! Procedures

• Collection ; I o s#ecimens

• (isto#atholo!y

• ata handlin!8 stora!e ; retrie*al

• <&ui#ment maintenance ; caliration

•Transer8 #ro#er #lacement ; I o animals

28 March 2011 Department of Pharmaceutics $!

G%P Rea!ents ; 0olutions

Page 75: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 75/115

 G%P Rea!ents ; 0olutions

• 6de&uate laelin!

 – Identity

 – Concentration

 – 0tora!e re&uirements

 – <x#iration date

28 March 2011 Department of Pharmaceutics $"

G%P Test ; Control 6rticles

Page 76: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 76/115

 G%P Test ; Control 6rticles

• 6de&uate characteri)ation

• Pro#er recei#t8 stora!e8 distriution

:hen mixed 4ith a carrier8 ade&uate methods toconirm

 – ,ixture uniormity

 – 6rticle concentration

 – 6rticle staility

28 March 2011 Department of Pharmaceutics $#

G%P 0tudy Im#lementation

Page 77: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 77/115

 G%P 0tudy Im#lementation

• :ritten8 a##ro*ed #rotocol indicatin! test o9ecti*es ;methods

• 0tudy conducted in accordance 4ith #rotocol

• 0tudy monitorin! to conirm #rotocol com#liance

• 6##ro#riate laelin! o s#ecimens y test system8

study8 nature ; collection date

• Records o !ross indin!s rom #ostmortems a*ailale

to #atholo!ist or s#ecimen histo#atholo!y

28 March 2011 Department of Pharmaceutics $$

G%P 0tudy Im#lementation

Page 78: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 78/115

 G%P 0tudy Im#lementation

• 0tandard data ca#ture/recordin! re&uirements

 – %e!iility

 – Permanence

 – 6ccountaility

 – Chan!es

28 March 2011 Department of Pharmaceutics $8

G%P Records ; Re#orts

Page 79: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 79/115

 G%P Records ; Re#orts

• Final re#ort o results

• 0tudy records ; data methodically archi*ed toacilitate ex#edient retrie*al

 –

0tudy documents – Ra4 data 

 – 0#ecimens

 – Protocols

 – 6 ins#ections

 – Personnel trainin! ; &ualiications

 – Caliration ; maintenance records

28 March 2011 Department of Pharmaceutics $%

G%P Records ; Re#orts

Page 80: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 80/115

 G%P Records ; Re#orts

• Records retention "shortest o$5

 – 2 yr ater F6 mar7etin! clearance

 – yr ater data sumitted to F6 in su##ort o mar7etin!

a##lication

 – 2 yr ater 0#onsor decision not to #roceed 4ith

mar7etin! a##lication

 –

:et s#ecimens hold as lon! as *iale

• Records transerale 4ith 4ritten F6 notiication

28 March 2011 Department of Pharmaceutics 80

G%P Facility is&ualiication

Page 81: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 81/115

 G%P Facility is&ualiication

• Grounds or dis&ualiication5

 – Failure to com#ly 4ith re!ulations ;

 – Honcom#liance ad*ersely aects study *alidity ;

 – Pre*ious re!ulatory actions ha*e een unsuccessul in

modiyin! acility o#erations

28 March 2011 Department of Pharmaceutics 81

Page 82: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 82/115

G0P - "Good 0tora!e Practice$

28 March 2011 Department of Pharmaceutics 82

G0P - "Good 0tora!e Practice$

Page 83: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 83/115

G0P "Good 0tora!e Practice$

1. Glossary2. Personnel

3. Premises and acilities

. 0tora!e re&uirements. Returned !oods

. is#atch and trans#ort

. Product recall

8Department of Pharmaceutics28 March 2011

1 Glossary

Page 84: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 84/115

1. Glossary

a. +cti#e pharmaceutical ingredient

b. %ontamination

c. %rosscontaminationd. Dxcipient

e. Dxpiry date

f. &abelling

28 March 2011 Department of Pharmaceutics 8!

1. Glossary

Page 85: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 85/115

1. Glossary

g. Pacaging material

h. Pharmaceutical product

i. Production

 =. )etest date

. 'torage

l. 'upplier

28 March 2011 Department of Pharmaceutics 8"

2. Personnel

Page 86: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 86/115

2. Personnel

• +t each storage site "e.g. that of a manufacturer, distributor, wholesaler, community or hospital pharmacy* there should

be an ade0uate number of 0ualified personnel to achie#e

pharmaceutical 0uality assurance ob=ecti#es.

• Eational regulations on 0ualifications should be followed.

28 March 2011 Department of Pharmaceutics 8#

2. Personnel

Page 87: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 87/115

2. Personnel

• +ll personnel should recei#e proper training in relation togood storage practice, regulations, procedures and safety.

•+ll members of staff should be trained in, and obser#e highle#els of, personal hygiene and sanitation.

