TRAINING COURSE GMP AUDITOR TRAINING
CONTENT OF PRESENTATION I. Introduction
Objectives Description of GMP Audit Scope of GMP Audit Benefits of GMP Audit Te !e" princip#e of GMP Audit Te ro#e of GMP Auditor
2. Managing the GMP Audit program
Process F#o$ for M%n%&in& of %n %udit pro&r%' Autorit" of %udit pro&r%' Est%b#isin& te %udit pro&r%' Audit pro&r%' i'p#e'ent%tion Monitorin& %nd Revie$in& te %udit pro&r%'
. Audit Acti!itie"
Overvie$ of Audit Activities Initi%tin& te %udit Conductin& Docu'ent Revie$ Prep%rin& for On site %udit %ctivities Conductin& on(site %udit %ctivities Prep%rin&) %pprovin& * distributin& te %udit report Co'p#etin& * Conductin& Fo##o$ up
#. Audit $ormat %. Conc&u"ion
INTRODUCTION
INTRODUCTION
Good M%nuf%cturin& Pr%ctice +GMP, is te p%rt of -u%#it" Assur%nce t%t ensures t%t products %re produced %nd contro##ed consistent#" %nd re#i%b#". Tis consistenc" of production %nd contro# is essenti%#. It c%n on#" co'e %bout b" %vin& c#e%r descriptions of te $%" in $ic te $or! $i## be done.
GMP specific%##" %ddresses ris!s of cross(cont%'in%tion %nd 'i/(up t%t c%nnot be fu##" contro##ed b" testin& of te fin%# product.
Tese ris!s c%n best be contro##ed b" %vin& % proper#" '%n%&ed s"ste' of $or!in& t%t t%!es te' into %ccount. Tis 'e%ns t%t te 0u%#it" cec!in& s"ste' 'ust be desi&ned $it tese ris!s in 'ind %nd set out to find $eter %n" errors %ve occurred.
O'(ECTI)ES
To define the activities and requirements of GMP Audit
To identify the roles and benefits of GMP Audit in a Food Safety Management System
To learn how to plan, perform and monitor GMP Audit
DE$INITION
GMP Audit! is an independent e"amination of a quality system #t measures the effectiveness of an organisation$s Food Safety Management System% #t is a documented and systematic tool #t should be done periodically by independent and qualified people Audit! itself is a checking system, &'T a quality assessment
As a communication tool of management policies%
All personnel have to understand and do their (obs well
RO*ES O$ AUDIT
As a powerful tool to measure the effectiveness of Food Safety Management System
)valuates manufacturer*s compliance with GMP in all aspects related production and quality control
+etects any shortcomings in the implementation of GMP
ecommend the necessary corrective and preventive actions
SCOPE O$ GMP AUDIT +,
Ensures GMP Audit p#%n covers %## te %re%s %s per re0uired fre0uenc" GMP Audit sou#d inc#ude %## points re#%ted to Fo##o$in& Modu#es 1 ( Person%# 2"&iene ( C#e%nin& * S%nit%tion ( Pest Contro# ( Pre'ises ( Production ( -u%#it" Contro#
Ensures corrective %ctions %&reed in #%st %udit sou#d be revie$ed
SUMMAR GMP Product Recall Complaints
Personnel ! ! A C E R
Premise
Contract Manuacturing & Analysis
Storage
Audit Documentation
Equipment
Sanitation & Hygiene
Production Quality Control
'ASIC PRINCIP*ES O$
GOOD MANU$ACURING PRACTICES
P%rt of -A $ic ensures t%t products %re con"i"tent&/ produced and contro&&ed to contro&&ed to te 0u%#it" st%nd%rds %ppropri%te %ppropri%te to teir intended use.
Mini'i3e ris!s 4 5 cross cont%'in%tion 5 'i/ up
Ensure products6'%teri%#s %re tr%ce%b#e to te ori&in%# source.
Product testin& is not re#i%b#e $%" to %ssure product 0u%#it". Sou#d B7I8D 0u%#it" into te product9
Production %nd 0u%#it" contro# functions sou#d be independent of e%c oter.
'ASIC PRINCIP*ES O$
GOOD MANU$ACURING PRACTICES +,A## '%nuf%cturin& process %re c#e%r#" defined %nd s"ste'%tic%##" revie$ed. A## necess%r" f%ci#ities6resources for GMP sou#d be provided 4
%de0u%te) 0u%#ified %nd $e##(tr%ined personne# suit%b#e pre'ises %nd sufficient sp%ce suit%b#e #oc%tion &ood person%# "&iene %nd proper s%nit%tion suit%b#e e0uip'ent %nd services
'ASIC PRINCIP*ES O$
GOOD MANU$ACURING PRACTICES +2A## necess%r" f%ci#ities6resources for GMP sou#d be provided 4
c#e%r#" defined '%nuf%cturin& processes usin& un%'bi&uous #%n&u%&e &ood docu'ent%tion s"ste' %ppropri%te stor%&e %nd tr%nsport s"ste'%tic intern%# 0u%#it" %udit proper product rec%## s"ste' ri&t %ndin& of co'p#%ints co'preensive corrective %nd preventive %ction
'ASIC PRINCIP*ES O$
0UA*IT CONTRO* +,-C is p%rt of GMP. -C is concerned $it s%'p#in&) specific%tion %nd testin&. M%nuf%cturer sou#d %ve % -C dep%rt'ent. -C sou#d be e%ded b" %n %ppropri%te#" 0u%#ified %nd e/perienced person. -C sou#d be independent fro' production %nd oter dep%rt'ents. Ensure t%t te necess%r" %nd re#ev%nt tests %re %ctu%##" c%rried out. Ensure t%t no '%teri%#s or products $i## be re#e%sed for s%#e or supp#") unti# teir 0u%#it" %ve been ev%#u%ted %nd jud&ed to be s%tisf%ctor".
