DCCUMLN1A1ICN kAC1ICL

IN1kCDUC1ICN
uocomeot ls a wrlLLen reporL or record LhaL provldes lnformaLlon especlally of an offlclal or legal naLure
uocomeototloo ls a meLhod of preparlng a wrlLLen maLerlal whlch descrlbe Lhe process ln Lerms of
speclflcaLlon lnsLrucLlons eLc
urug and cosmeLlc rules
O 1he druqs ond cosmetic ru/es under Lhe condlLlons of llcenses" and under schedule M
requlre a manufacLurer of drugs Lo malnLaln varlous records
Jf documenfon sysem consss?
O WrlLLen speclflcaLlon
O uescrlpLlons
O rocedures
O lnsLrucLlons
O CbservaLlon/execuLlon daLa
Imporfnce of Documenfon
O lL provldes necessary worklng deLalls
O 8educes Lhe rlsk of mlsLake
O Pelp ln Lraclng Lhe devlaLlon from Lhe expecLed yleld
O 1hey help ln decreaslng Lhe baLch Lo baLch varlaLlon so LhaL quallLy of producL ls kepL wlLhln
Lhe llmlLs of accepLablllLy
O Consldered as Lhe hlsLory of baLch operaLlons
O SelflnspecLlon of procedure
***uocomeototloo ooJ tecotJs are essenLlal for obLalnlng accredlLaLlon cerLlflcaLlon of l5Os and
approvals by leJetol 8oJles
DocumenfonImporfn Arefs
O arLlculars wlLh respecL Lo Lhelr sLorage sLablllLy and handllng
O lnsLrucLlon for all manufacLurlng and packaglng procedure
O lnsLrucLlon for nonproducL relaLed operaLlons
O rocedure for LesLlng
O SpeclflcaLlon of sLarLlng maLerlals packlng maLerlals and producLs for Lhe compllance by Lhe
quallLy conLrol deparLmenL
MAS1Lk ICkMULA kLCCkDS
,ostet fotmolo tecotJs are deflned as wrlLLen procedure LhaL glve Lhe compleLe descrlpLlon of
all aspecLs of lLs manufacLure packlng and conLrol wlLh an lnfecLlon Lo ensure Lhe purlLy ldenLlfy
quallLy and sLrengLh of each dosage unlL Lhrough lLs shelf llfe
I nc|udes e fo||owng nformfon
O Speclfylng a flxed formulaLlon
O ldenLlfylng quallLy crlLerla for componenLs
O rovldlng a seL of manufacLurlng lnsLrucLlon ln clear Lerms
O uescrlblng sysLemaLlc sampllng procedures
O LlsLlng preclse assays LesLs eLc
O LsLabllshlng meLhods for ensurlng compleLe accounLablllLy for all maLerlals lncludlng
packlng and labelllng
1ypes of MasLer lormula 8ecords
O 1he masLer formula records glve toottloo of lngredlenLs ln Lhe formulaLlon
O MasLer baLch formula records whlch speclfy obsolote omooots of speclflc poLenL
lngredlenLs and exclplenLs
MAS1Lk kCDUC1ICN AND CCN1kCL kLCCkDS
,ostet toJoctloo ooJ coottol tecotJs are deflned as deLalled wrlLLen lnsLrucLlons lncludlng all
operaLlons sLarLlng from dlspenslng of raw maLerlals Llll flnlshlng of bulk producLs and packaglng
operaLlon of a parLlcular producL
MasLer producLlon and conLrol record lncludes baLch slze daLe of manufacLure and full
slgnaLure (hand wrlLLen) by one person and furLher lndependenLly checked daLed and slgned by second
person
SLCuLnCL Cl 9 Su8SLC1lCn