Personnel employed in storage areas should wear suitableprotecti#e or woring garments appropriate for the acti#ities

they perform

28 March 2011 Department of Pharmaceutics 8$

3. Premises and acilities

Page 88: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 88/115

3. Premises and acilities

a. 'torage areas

b. 'torage conditions

c. $onitoring of storage conditions

28 March 2011 Department of Pharmaceutics 88

. 0tora!e re&uirements

Page 89: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 89/115

. 0tora!e re&uirements

a. (ocumentation written instructions and records

b. &abeling and containers

c. )eceipt of incoming materials and pharmaceutical

products

d. 'toc rotation and control

28 March 2011 Department of Pharmaceutics 8%

. Returned !oods

Page 90: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 90/115

. Returned !oods

• )eturned goods, including recalled goods, should be

handled in accordance with appro#ed procedures and

records should be maintained.

• +ll returned goods should be placed in 0uarantine and

returned to saleable stoc only after this has beenappro#ed by a nominated, responsible person following a

satisfactory 0uality ree#aluation.

• +ny stoc reissued should be so identified and recorded in

stoc records. Pharmaceuticals returned from patients to

the pharmacy should not be taen bac as stoc, but

should be destroyed.

28 March 2011 Department of Pharmaceutics %0

. is#atch and trans#ort

Page 91: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 91/115

. is#atch and trans#ort

)ecords for dispatch should be retained, stating at least

  F the date of dispatch

  F the customerHs name and address

  F the product description, e.g. name, dosage form and

strength "if appropriate*, batch number and 0uantify

  F the transport and storage conditions.

• +ll records should be readily accessible and a#ailable on

re0uest.

28 March 2011 Department of Pharmaceutics %1

. Product recall

Page 92: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 92/115

. Product recall

• There should be a procedure to recall from themaret, promptly and effecti#ely, pharmaceutical

products and materials nown or suspected to be

defecti#e.

28 March 2011 Department of Pharmaceutics %2

Page 93: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 93/115

GP - "Good istriution #ractice$

28 March 2011 Department of Pharmaceutics %

GP - "Good istriution #ractice$

Page 94: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 94/115

" # $

• G(P go#erns the proper distribution of medicinalproducts for human use and regulates the

mo#ement of products from the manufacturersH

premises "or other central point* to the end user "orother intermediate point*.

%!Department of Pharmaceutics28 March 2011

 GP - "Good istriution #ractice$

Page 95: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 95/115

G "Good st ut o # act ce$

1. Princi#le

2. Personnel

3. ocumentation

. Premises and e&ui#ment. eli*eries to customers

. Returns

. 0el ins#ection. Pro*ision o inormation to ,emer 0tates in relation

to 4holesale acti*ities

28 March 2011 Department of Pharmaceutics %"

1. Princi#le

Page 96: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 96/115

#

• Policy ensures that products released for distribution are ofthe appropriate 0uality.

4n addition to this, the 0uality system should ensure that theright products are deli#ered to the right addressee within a

satisfactory time period.

• + tracing system should enable any faulty product to be

found and there should be an effecti#e recall procedure.

28 March 2011 Department of Pharmaceutics %#

2. Personnel

Page 97: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 97/115

• Ie should fulfil his responsibilities personally.

• Person should be appropriately 0ualified although a degreein Pharmacy is desirable, the 0ualification re0uirements

may be established by the $ember 'tate on whose territory

the wholesaler is located.

28 March 2011 Department of Pharmaceutics %$

2. Personnel

Page 98: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 98/115

• Jey personnel in#ol#ed in the warehousing ofmedicinal products should ha#e the appropriate

ability and experience to guarantee that the products

or materials are properly stored and handled.

• Personnel should be trained in relation to the duties

assigned to them and the training sessionsrecorded.

28 March 2011 Department of Pharmaceutics %8

3 ocumentation

Page 99: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 99/115

3. ocumentation

• +ll documentation should be made a#ailable onre0uest of competent authorities

a. Brders

b. Procedures

c. )ecords

28 March 2011 Department of Pharmaceutics %%

. Premises and e&ui#ment

Page 100: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 100/115

& #

• Premises and e0uipment should be suitable andade0uate to ensure proper conser#ation and

distribution of medicinal products.

a. )eceipt

b. 'torage

28 March 2011 Department of Pharmaceutics 100

. eli*eries to customers

Page 101: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 101/115

• (eli#eries should be made only to other authorised wholesalers or to persons authorised to supply medicinal

products to the public in the $ember 'tate concerned.

• 4n case of emergency, wholesalers should be in a position

to supply immediately the medicinal products that they

regularly supply to the persons entitled to supply the

products to the public.

28 March 2011 Department of Pharmaceutics 101

. eli*eries to customers

Page 102: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 102/115

• $edicinal products should be transported in such a way

that

a$ Their identiication is not lost@

$ They do not contaminate8 and are not contaminated y8

other #roducts or materials@c$ 6de&uate #recautions are ta7en a!ainst s#illa!e8

rea7a!e or thet@

d$ They are secure and not su9ected to unacce#talede!rees o heat8 cold8 li!ht8 moisture or other ad*erse

inluence8 nor to attac7 y microor!anisms or #ests.

