Finally, thereis no section headed `FoodHygiene' in this chapterbecause
GMP does not treat food hygieneas a compartmentalised topic but as a
continuous thread underlyingevery aspect.
21.2 Effectivemanufacturingoperationsand foodcontrol
Everyaspectof the manufacturingoperationmustbe properlyspecifiedin advance
and systematicallyreviewed regularly,including all resources andfacilities,
premisesand space,equipment,trainedpeople,raw materials,packagingmaterials,
storage,transport,operatingprocedures,cleaningprocedures,establishmentof
criticalcontrolpoints,managementand supervision,and services(see Table21.2).
And,criticallyimportant,thesemustbe providedin the rightquantities,at the right
timesand places;and the thoroughnessand effectivenessof theiruse mustbe
regularlymonitored.
To ensure that manufacturingoperationsgo according to planit is essential
that:
∑ relevant written proceduresare providedto operators,in instructionalform
and in clearand unambiguouslanguage,and are specifically applicableto the
facilities provided;
∑ operators are trainedto carryout the procedurescorrectly;
∑ recordsare made(whethermanuallyor by recordinginstruments or both)
during all stages of manufacture, which demonstrate that all the steps
required by the definedprocedures werein fact carriedout, and that the
quantityand qualityproducedwerethose expected;
∑ a traceabilitysystemis in placeto identify and trackall inputs into,and
outputsfrom,the manufacturingprocess;
∑ recordsare madeand retained in legible and accessible formto enable the
historyof the manufacture and distributionof a batchto be traced;
Table21.2 Effectivemanufacturingoperations
Everyaspectof manufacturefullyspecifiedin advance;all resourcesand facilities
specified,namely:
∑ measuresand precautionsat CriticalControlPointsbasedon hazardanalysis
∑ adequatepremisesand space
∑ correctand adequatelymaintainedequipment
∑ appropriatelytrainedpeople
∑ correctraw materialsand packagingmaterials
∑ appropriatestorageand transportfacilities
∑ writtenoperationalproceduresand cleaningschedules
∑ appropriatemanagementand supervision
∑ adequatetechnical,administrativeand maintenanceservices
Goodmanufacturing practice(GMP)in the foodindustry 327