'ASIC PRINCIP*ES O$
0UA*IT CONTRO* +,Ade0u%te f%ci#ities) tr%ined personne# %nd %pproved procedures sou#d be %v%i#%b#e for s%'p#in&) inspectin& %nd testin& %nd) $ere %ppropri%te) environ'ent 'onitorin&. S%'p#in& b" -C personne# * testin& b" %pproved 'etods.
Approved test 'etods.
M%inten%nce of -C records * f%i#ure investi&%tion records.
'ASIC PRINCIP*ES O$
0UA*IT CONTRO* +2
In&redients co'p#" $it re&u#%tor" specific%tion +&r%de) co'position) stren&t,
Revie$ %nd ev%#u%tion of production docu'ent%tion
Assess'ent of process devi%tions
Re#e%se of b%tces b" %utori3ed person
Sufficient reference s%'p#es of st%rtin& '%teri%#s %nd finised products
OT1ER DUTIES O$ 0C Establish QC procedures Manage reference standards Ensure correct labeling Stability testing (if applicable) Complaint investigation Environmental monitoring
0UA*IT CONTRO* ACTI)ITIES -C sou#d cover te fo##o$in&4 S%'p#in& b. c. Specific%tion Testin& d. e. Re#e%se procedures f. Rec%##s %nd co'p#%ints &. Decision '%!in& in %## 0u%#it" '%tters . Definition of product 0u%#it" i. 8%bor%tor" oper%tions j. Re#e%se %utori3%tion !. Investi&%tion %nd reportin&
/A 0S /1
Te ter's quality assurance %nd quality control %re often used interc%n&e%b#" to refer to te %ctions perfor'ed for ensurin& te 0u%#it" of % product) service) or process. Bot ter's) o$ever) %ve '%n" interpret%tions bec%use of te 'u#tip#e definitions for te $ords :%ssur%nce: %nd :contro#.: Te definitions be#o$) for e/%'p#e) point to$%rd % specific distinction bet$een tese t$o ter's4
Assurance The act%ct of giving confidence, the state A""urance 4 Te of &ivin& confidence) teof being or the act of or ma.ing certain% st%tecertain, of bein& cert%in) te %ct of '%!in& cert%in.
Contro& 4 An ev%#u%tion to indic%te needed corrective responses; te %ct of &uidin& or te st%te of % process in $ic te v%ri%bi#it" is %ttribut%b#e to % const%nt s"ste' of c%nce c%uses.
0ua&it/ a""urance 4 A## te p#%nned %nd s"ste'%tic %ctivities i'p#e'ented $itin te 0u%#it" s"ste' t%t c%n be de'onstr%ted to provide confidence % product or service $i## fu#fi## re0uire'ents for 0u%#it".
0ua&it/ contro& 4Te oper%tion%# tecni0ues %nd %ctivities used to fu#fi## re0uire'ents for 0u%#it".
0UA*IT RE*ATIONS1IP
0ua&it/ Management 0ua&it/ A""urance G.M.P. 0ua&it/ Contro&
'ENE$ITS O$ GMP AUDIT
Te##s "ou te "&iene st%nd%rd of %re%
Identif" te root of % prob#e' %nd p#%n for corrective %nd preventive %ctions $it ti'e#ine
Acieve better %##oc%tion of resources
Ab#e to %void potenti%##" bi& Food S%fet" Ris!