28 March 2011 Department of Pharmaceutics 102

. Returns

Page 103: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 103/115

a. )eturns of nondefecti#e medicinal products

b. Dmergency plan and recalls

c. %ounterfeit medicinal products

d. 'pecial pro#isions concerning products classified as

not for sale

28 March 2011 Department of Pharmaceutics 10

. 0el ins#ection

Page 104: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 104/115

#

• elf;inspections shoul* >e con*ucte*%an* recor*e*B in or*er to monitorthe implementation of an*

compliance -ith this gui*eline<

28 March 2011 Department of Pharmaceutics 10!

  . Pro*ision o inormation to ,emer0tates in relation to 4holesale acti*ities

Page 105: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 105/115

0tates in relation to 4holesale acti*ities

• Wholesalers wishing to distribute or distributing medicinalproducts in $ember 'tate"s*.

Where appropriate, the competent authorities of this "these*other $ember 'tate"s* will inform the wholesaler of any

public ser#ice obligation imposed on wholesalers operating

on their territory.

28 March 2011 Department of Pharmaceutics 10"

  Guidance documents deal 4ith GP

Page 106: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 106/115

• +- Good $istri3ution Practice, %nnex to Technical eort

"eries, .o/ 025, &**6

• ealth anada Guidelines for Temerature ontrol of $rug Productsduring "torage and Transortation, &**

• 7rish Medicines 8oard Guide to ontrol and Monitoring of "torageand Transortation Temerature onditions for Medicinal Productsand %ctive "u3stances, &**6

•U"P chater 9'*50: Good "torage and "hiing Practice

• EU Guidelines on Good $istri3ution Practice of Medicinal Productsfor uman Use (04; 62;*2)

10#Department of Pharmaceutics28 March 2011

Page 107: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 107/115

GRP - "Good Re*ie4 Practice$

28 March 2011 Department of Pharmaceutics 10$

GRP - "Good Re*ie4 Practice$

Page 108: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 108/115

+ !ood re*ie4 #ractice "GRP$ is a documented best practice within CDER that discusses any aspect related to

the process, format, content, and/or management of a

product re#iew.

• G)Ps are de#eloped o#er time as superior practices based

on %(D)Hs collecti#e experience to pro#ide consistency to

the o#erall re#iew process of new products.

• G)Ps are de#eloped to impro#e the 0uality of re#iews and

re#iew management.28 March 2011 Department of Pharmaceutics 108

GRP - "Good Re*ie4 Practice$

Page 109: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 109/115

• G)Ps impro#e efficiency, clarity, and transparency of the

re#iew process and re#iew management.

• G)Ps are expected to be adopted by re#iew staff as

standard processes through super#isor mentoring,implementation teams, and formal training when necessary.

• (e#eloping G)Ps is an attempt to identify, collect, enhance,

implement, and adopt may of these best practices as

documented and standardi1ed G)Ps that can be shared

among all re#iew di#ision28 March 2011 Department of Pharmaceutics 10%

GRPs Fundamental Jalues

Page 110: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 110/115

K uality M %onsistent implementation of G)Ps by re#iew

staff will enhance the 0uality of re#iews, the re#iew process,and the resultant regulatory action.

K <iciency M G)Ps will impro#e the efficiency of the re#iewprocess through standardi1ation.

K Clarity M G)Ps support clarity throughout the re#iew

process, including critical re#iew and decision acti#ities that

must be completed before a regulatory decision is made.

28 March 2011 Department of Pharmaceutics 110

GRPs Fundamental Jalues

Page 111: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 111/115

K Trans#arency M (e#eloping and documenting G)Psensures that our re#iew processes are readily a#ailable in

one location #ia the 4nternet "through %(D)Hs Web site* to

sponsors and the public.

K Consistency M Ly offering a consistent approach and only

de#iating from it when appropriate "after super#isory

concurrence*, G)Ps help re#iewers achie#e consistency with their re#iews and pro#ide standard re#iew processes

across di#isions and offices.

28 March 2011 Department of Pharmaceutics 111

Page 112: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 112/115

cGxP

28 March 2011 Department of Pharmaceutics 112

cGxP

Page 113: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 113/115

• + 2c2 or 2%2 is sometimes added to the front of the acroynm.

• The preceding 2c2 stands for 2current.2

• or example, cG$P is an acronym for 2current Good

$anufacturing Practices.2 cG$P is the most well nown

example of a GxP.

• The term GxP is only used in a casual manner, to refer in a

general way to a collection of 0uality guidelines.

11Department of Pharmaceutics28 March 2011

cGxP

Page 114: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 114/115

• :hat does cGxP stand orN

• %urrent Good M Practice "(+ compliance M can

mean $anufacturing, %linical, &aboratory, 'torage,

(istribution, )e#iew Pharmaceutical*

11!Department of Pharmaceutics28 March 2011

Page 115: g Xp and Cg Xp in Pharmaceutical Industry

7/21/2019 g Xp and Cg Xp in Pharmaceutical Industry

http://slidepdf.com/reader/full/g-xp-and-cg-xp-in-pharmaceutical-industry 115/115

Than7 youCell Ho5 EED1D231EEE