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QUALITY MANUAL
Testing
Method
Note :Blue: WI (standard, specification procedure!"ed: "ecord
#roduct $estruction "ecord
"eturn #roduct %andling "ecord
"ecall "ecord
#roduct &o'plaint "ecord
Batch #roduction "ecord
$istriution "ecord
Master production
docu'ent
Master )or'ula
Master #rod*
#rocedureMaster #ac+* #rocedure
TY# -) .M# $-&UMNT/
/pecification0
/tandard
S.O.P.
1alidation #rotocol "eport
Wor+ #rotocol
(W#!
"a2 pac+aging 'aterial
Bul+
)inished product
Testing result record and report
/tailit3 test record
/a'pling record
Microial and particle 'onitoring record
4uip'ent /tatusMaterial /tatus
#roduct /tatus
Identit30
Lael
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Manufacturing "ecords
Master Formula Record
Batch Manufacturing Record
Content
Format
Approval and Storage
Change Control
In Process Controls, Specifications, and Results
Bul Storage and !a"eling
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Another t#pe of documentation is the form used
for recording data as it is taen during the
performance of tass, tests, or events$ %hese are forms &datasheets, or data record
forms', reports, "atch processing records, and
e(uipment log "oos$ %hese documents provide the evidence that the
ra) materials, facilit# environment, the production
process, and the final product consistentl# meet
the esta"lished (ualit# re(uirements$ Record legi"l# in permanent in
.M# "&-"$/
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&hec+ 2hether control records are 'aintained for:
a$ Ra) materials and primar# pacaging materials,
documenting disposition of * released materials re+ected materials$
"$ Manufacturing of "atches, documenting the*
inds, lots and (uantities of material used$ processing, handling, transferring, holding and filling$ sampling, controlling, ad+usting and re)oring$ code mars of "atches and finished products$
c$ Finished products, documenting sampling, individual
la"orator# controls, test results and control status$d$ istri"ution, documenting initial interstate shipment, code
mars and consignees$
"&-"$/ MAINTNAN&
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Finished product specification should include*
esignated name, and internal code reference ifapplica"le
Master Formula num"er escription of finished product and its pacage details -ualitative and (uantitative re(uirement )ith
acceptance limits irection for sampling and testing, or reference to an
approved procedure
Storage condition or precautions, if an# Shelf life, if an# Batch num"ering re(uirement &including manufacturing
date or e.pir# date '
)INI/%$ #"-$U&T /#&I)I&ATI-N
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MA/T" )-"MULA
%he master formula should "e availa"le upon re(uest$A printed master formula and manufacturing instructions for each
product must "e prepared, endorsed, and dated "# the o)ner,
manager, or competent person delegated "# management$
/herever possi"le a second competent person should chec,
reconcile, endorse, and date formula instructions$ %he master formula can "e divided "# * processing master formula pacaging master formula
%ranscription from the master documents should "e "#
photocop#ing or computer printout$ A competent person should
initial each document "efore issue to signif# that it is complete,
legi"le and appropriate$ Instructions should prefera"l# "e
printed$
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Should "e prepared for each "atch of product$
0ach Batch Processing Record should include the follo)ing * name of product "atch or code num"er master "atch formula and num"er "rief processing process
processing date and #ield identit# of individual ma+or e(uipment 1 lines or location used records of cleaning of e(uipment used for processing as
appropriate in2process control and la"orator# results, such as p3 and
temperature test records
an# sampling performed during various steps of processing an# investigation of specific failure or discrepancies results of e.aminations on "ul products
BAT&% #"-&//IN. "&-"$
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The 'aster processing docu'entsshould include at leastthe follo)ing *a$ product name"$ "atch si4ec$ a description of the product &form, color, odor, etc'd$ a list of all materials and the (uantit# to "e used
e$ e(uipment to "e used and processing location5f$ theoretical or e.pected #ield5g$ ade(uate step2"#2step directions for manufacture*
precautions to "e taen )ith regard to product andpersonal safet#
e(uipment to "e used and ho) to clean it to prevent
cross2contamination5 se(uence of adding materials5 mi.ing times, temperatures5 in2process control and storage condition
#"-&//IN. MA/T" )-"MULA
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BAT&% #"-&//IN. "&-"$%he manufacture of the "atch must proceed in accordance )ith these
documents, and the follo)ing must "e included*a$ the actual )eights of materials and, )here given, the uni(ue
identif#ing num"er$ %hese )eights should, )here possi"le, "e
independentl# checed, and "oth )eigher and checer should initial
the record sheet5
"$ the initials of the operator or supervisor for each step immediatel#after it has "een performed5
c$ the actual #ield5
d$ a record of all samples taen and the results of tests performed5
e$ the "atch num"er )hich specificall# identifies it and distinguishes it
from all other "atches5
f$ )here applica"le, a date after )hich the product must not "e used$
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M). Batch "ecord %eader
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M). Batch "ecord#reli'inar3 #recautions
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Manufacturing Batch "ecord
#rocessing /teps
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Manufacturing Batch "ecord/a'pling0Bul+ /torage
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Manufacturing Batch "ecordYield $eter'ination0/ign -ff
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#A&5A.IN. MA/T" )-"MULA
The master packaging documentsmust include atleast the followin whe!e a""lica#le$a% the name of the "!oduct% the contents of the "!ima!' containe! #' (olume o!
