SAKTHI P

ROLL ND: l028

BASIC PHARMACEVTICAL
ScIENCE AssIGNMENT-2
2Yec Bsc. BiOTECHNoLOy
 C0OD MANUFACTURING PRACTICE
Crocd Hanufectuing Prnchce MP) is a Set

and gidelfnes on te
e Yequlations, codes
Mectcal
maactuvng e e diugs pwdcts,
Cund
Cund in vwo di
aq nostie
produt
i n vito
devi ws,
System eusaiug that
radcos LE is a

ad Cowtrelled
poduchs a Covnslsteny prduced
AtLedingtvuaut SFandrmds. Tt s desigwd
înwolwel in ay PhoumaCedhe
t6 minimie t a isk

produdo
Prodndto hat Cannet be elimimnated Haoug
ten prodncks

GIcod Mannlacfwn prach tht peut oj

Cyne y osuma hich e nsues thaprcduts au

Conballed to te emoality
Conistemy predued omd

Sandls appsopiale to uteudod we and

Yeend by
|Teennd
mrketing autthazation
 GMP amed imaily at diminshinea t

sks tvdhoret in phonme Cehical poomchen .

Snc isle a esnia two e

amd m Mu lausd b
ess Co/tamunabion
Contounay.
exaple, aseJables be n put on

Ander aMPs
au clarl dyid
mamlactuing pivusse

9ysremakea eviemad n tt h t experiena

eviewed

tbe Capble CovnsistenRy

vnd
vnd Shown
te reapu
manyactiuy pheAmnCeuubiea preduch ef

Htn Specplekes
wakyhat comp wit
ualifcahen amd Validabieu peyoel

reomte an povided, incuding

Appropriately ained ad qualiptd personel

Adauat premúses and Space

Siubble enuipmeut and Sevite

Apjpepriate Makeuals Containau a Jabls

pproved Proceduus aud nshuetons

 aud Fraspet
Sui table s o
ldauat pevonnal tabvataes

lonrds
eapmeat Jo in-pTotes
a
Write c
caa
Tnsruchios dpreeduwes

ppbise t
avuguage Spechally
and inambiqhous
Hadhes Poovded
an
tained to Csy ou preaduses
Operakos

manulachuina she
Relords a madi duriny
t dapind
Hha all ttu skeps Teapird
haeu act
c t
Maunuyuyactiau
amd instruthovn
Proe e
And
Hhot t quanbiy aud qualt
ben takn

a a expected any Siqicant

ette pduct
devintens a ully reLdedaud inveiaatel

Reerds Covewn manuyactua rund distribudic

whch ealde t Completi srea a bakel t

raced, au eanes in a
empAcesibt ad

a Lwssible em
 The poe Stenag amd distribukioy 1hic
enable ehe Complat histey t h e podcts mnmze

any isk to auaity.

th

is available r e a l l auy borteh e

A System
prduck om Syy
about mxlated procts ae

Lomplaint's
u
examind te Couwe e may

inestgah, m pprpiwke meosu aken

tale

deeci ve pyoducks t Dvevout

eCwante

well WARten instrucbons Se inspeduon

aa mn
mum um and
esLeud to povide
uodd be
Teoemeti. e x Ma
Ma
sandd
Unlm
u n e maun
meul
o GaHP Teue
include anestioune

a Jonst lerwi item

CoVene

Pessonne
Premies incudhu pesonmel fadktie
amo equprunly
buildigs
Mantenama
 Stomae osting
Hataeds
And l a Prodt

upme

amd in proless Contrels

Prouctbn
Quai by Contre
Doumentaton

Sani ttion aud hgfeno

sevalidaton Droonammes
proammes
and
Valrdabion
insfimmowi o easuemet System.
tem.
Calrbration ef

Recall poo tudures

Compai nts Munagemeut

ab els Contrd
Result e previbw sey - indpeuhons aud a
a
|Ceredive steps ken
 GHP H ANDFACTURIN
ENVIRON HENT

PRODULT PERSDNNEL ENVIRONMENT

PROTECToN PROTECTION PROTECT IoN

Conko minahon Prevert Contac Aveid duwt

Cpredc &sb) schovo
Protec om prdu Proveut untnt Aved uw
Cws- Contavminaon tFum sdhug
Ce empenh Accwtale loet Avee e
humiel (ond kon

SYSTEMs

SySTEM VALDATION

The qidelines addios tiu Van eu Sustem t tevn

 Po ualiky dugs Con be disastes to o t

Patieuts and qovexnmevits o a Jealt aud a

legt pespetve Compmme) Cannot manularue

prepate qalitg pxoducrs dueto GTHP S5ue teu

he

|isa igl isk qAg Shetae, 1wich uoshunately

ecks pbets nho Cannp er t u Presabed malicton

hen they need it The phanwaleutica ndusty hs a

Tospowsibilly tensw a S and Suiie Supp

mmditnn bodu Cud tis mwsbe taken

udLaina
tn
tonsdantiou phw Eginuing and Cowsulhing

eiecs som te outser.

AMbonallyGHP can delp boost pharm ludical

Ppet opposhui he Ma Maon eConnrie hWald

wide
wide ony acept u impeat aud Sak iedines
thathave een Hanuactudtointexnatonally Teuana
GMP Standarts
 n Ves Hiu in aMP Mea ivetiin qualih
wYesti isks, and
i nu m2es
mudidne LESavee losts

inapore te Shudrrd deug Wald wide uaitty

ojetine Cenoe alieed ovy tuveql layud
aud pactial
plaww
Plai And impuebrg A Sqse
Caa ad
1 t Rau extenswe
twplemimtalon.
tepoiai baMP
te diHecn
knaoldgs 6ubeu

tht Shed be incepeated toum tu neeptun

te Maruyautusin buildin and podt divelpau
F l e produtton

REFERENCES
Assunade e plauhcals
-

A compevdinm
I.Qua
equidelines Telated mateid Vol-2 GMP 4
ispecticn
No- 15 t 29.
age
eutrel a phaimteutig bu
2. Quality System
Dipak k.Sankes
No-51 ko &.
Hane.