8e%rn $%t %n %uditors #oo! for
Continuous i'prove'ent
3E PRINCIP*ES O$ GMP AUDIT Approache" to4ard" GMP Audit 5 Independent 5 Evidence(b%sed %ppro%c A&& acti!itie" re&ated to Audit "hou&d 5 be revie$ed b" %n independent p%rt" 5 be % se#f(%ppr%is%# s"ste' 5 %ve % s%'p#in& p#%n %nd tr%c!in& s"ste' 5 be open) constructive %nd effective Strategie" in conducting audit 5 As! $it te b%sic %udit 0uestions %bout te 0u%#it" s"ste' in p#%ce 5 St%rt $it what, why, how, who, where, when
PRINCIP*E O$ AN AUDITOR
Etic%#
Profession%#
F%ir
Auditin& Tecni0ues
Don5t
Do
Stop t%#!in&
C%#' te Auditee
Focus on #istenin&
Re'ove distr%ctions
E'p%ti3e
P%tience
2o#d "our te'per
-uestion
Be u'b#e 8ISTEN
GUIDANCE 61EN CONDUCTING AN AUDIT 2
Auditing should be seen as a positive process not a fault finding
2
Audits need to be documented
2
Prior to the audit date, an auditor needs to review the quality system documentation, corrective and preventive actions, and past audit findings%
2
+uring an audit, an auditor need to see evidences that the processes are being done in accordance to procedures and policies
GUIDANCE $OR AUDITEE 6hen 7eing audited 5 5 5 5 5
=o#unteer infor'%tion Report deficiencies %nd difficu#ties if "ou !no$ of %n" Be onest) open %nd cooper%tive Ensure t%t under#"in& c%uses %re identified As! te %uditor if "ou>re not sure
MANAGING GMP AUDIT
$*O6 C1ART O$ AUDIT Authority for the audit programme
Establishing the GMP audit program obectives responsibilitties resources procedure and guidance
Act
Improving the audit programme
Implementing GMP audit program scheduling audits evaluating auditors selecting audit team directing audit activities maintaining records
Monitoring & reviewing the GMP audit program monitoring & revieing identifying needs for corrective identifying needs for prevention actions identifying opportunities for i mprovement
Plan
competence and evaluation of auditors
o
Audit activities
Check
RESOURCES $OR AUDIT
Consider%tions sou#d be &iven to te fo##o$in&4
Resources Audit tecni0ues Processes to %cieve %nd '%int%in te co'petenc" of %uditors %nd to i'prove teir perfor'%nce Co'petenc" %nd %v%i#%bi#it" of %uditor Av%i#%b#e ti'e for %uditin&
AUDITING ACTI)ITIES
O)ER)IE6 O$ AUDIT ACTI)ITES P&anning and "chedu&ing audit Conducting document re!ie4 Preparing 8or on9"ite acti!itie" Conducting audit Prepare audit report Conducting 8o&&o49up
AUDIT ACTI)ITIES
For'in& %n %udit te%' %nd %ssi&n ro#es %nd responsibi#it" %nd %&reed on te scope
Conductin& docu'ent revie$
5
Revie$ docu'ents +SOPs) %udit findin&s) corrective %ction6preventive %ction) etc.,) cec! te inte&rit" of te 0u%#it" s"ste' %nd v%rious contro#s %re effective
Prep%rin& for te on(site %udit %ctivities
Preparing audit plan Assigning work to the auditors Preparing work documents (eg. audit checklists, sampling plans, forms for recording information; questionnaires)
AUDIT DOCUMENTATION 5
Audit p#%n
5
sou#d be sent to Auditee prior to %udit %ctivit" findin&s fro' te #%st %udit sou#d be %#so 'entioned
Audit note sou#d inc#ude %n
%udit 0uestionn%ire %## records %nd co''ents durin& te %udit
5 Audit report is %n offici%#
docu'ent to report te %udit findin&s
E?AMP8E OF AN A7DIT C2EC@8IST Audit for'%t for %n %udit cec!#ist
!r" #o"
G
Section ; Per"ona& 1/giene
A#'%r%i 7nifor' Protoco# 'ust be fo##o$ed b" e%c e'p#o"ee S'o!in& 6 E%tin& is not %##o$ed inside te '%nuf%cturin& %re%s. A## e'p#o"ees 'ust under&one tro B%#%di% Medic%# test A## cuts * &r%3es on e/posed s!in s%## be covered Is re&u#%r fo&&in& conducted Are records %v%i#%b#e for revie$ Offices 6 Hor!p#%ce s%## be !ept c#e%n * tid"
App&ica7&e .e" No
T/pe PRP $SR
A
Rating ' C D
Remar:"
Definitions
PRP" 9 Tese %re b%sic%##" te &eneric contro#s in %n" t"pe of food business oper%tion. Tese %re to be %pp#ied in %## t"pes of food business so %s to '%int%in % "&ienic environ'ent to reduce te ris! to te Food S%fet". E/%'p#e 1 GMP) C%#ibr%tion) C#e%nin& * S%nit%tion etc
$ood Sa8et/ Ri": 1 %re te conditions $ere PRPs b%sed on oper%tion%# conditions $i## %ve direct i'p%ct on Food S%fet" of Product. Tese points %re critic%# for Food S%fet" %nd sou#d be contro# to prevent %n" %3%rd to product. E/%'p#e 1 Pest on e0uip'ent c%n #e%d pest cont%'in%tion in product) bro!en &#%ss) %n&in& $ires on fi##er c%n #e%d to forei&n bod" ris!.
