8/17/2019 Validation of a Plant SSOPs-GMP-Prerequisite Programs

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Validation of a Plant’sSanitation, Standard Operating Procedures (SSOPs)

AndGMP/Prerequisite Programs

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!A""P "onsulting Group, #$#$"$

%&ile a plant’s !a'ard Anal sis "ritical "ontrol Point (!A""P) food safet s stemfocuses to pre ent, eliminate or reduce to accepta le le els potential iological,c&emical and p& sical &a'ards, it must e supported sound, *ell *ritten,implemented, monitored and alidated SSOP and GMP/Prerequisite Programs$ +f!A""P plans and critical control points (""Ps) are required regulation to e

alidated, SSOPs, GMP/Prerequisite Programs s&ould also e scientificall pro ento e effecti e de eloping and implementing *ell *ritten and implementeden ironmental monitoring programs$ n ironmental monitoring in a plant is t&escientific -ustification to management, auditors, clients and emplo ees t&at t&e time,effort and mone put fort& for t&e sanitation of direct food contact surfaces.maintaining good traffic patterns. &and *as&ing. sanitar equipment design. etc$are all effecti e$

n ironmental monitoring programs &a e man purposes, including (0) 1o assess if direct food contact surface cleaning and saniti'ing programs are effecti e to aspecified micro ial le el. (2) 1o determine if implemented GMP/Prerequisiteprograms are effecti e at reducing or eliminating cross3contamination. (4) 1o assessequipment and utensils for potential &ar orage sites. and, (5) 1o assess t&e controlof pat&ogens (e$g$, Listeria monocytogenes ) in coo6ed, read 3to3eat productproduction areas$

Gat&ering and trending data to de elop a compre&ensi e program ma ta6e a longtime ut 6no*ing *&et&er our sanitation program is actuall *or6ing efficientl ,or not, is critical to assuring safe food production$ Sampling met&ods andfrequencies, test selection, failure rate, air sampling, sampling time andspecifications are all important elements t&at s&ould e included in t&e de elopment

of a sound en ironmental program$ sta lis&ing sampling sites t&e 7one conceptis an effecti e *a for t&e design of t&e en ironmental program$ 7one 0 is areas int&e plant *&ere t&ere are direct product contact surfaces$ 7one 2 is areasimmediatel ad-acent to product contact surfaces$ 7ones 4 and 5 are areas stillfurt&er a*a from product contact surfaces$

+n general and for udgetar reasons, t&e greatest olume of sampling s&ould e*it&in 7one 0 and 7one 2 and s&ould focus on t&e presence of coliforms and aero ic

8/17/2019 Validation of a Plant SSOPs-GMP-Prerequisite Programs

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plate counts (AP")$ %&ere applica le (i$e$, post3let&alit , direct food contactsurfaces for coo6ed, read 3to3eat products) t&e testing for Listeria 3li6e organisms,

Listeria species or Listeria monocytogenes ma also e necessar or required regulation$ %&ile out3of3 specifications are to e e8pected, t&e goal is to limit suc&instances, t&roug& trac6ing and trending t&e data, to 90:; failure rate *&en

conducting coliform and A1P sampling$ Generall , for cleaning and sanitation ofdirect food contact surfaces e effecti e, t&e surfaces s&ould &a e micro ial le els of90: colon forming units ("<=) per sponge for coliform and A1P$ Ot&er companiesma set t&eir standards at 9 >: "<= per sponge or 90:: per sponge utcontinuousl *or6 to*ard t&e lo*er alue of 90:"<?s$ %&en testing for Listeriamonocytogenes , negati e results are required on direct food contact surfaces$

1&e en ironmental sampling program data *ill also determine if GMPs andprerequisite programs are properl implemented$ !ere, samples s&ould e collectedt&ree to four &ours into production to e aluate emplo ee & giene practices,&and*as&ing practices and an c&anges in traffic patterns$ 1o de elop a aseline

for applica le GMPs and prerequisite programs, plants s&ould consider testing forcoliforms, aero ic plate counts and coagulase positi e staphylococcus $ +n product,read 3to3eat areas ot& Listeria and Salmonella s&ould also e considered$ Once a

aseline is esta lis&ed t&oug& frequent testing (e$g$, *ee6l for one to t&ree mont&s),t&e sampling frequencies can e ad-usted accordingl ut increased *&ene erde iations occur a o e t&e aselines$

1&e trend to*ard sanitar equipment design &as &elped sanitation cre*s in manprocessing plants to more effecti el clean and saniti'e production lines and t&eequipment$ Older equipment and utensils t&at come into direct contact *it& products&ould e assessed routinel $ Samples s&ould e ta6en after cleaning and eforesaniti'ation *&en equipment is disassem led to its furt&est points$ 1&is isparticularl important for t&e production of coo6ed, read 3to3eat products in t&epost3let&alit en ironment of t&e plant *&ere it is e8tremel important to loo6 for&ar orage sites *&ere Listeria ma e a le to gro*$

<or coo6ed, read 3to3eat products, it is criticall important t&at a plant’sen ironmental sampling program for t&e post3let&alit production area e alidatedto demonstrate t&at t&e testing frequenc is sufficient to control Listeria. 1&e 7oneconcept discussed a o e is commonl used as part of t&e program along *it&correcti e actions to e ta6en if Listeria is detected on direct food contact surfaces orin t&e en ironment around food contact surfaces$

A properl designed and implemented en ironmental monitoring program *illgreatl increase management’s understanding of its food safet s stem and confirmt&at procedures in place are in fact effecti e in reducing t&e ris6 of micro ialcontamination of product$ +t *ill also &ig&lig&t areas *&ere impro ements ma enecessar to impro e ot& product safet and qualit $