cosmetic gmp implementation part 6

7/24/2019 Cosmetic GMP Implementation Part 6

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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;;

cosmetic gmp implementation part 6

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