Definitions A77re < A
'
C
Categorie"
De8inition"
Sati"8actor/ Meets te re0uire'ent trou&out te dep%rt'ent
Minor De!iation
Ma=or De!iation
Fe$ incidence $ere dep%rt'ent $%s not %b#e to fu#fi## te re0uire'ents +B%sed on situ%tion * incidence critic%#it", More no of incidences $ere te dep%rt'ent $%s not %b#e to fu#fi## te re0uire'ents +B%sed on situ%tion * incidence critic%#it",
Score
Corrective Actions not t%!en p#%ce for #%st %udit
D
Critica&
A sin&#e incidence c%usin& Food S%fet" Ris! to product e.&. Bro!en G#%ss on f#oor) pest on e0uip'ent) Forei&n bod" issue Corrective Actions not t%!en p#%ce for consecutive #%st t$o %udits
(
E?AMP8E OF AN A7DIT C2EC@8IST CHEC"#$% !#S& '(R %MP ASSESSME$& Date Auditor
3 3
!ocation Auditee
DESCR#P&#($
%MP*RE'*
PARAME&ER
Personnel
4%5%4 6%4%5 5%4%6 49%4%4 :%4 :%; :%< = :%49 :%45%5
7 'rgani8ation structure 7 Personnel hygiene 7 Training record 7 +esign and layout of defined area 7 Flow of personnel and goods 7 Structure of the storage area, based on GMP 7 >0A1 system 7 ecord of monitoring parameter 7 Pest record program 7 The map of bait 7 The cleanliness of weighing apparatus 7 ecord of maintenance and calibration of weighing apparatus 7 The effectiveness of label system 7 #nventory stoc. control
Storage area
Sanitation
:%4 6%:
+ocumentation
?%: 49%5%5%: 49%5%5%4
3 3
)arehouse
A+D#& '#$D#
%$ A7DITING ACTI=ITIES +,
Conducting on9"ite audit acti!itie"
Conduct openin& 'eetin&
Good co''unic%tion durin& te %udit
Ro#es of escort %nd observer
Steps in conductin& on site %udit4
Intervie$s $it different personne# C%rr" out bot ori3ont%# %nd vertic%# %udits. Focus on s%fet" %nd 0u%#it" of product. 7se JTr%ce(b%c!K 'etod
A7DITING ACTI=ITIES +,
Generating audit 8inding"
Eiter PRP or Food S%fet" Ris!
Eiter confor'it" or non(confor'it"
Sort out iso#%ted or s"ste'ic deficiencies
Iso#%ted deficienc"4 Tends to %ppen r%ndo'#"; no 'e%nin&fu# p%ttern; r%re#" %ppens
S"ste'ic deficienc"4 Cou#d be connected to % p%rticu#%r process) product) '%teri%#) person or or&%nis%tion; so$s p%ttern; %ppens 'ore t%n once
AUDIT MONITORING Te %udit findin& c%n be c#%ssified into &roups4 5
Comp&iance 5 S%tisf%ctor" 6Ade0u%te 5 Outst%ndin& Non9comp&iance 5 Critic%# deficienc" 5 M%jor deficienc" 5 Minor deficienc"
AUDIT REPORT
Objectives
Audit scope Identific%tion of tr%ined %uditor D%te %nd p#%ce $ere te on(site %udit %ctivities $ere conducted
Audit criteri% %nd findin&s Conc#usions
AUDIT REPORT
On#" St%nd%rd for'%ts c%n be used for Audit Report
7su%##" inc#ude n%'e %nd #oc%tion of %uditee) d%te of %udit) %udit p#%n) %udit observ%tions) c#%ssific%tion of non( co'p#i%nces) reco''end%tions or e/pect%tions
Sou#d $rite %&%inst % st%nd%rd
Focus on deficient conditions %nd not peop#e
Inc#ude %n" positive observ%tions
@eep te %udit report si'p#e %nd c#e%r
A7DIT REPORT4 AN E?AMP8E !r" #o"
G
L
Section ; Per"ona& 1/giene
App&ica7&e .e" No
T/pe PRP $SR
Offices 6 Hor!p#%ce s%## be !ept c#e%n * tid" Do f#oor dr%ins %ppe%r c#e%n) free fro' odors %nd $e## '%int%ined S'o!in& 6 E%tin& is not %##o$ed inside te '%nuf% '%nuf%ctu cturin rin %re%s. %re%s. A#'%r%i 7nifor' Protoco# 'ust be fo##o$ed b" e%c e' #o ee A## e'p#o"ees 'ust under&one tro B%#%di% Medic%# test Is re&u#%r fo&&in& conducted Are records %v%i#%b#e for revie$
√
√
√
√
√
√
√
√
√
√
√
√
Dr%ins s%## be fitted $it screens * tr%ps to pest entr"
√
√
Rating A ' C D √
Remar:"
Audit in B#endin& Roo' Audit in Fres Fi##in& +Dr%in is ne%r to recover" %re%
√
√ Audit in %n" production %re%
√
Audit in Do$n #ine
√
Audit in Outbound
√
√
√
√
Audit in RCC Fer'ent%tion roo' Audit in C2P Fi##in&
C8OS7RE Fo##o$(up %nd c#osin& of #oop4 5
Receive % s%tisf%ctor" response fro' %uditee %nd teir co''it'ent to correct for %n" deficienc"
5
Ensures CAPA identif" te root c%use %nd te" %re s%tisf%ctor") %cco'p#ised %nd docu'ented
5
Ti'efr%'e for CAPA is bein& fo##o$ed
5
=erif" %nd tr%c! CAPA b" scedu#in& % fo##o$(up %udit %nd6or re0uestin& for %n upd%ted SOP
CONC87SIONS
GMP Audit Modu#es Personne# 2"&iene H%ste M%n%&e'ent Pre'ises E0uip'ents C#e%nin& * S%nit%tion Production Contro#s -u%#it" Contro#s Docu'ent%tion Good Stor%&e Pr%ctices Good 2ouse @eepin&