weiht&c% a !efe!ence to the s"eci)cation of all mate!ials
!e*ui!ed fo! the "ac+ain and la#ellin of the"!oduct&
d% an' s"ecial inst!uctions o! "!ecautions, includina!ea clea!ance chec+
e% Desc!i"tion of "ac+ain "!ocess&
f% In-"!ocess cont!ol, with sam"lin inst!uction&% "!o(ision fo! calculation of 'ield o! !econciliation%
An accu!ate co"' of the maste! "ac+ain and la#ellininst!uctions must #e made fo! each #atch of "!oduct#efo!e it is manufactu!ed%
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Should "e prepared for each "atch of product$
0ach Batch Processing Record should include the follo)ing * name of product "atch 1 code num"er "atch formula and "rief pacaging process pacaging date
%heoretical and actual #ield identit# of individual ma+or e(uipment 1 lines or location used records of cleaning of e(uipment used for pacaging process in2process control and la"orator# results, such as volume and
product )eigh pacaging line clearance records 6pir3 date, if shelf life is less than 78 'onths an# investigation of specific failure or discrepancies disposition and identit# of (uarantine la"el
BAT&% #A&5A.IN. "&-"$
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#ac+aging "ecords
Pacaging Records Content Format
Approval and Storage
Change Control
In Process Controls, Specifications, and Results
Product !a"els
Preparation 2 Storage
6rdering 2 Inventor#
Proofing 2 ispensing
Acceptance 2 Reconciliation
Counting 2 Returns
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LABLIN. /Y/TM
!a"eling s#stems are used to identif# *
the status of the material, product, e(uipment ,la"orator# reagent, or facilit#
restricted areas, and )arning la"els$
%here are 7 classes of la"els * la"el for finished products la"el used )ithin the factor# to control process
Reference standards &"oth primar# and secondar#'must "e appropriatel# la"eled and the issuancemust "e controlled
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MATERIAL / PRODUCT NAME !!!!""
#C TE$TIN% REPORT NO !!!!"" $I%N !"""""
TE$TIN% DONE &' !!!!"" DATE !"""""E(PIRE DATE !!!!""
RETE$TIN% $)OULD &E DONE !!!!""
#C DEPARTMENT
APPRO*ED / RELEA$ED
MATERIAL / PRODUCT NAME !!!!"" TE$TIN% DATE
&ATC) NO" !!!!"" 9999*
$UPPLIER / PRINCIPLE NAME !!!!"" $AMPLIN% &'
#UANTIT' !!!!"" 9999*
#C DEPARTMENT
&EIN% RETE$TEDMATERIAL / PRODUCT NAME !!!!""
&ATC) NO" !!!!""
#C TE$TI N% REPORT NO !!!!"" $I %N !"""""
TE$TIN% DONE &' !!!!"" DATE !"""""
#C DEPARTMENT
RE+U$ED / RE,ECTED
MATERIAL / PRODUCT NAME !!!!""
&ATC) NO !!!!""
INTERNAL CODE !!!!"" $I%N !"""""$AMPLIN% DONE &' !!!!"" DATE !"""""
#C DEPARTMENT
#UARANTINE
.RODUCT STATUS /A0E/S
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Record for each testing, assa# result and release or
re+ection of starting materials, intermediates, "ul andfinished product should "e maintained$
-C record ma# consist of * date of test
identification of the material supplier name date of receipt original "atch num"er if an# "atch num"er (ualit# control num"er (uantit# received date of sampling (ualit# control results
QUALITY &-NT"-L "&-"$
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Qualit3 &ontrol Testing Sampling
!a"eling
Sample Control
%esting
Methods Specifications
Result 3andling
6ut of Specification Result 3andling
Approvals
Record Maintenance and Securit#
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")"N&/
8$ AS0A9 :uidelines for Cosmetic :MP &7;;