8A1CP 8CuuC1lCn Anu CCn18CL 8LCC8uS
8aLch producLlon and conLrol records shall be prepared for each baLch of drug producL
produced and shall lnclude compleLe lnformaLlon relaLlng Lo Lhe producLlon and conLrol of each baLch
1ese records sf|| nc|ude
O An accuraLe reproducLlon of Lhe approprlaLe masLer producLlon or conLrol record checked
for accuracy daLed and slgned
O uocumenLaLlon LhaL each slgnlflcanL sLep ln Lhe manufacLure processlng packlng or
holdlng of Lhe baLch was accompllshed
O uaLes
O ldenLlLy of lndlvldual ma[or equlpmenL and llnes used
O Speclflc ldenLlflcaLlon of each baLch of componenL or lnprocess maLerlal used
O WelghLs and measures of componenLs used ln Lhe course of processlng
O lnprocess and laboraLory conLrol resulLs
O lnspecLlon of Lhe packaglng and labellng area before and afLer use
O A sLaLemenL of Lhe acLual yleld and a sLaLemenL of Lhe percenLage of LheoreLlcal yleld aL
approprlaLe phases of processlng
O CompleLe labellng conLrol records lncludlng speclmens or coples of all labellng used
O uescrlpLlon of drug producL conLalners and closures
O Any sampllng performed
O ldenLlflcaLlon of Lhe persons performlng and dlrecLly supervlslng or checklng each slgnlflcanL
sLep ln Lhe operaLlon
O Any lnvesLlgaLlon made accordlng Lo
O 8esulLs of examlnaLlons made ln accordance wlLh
8AW MA1L8lALS
1e scedu|e U o e drugs fnd cosmec ru|es requre fo||owng pfrcu|frs o be sown n e rfw
mferf| records
O uaLe of recelpL
O lnvolce number
O name and address of manufacLurer/suppller
O 8aLch number
O CuanLlLy recelved
O ack slze
O uaLe of manufacLure
O uaLe of explry
O uaLe of analysls and release/re[ecLlon by quallLy conLrol
O AnalyLlcal reporL number
O CuanLlLy lssued
O uaLe of lssue
O name and baLch number of Lhe producL for manufacLure of whlch lssued
O roper dlsposal of sLocks
ICkMA1
FORMAT
15
Date of
receipt
Invoice
number &
date
Name &
Address of
suppIier
Qty
Recd
(pack size)
B. No.
Mfg
date
Exp
date
Name &
Address of
manufacturer
Opinion
Of Q.C.
Dept
QC
Report
No.& Date
Name of the materiaI:
RECEIPT
Date
Of
Issue
Qty
issued
Name & B. No.
of product for
which issued
BaIance
ParticuIars of
disposaI if not
used
Sign of issuing
person
ISSUE/DISPOSAL


Lfbe|s fnd prned pfckfgng mferf| records
1he lndlan CMs requlre Lhe records of labels and prlnLed packaglng maLerlals lndlcaLlng recelpL
examlnaLlon relaLlng Lo LesLlng and wheLher accepLed or re[ecLed Lo be malnLalned
Labels
O WhaL musL be labelled?
4 ConLalners equlpmenL premlses producLs lnLermedlaLes samples sLandards eLc
4 SLaLus (quaranLlned accepLed re[ecLed clean)
O Who has responslblllLy for labelllng?
4 CC and producLlon for sLaLus labels
4 llnal producL lnLermedlaLes reagenLs eLc
Drug produc confner c|osure fnd |fbe||ng records
1hese records shall lnclude Lhe followlng
O 1he ldenLlLy and quanLlLy of each shlpmenL of each loL of componenLs drug producL
conLalners closures and labelllng
O 1he resulLs of any LesL or examlnaLlon performed
O An lndlvldual lnvenLory record of each componenL drug producL conLalner and closure and
for each componenL a reconclllaLlon of Lhe use of each loL of such componenL
O uocumenLaLlon of Lhe examlnaLlon and revlew of labels
O 1he dlsposlLlon of re[ecLed componenLs drug producL conLalners closure and labelllng
Drug product container, cIosure, and
IabeIIing records
18
uaLe of
recelpL
CLy
recelved
lnvolce no
uaLe name
address
ConslgnmenL
number
Cplnlon
of
CC
CC reporL no
daLe
uaLe
Cf
lssue
CLy
lssued
8aLch no for
whlch lssued
balance arLlculars
of dlsposal
lf noL used
Slgn of
lssulng
person
Name of the materiaI:
RECEIPT
ISSUE /DISPOSAL
;UALI1 CCN1kCL kLCCkDS
1he quallLy conLrol records musL show
O 1he daLe of performance of LesL
O ldenLlflcaLlon of maLerlal
O name of suppller(ln case of raw maLerlals)
O uaLe of recelpL
O 8aLch number
O CuanLlLy recelved (ln case of raw maLerlals) (baLch slze ln case of flnlshed producL)
O uaLe and quanLlLy of sample Laken
O SpeclflcaLlons employed for LesLlng
O All daLa secured ln Lhe course of each LesL lncludlng all graphs charLs prlnLouLs eLc
O CalculaLlons performed ln connecLlon wlLh lncludlng unlLs of measures converslon facLors
and equlvalence facLor
O A sLaLemenL of Lhe resulL of LesLs and how Lhe resulLs compare wlLh esLabllshed sLandards
of ldenLlLy purlLy and sLrengLh
O 1he lnlLlals or slgnaLure of person who performs Lhe LesLs
O CerLlflcaLe number lssued
O ulsposlLlon of Lhe quallLy conLrol unlL accepLlng or re[ecLlng Lhe maLerlal
8LlL8LnCL
O Cood ManufacLurlng racLlce CuallLy ConLrol Culdellnes 8aslc SLandard ln Lhe
ManufacLure Cf urugs harmaceuLlcals Companlon volume Lo Pandbooks Cf urug Laws 8y
ML Mehra
O Pow Lo pracLlce CMs Sharma
O harmaceuLlcal roducLlon And ManagemenL CvS subrahmanyam