$ ( # & A & # $ A S
H , % # E $ E
PERSONNE* 1GIENE
PERSONNE* 1GIENE +,
A## personne# 'ust under&o e%#t e/%'in%tion
Tr%ined in te pr%ctice of personne# "&iene
I##ness or open $ounds 1 not %##o$ed
Report to supervisors %n" conditions %dverse#" %ffect te product 0u%#it"
PERSONNE* TRAINING +,
Tr%inin&) in %ccord%nce $it % $ritten pro&r%''e for %## personne# $ose duties t%!e te' into production; or into contro# #%bor%tories; %nd for oters $ose %ctivities cou#d %ffect te 0u%#it" of te product
On induction %nd continuin& on teor" %nd pr%ctice of GMP; %pproved b" eiter te e%d of Production or -C %s %ppropri%te tr%inin& records sou#d be !ept tr%inin& before undert%!in& %n" ne$ t%s!
PERSONNE* 1GIENE +2
Avoid direct cont%ct of oper%tor>s %nds %nd products inc#udin& st%rtin&6 p%c!%&in& '%teri%#s
He%r c#e%n Over%## or unifor'
S'o!in&) e%tin&) drin!in&) ce$in& %nd !eepin& '%teri%#s not re#%ted to production not per'itted
7se of protective c#otin& in production %re%s
PERSONNE* TRAINING +2
St%ff in speci%# %re%s) e.&. $or!in& $it %3%rdous '%teri%#s sou#d be &iven specific tr%inin& Te concept of -A %nd its underst%ndin& %nd i'p#e'ent%tion sou#d be fu##" discussed durin& tr%inin& Pr%ctic%# effectiveness sou#d be periodic%##" %ssessed e.&. %ssess'ent tests) nu'ber of rejects) product co'p#%int) return products
REGU*ATION IN PRODUCTION AREA
Proibit use of rin&s) e%rrin&) %nd oter je$e#ries in production %re%
2%ir co'bin& is not %##o$ed in te '%nuf%cturin& %re%.
Proibit use of %rtifici%# e"e#%s) s"ntetic n%i#) %nd oter be%ut" %ccessories t%t c%n f%## into te products.
PERSONNE* 6IT1 I**NESS Personne# sou#d be instructed %nd encour%&ed to report to teir i''edi%te supervisor $en te" %re i## or $en te" see %n" conditions t%t '%" %dverse#" %ffect te product 0u%#it".
PROPER ATTIRE A## %utori3ed personne# enterin& te production %re%s sou#d pr%ctice &ood person%# "&iene inc#udin& $e%rin& of proper %ttire) suit%b#e e%d$e%r %nd foot$e%r. To %void cross cont%'in%tion) personne# sou#d not 'ove bet$een %re%s producin& different products.
SA$ET ATTIRE 2 Avoid direct physical contact with the product to protect from contamination% 2 Personnel should wear protective attire when wor.ing with ha8ardous materials
Dust mask
smoke mask
glo-es
goggles
moustache & .eard co-er
)ISITOR OR UNTRAINED PERSONNE*
Must be &iven infor'%tion in %dv%nce) p%rticu#%r#" %bout person%# "&iene; %nd protective c#otin& re0uire'ents
Must be %cco'p%nied %nd closely supervised %t %## ti'es
'ENE$ITS ; Per"onne& 1/giene $or per"onne& To prevent cont%'in%tion ris! t%t effect personne# e%#t
$or product To prevent cont%'in%tion of te products To '%int%in te i& st%nd%rd of product 0u%#it"
$or compan/ To s%ve on cost) %void re$or!s %nd rejects To %void consu'er co'p#%ints To %void potenti%# product rec%##
$or con"umer" To &et s%fe %nd &ood 0u%#it" product
HASTE MANAGEMENT
@aste material should be placed in suitable container and regularly collected for disposal outside the production areas% egular = timely collection of garbage Garbage bins must be properly covered at all times &o food wrapper to be thrown in garbage cans inside the production area +o not use product shipping cases as garbage bins
6ASTE MATERIA*S 1AND*ING
A## $%ste '%teri%#s sou#d be proper#" %nd#ed
Sou#d be stored proper#" %nd in % s%fe p#%ce
To/ic %nd f#%''%b#e '%teri%#s sou#d be stored in % suit%b#e desi&ned) sep%r%ted %nd enc#osed %re%
Sou#d not be %##o$ed to %ccu'u#%te
PREMISES
PREMISES DESIGN +,Te desi&n of te pre'ises depends on te '%nuf%cturin& %ctivities. 2o$ever) in &ener%# ter's) %## %re%s sou#d be desi&ned in suc % $%" t%t prevents te bui#d(up of dirt %nd dust. Te p#%nt f%ci#ities s%##4 provide sufficient sp%ce for e0uip'ent %nd stor%&e of '%teri%#s %s necess%r" for te '%inten%nce of s%nit%r" oper%tions %nd s%fe production. provide %de0u%te #i&tin&) venti#%tion or contro# e0uip'ent to 'ini'i3e cont%'in%tion. %ve %n effective pest contro# pro&r%'. cec! pests %nd pest infest%tion on % re&u#%r b%sis. provide) $ere necess%r") %de0u%te screenin& or oter protection %&%inst pests.
PREMISES DESIGN +2Bui#din&s 6 f%ci#ities sou#d be so constructed t%t 4 f#oors) $%##s) %nd cei#in&s '%" be %de0u%te#" c#e%ned %nd !ept c#e%n) %nd !ept in &ood rep%ir; f#oor 'ust be %rd) s'oot %nd i'pervious) s#opin& sufficient#" to$%rds % dr%in tus %##o$in& c#e%nin& $it $%ter; te &rounds s%## be !ept in % condition t%t $i## protect te product %&%inst cont%'in%tion) %nd to inc#ude proper stor%&e of e0uip'ent) re'ovin& #itter %nd $%ste; dr%ins %re !ept to % 'ini'u' %'ount. Teir desi&n 'ust prevent te possibi#it" of b%c!(f#o$. Open c%nne#s sou#d be e%s" to c#e%n %nd s%niti3e.
PREMISES DESIGN +In %ddition4 Tere 'ust be % $ritten c#e%nin& %nd
s%niti3%tion procedure indic%tin& $o is responsib#e for its e/ecution) te '%teri%#s used %nd 'etodo#o&". Te procedure sou#d be %ppropri%te to te %re% bein& c#e%ned. Tere sou#d %#so be % $ritten record of
c#e%nin& t%t %s been perfor'ed. Tere sou#d be '%/i'u' protection %&%inst
te entr" of insects or oter %ni'%#s. For #o%din& b%"s in p%rticu#%r) tere needs to be protection %&%inst te $e%ter %nd f#"in& %ni'%#s.
Air curtain
C*OSED DOORS > 6INDO6
√
F%ci#ities 'ust be $e## '%int%ined to prevent %n" cont%'in%tion to &et into te production %re%.
Doors %nd $indo$s 'ust %#$%"s be !ept c#osed %t %## ti'es in te production %re%. Screens 'ust be inst%##ed on $indo$s or %n" oter openin&s.
X X
SANITATION > C*EANING
C*EANING PRINCIP*ES C#e%nin& %nd s%nit%tion is % !e" consider%tion $en desi&nin& pre'ises %nd e0uip'ents to oper%te in % Food industr". Proper c#e%nin& p#%"s %n i'port%nt ro#e. Te 'etods used to est%b#is % c#e%n '%nuf%cturin& environ'ent v%r" fro' co'p%n" to co'p%n". Te &o%# is %#$%"s te s%'e) to %c0uire te #eve# of c#e%n#iness to '%int%in % i& product 0u%#it" $i#e 'ini'i3in& costs. To underst%nd te concept of c#e%n#iness) it is necess%r" to define so'e co''on $ords used in te industr". Most i'port%nt %re te $ords clean) sanitation) hygiene) clean sanitation hygiene %nd sterile. sterile
C*EANING PRINCIP*ES
C#e%nin& oper%tions s%## be perfor'ed in % '%nner to prevent cont%'in%tion of '%teri%#s %nd products.
C#e%nin& pr%ctices c%n be divided b" 4 Jdeep c#e%nin&K) Jouse!eepin& c#e%nin&K) %nd J'%inten%nce c#e%nin&K.
A## c#e%nin& co'pounds %nd s%niti3ers s%## be proper#" #%be##ed %nd stored in % #oc!ed co'p%rt'ent) %$%" fro' production %nd stor%&e %re%s.
C#e%nin& e0uip'ent %nd too#s s%## be supp#ied %nd be re%di#" %v%i#%b#e for use. A## c#e%nin& e0uip'ents s%## be '%int%ined %nd stored in suc % $%" %s not to cont%'in%te product or e0uip'ent.
'ENE$ITS ; Sanitation > C&eaning For personne# 4 To prevent cont%'in%tion ris! t%t effect personne# e%#t For product 4 To prevent cont%'in%tion of te products To '%int%in te i& st%nd%rd of product 0u%#it" For co'p%n" 4 To s%ve on cost) %void re$or!s %nd rejects To %void consu'er co'p#%ints To %void potenti%# product rec%## For consu'ers 4 To &et s%fe %nd &ood 0u%#it" product
PROCESS CONTRO*
NO EATING? DRIN3ING > SMO3ING $o
Eating, $o Drinking, $o Smoking, and $o Che/ing %um policy shall be strictly implemented as well as no spitting on the floor% Food shall not be .ept in production, warehouse or laboratory area% No Eating, No Drinking No Smoking
PRE)ENTION O$ CONTAMINATION
Prevention of cont%'in%tion sou#d be done in ever" step of '%nuf%cturin& processes T"pe of cont%'in%nt c%n v%r") st%rtin& fro' dust) &%ses) v%pors) spr%") residues fro' e0uip'ent) insect) 'icrobes) or '%" co'e fro' oper%tors c#otin&. Are% $ere so'e susceptib#e products %re processed) suc %s neutr%# p2 product sou#d be 'onitored periodic%##" for its 'icrobi%# content. Cross(cont%'in%tion sou#d be %voided trou& proper %pp#ic%tion of preventive 'e%sures Me%sures to prevent cross(cont%'in%tion %nd teir effectiveness sou#d be cec!ed periodic%##" .
6EIG1ING > MEASUREMENT Hei&in& sou#d be c%rried out 4
( in defined %re%s ( usin& c%#ibr%ted e0uip'ent. A## $ei&in& %nd 'e%sure'ent c%rried
out sou#d be4 ( recorded ( counter cec!ed
IN9PROCESS CONTRO*
Done $itin te production %re% %nd b" production peop#e %nd6or -u%#it" Contro# Sou#d be recorded %nd done %s per %pproved6$ritten SOP S%'p#in& done to verif"4 p"sic%# %spects +$ei&t) vo#u'e) %'ount) etc, te/t on #%be#s oter perfor'%nce re0uire'ents S%'p#in& '%"be conducted b%sed on need 4 durin& processin& %ctivit" durin& p%c!%&in& +fi##in& * p%c!in&, %ctivities 4 r%ndo') se0uenti%#) or st%tistic%# S%'p#es t%!en %$%" fro' te p%c!%&in& #ine sou#d not be returned if cont%iners $ere opened Record of in(process contro# sou#d be p%rt of te Production Run.
CA*I'RATION
To '%int%in te %ccur%c" %nd precision of test e0uip'ent %t %## ti'es. To ensure i&est #eve# of confidence in %## 'e%sure'ent t%t %ffect '%teri%#s disposition decision) $it unbro!en c%in of tr%ce%bi#it" to n%tion%# st%nd%rd. To deter'ine $eter te e0uip'ent is sti## fit for its intended purpose. It is b%sed on te co'p%rison of % pri'%r" st%nd%rd or instru'ent of !no$n %ccur%c" $it %noter e0uip'ent +to be c%#ibr%ted, It is used to detect) corre#%te) report or e#i'in%te b" %djust'ent of %n" v%ri%tion in te %ccur%c" of te e0uip'ent bein& c%#ibr%ted.
E0UIPMENT C*ASSI$ICATION
Critic%# e0uip'ent4
Direct 'e%sure'ent t%t %ffect te fin%# product 0u%#it" Me%sure'ent on critic%# process p%r%'eters in te process specific%tion such as !asteuri"er
Non critic%# e0uip'ent4
Indirect 'e%sure'ent t%t $i## not direct#" %ffect te fin%# product 0u%#it" S%## be '%int%ined b%sed on co'p%n" '%inten%nce scedu#e
GOOD 1OUSE3EEPING PRACTICES
GOOD 1OUSE3EEPING PRINCIP*ES A well7planned, well7e"ecuted and controlled cleaning and sanitation programme for rooms, machines and equipment is very important to achieve a hygienic standard% 1leaning and sanitation alone will not assure a hygienic standard in production% Process hygiene as well as personal hygiene are important factors% Buildings C facilities should be so constructed that clean and unclean processes and products do not mi"% The cleaning program must be performed regularly, dependent on the demand for cleaning in the specific areas% The requirements for cleaning have to be defined before establishing the cleaning program%
GOOD 1OUSE3EEPING AD)ANTAGES
5 5 5 5 5 5 5 5
A A A A A A A A
C#e%n C#e%n C#e%n C#e%n C#e%n C#e%n C#e%n C#e%n
Hor!p#%ce is 2i& in -7A8IT; Hor!p#%ce is 2i& in PROD7CTI=IT; Hor!p#%ce @eeps COSTS Do$n; Hor!p#%ce S%ves TIME; Hor!p#%ce Ensures EFFICIENT De#iver"; Hor!p#%ce Provides 2EA8T2 environ'ent; Hor!p#%ce is SAFE for peop#e to $or! in; Hor!p#%ce is 2i& in MORA8E.
'e8ore c&eaning program
A8ter c&eaning program
% S 6OR3P*ACE ORGANI@ATION SEIRI +C*EARING UP- Remo!e 4hat i" not needed and :eep 4hat i" needed
SEITON +ORGANI@ING- P&ace thing" in a "uch 4a/ that the/ can 7e ea"i&/ reached 4hene!er the/ are needed
SEISO +C*EANING- 3eep thing" c&ean and po&i"hed no tra"h an dirt in 4or:p&ace
SE3ETSU +STANDARDI@ING- Maintain c&ean&ine"" a8ter c&eaning9perpetua& c&eaning
S1ITSU3E +SE*$ DICIP*INE- Commitment? a t/pica& teaching and attitude to4ard" an/ underta:ing to in"pire pride and adherence to "tandard" e"ta7&i"hed 8or the 8our component"
% S 6OR3P*ACE ORGANI@ATION Benefit of S i'p#e'ent%tion 4 5 reduce inventor") 5 efficient on $or!p#%ce us%&e) 5 reducin& ti'e for se%rcin& '%teri%# %nd finised &oods) 5 !eep $or!p#%ce c#e%n %nd tid") 5 i'prove $or!in& condition) 5 reduce $or! %ccident) 5 incre%se discip#ine) 5 fo##o$ procedure etc.
GOOD STORAGE PRACTICES
RE0UIREMENT O$ GSP To ensure t%t $en te end product re%ces te consu'er) it is of &ood 0u%#it" %nd s%fe to use.
MATERIA* RE0UIREMENTS +,
A## inco'in& '%teri%#s sou#d be 0u%r%ntined i''edi%te#" %fter receipt unti# te" %re re#e%sed for use in production
R%$ '%teri%#s sou#d be stored under %ppropri%te condition.
Stor%&e condition sou#d be contro##ed) 'onitored %nd recorded
MATERIA* 'ASIC RE0UIREMENTS +2
Stor%&e of '%teri%#s sou#d be order#" to %void 'i/ up %nd cross cont%'in%tion
Ensure t%t tere is %n effective s"ste' in contro##in& stoc!s
Ensure t%t consu'ption of st%rtin& '%teri%#s fo##o$s 4 FIFO First(In(First(Out) or EEFO E%r#iest E/pir") First Out.
MATERIA* 'ASIC RE0UIREMENTS +
Personne# in c%r&e of r%$ '%teri%# purc%se sou#d %ve sufficient !no$#ed&e of te '%teri%#s) products %nd supp#iers of te '%teri%#s
R%$ '%teri%#s sou#d be purc%sed fro' 0u%#ified supp#iers. R%$ '%teri%#s sou#d %ve %pproved specific%tion %nd de#iveries %re %cco'p%nied $it % certific%te of %n%#"sis.
it is su&&ested to purc%se r%$ '%teri%#s direct#" fro' '%nuf%cturers or %ppointed distributors .
MATERIA* )ERI$ICATIONS St%rtin& '%teri% s
s ou e c ec e %n veri ie or teir confor'it" to specific%tions %nd be tr%ce%b#e to te p roduct.
S%'p#es of r%$ '%teri%#s sou#d be p"sic%##" cec!ed for
confor'it" to specific%tions prior to re#e%se for use. R%$ '%teri%#s sou#d be c#e%r#" #%be#ed .
A## '%teri%#s received sou#d be c#e%n %nd cec!ed for
%ppropri%te protective p%c!in& to ensure no #e%!%&e) perfo r%tion or e/posure to environ'ent.
De#iveries
of r%$ '%teri%#s t%t do not co'p#" $it specific%tion sou#d be se&re&%ted %nd disposed %ccordin& to st%nd%rd oper%tin& procedures
STOC3 MANAGEMENT > CONTRO*
receivin& * identit" inspection
stor%&e * stoc! contro#
product re#e%se) rep%c!%&in& * tr%nsport%tion
product dispos%#
RECEI)ING > INSPECTION +,A## de#iveries sou#d be cec!ed4
cont%iners %re not d%'%&ed
0u%ntit" of de#iveries
#%be#s
supp#iers n%'e * %ddress
RECEI)ING > INSPECTION +2
product infor'%tion product n%'e) b%tc no '%nuf%cturin&6e/pir" d%te) stor%&e re0uire'ents4 St%c! on p%##ets 7se st%nd%rd p%##ets $ooden p%##ets sou#d be free fro' pest Inter#oc!in& p%ttern of te bo/ for st%bi#it"
STORAGE > STOC3 CONTRO*
s"ste'%tic stor%&e s"ste' sufficient p%ss%&e $%" for e%s" 'ove'ent inspection 6 cec!in& %pp#" stoc! c%rd
proper #%be#in& scedu#ed stoc! cec! or count
#dentiication la.els
PRODUCT RE*EASE
To fo##o$ FIFO 6 FEFO s"ste'
Recec! before de#iver"
Monitor &oods condition durin& tr%nsport %nd %t de#iver"
RETURNED GOODS A!ai&a7&e 4ritten procedure4
se&re&%tion of returned &oods
#%be#in& of returned &oods investi&%tions * ev%#u%tions on4
0u%#it" %nd s%fet"
RE(ECTEDBDAMAGED GOODS App&/ 4ritten procedure se&re&%tion of returned &oods #%be#in& of returned &oods investi&%tions * ev%#u%tions on4 0u%#it") %nd s%fet" dispos%# of &oods
