21.4 Documentation...
Effectivedocumentation is an essentialand integral part of GMP and, in
particular,one of the essentialfeatures of a properly operated HACCP system.
The purposes of documentationare to definethe policies,materials, operations,
activities,controlmeasures and products; to recordand communicateinforma-
tionneeded before, duringor aftermanufacture;to reduce the risk of error
arising fromoralcommunication;and to forma vitalpartof the audit trail
necessaryfor tracing the historyof the componentsusedto produce the final
product. The system of documentationshouldensurethat,as far as is practic-
able, the history of eachbatch of product,includingutilisationand disposal of
raw materials, intermediatesand bulkor finished products, can be ascertained.
Documentsfall into fourmainclasses, namely, those settingout policies;
those settingout requirements,instructionsand procedures;those settingout
programmesto be carried out in particularperiods;and thoserequiring datato
be enteredbefore,duringand aftermanufacture to provide a record of whathas
happened. Failure to maintain appropriate documentation and records will
nullify many of the benefitsof GMP.
21.5 Premises,equipment,productand processdesign
Buildingsshould be located, designed,constructed, adaptedand maintained to
suit the operations carriedout in themand to facilitate the protection of materials
and products from deterioration, contamination or cross-contamination.
Equipmentshouldbe designed,constructed, adapted,locatedand maintained
to suit the processes and products for whichit is used;to facilitateprotection of
the materials handled or the resulting productsfrom contamination, cross-
contamination or deterioration;and to facilitateeffectivecleaning.
GMP relatesnot onlyto products and processes thatalreadyexist. The
developmentof a newproductor a newprocess,or a significantchangeto an
existing product or process,providesthe opportunity to optimisein respect of
GMP. Products and processes should be so designedas to ensure that the end-
product meets consumer expectation within the intended and anticipated
duration and circumstances of use,and to ensure that productdesign and
performancehave beenfullyevaluatedfor the required function in respectof
microbiological safety,chemicalsafety, physical safetyand sensory quality. To
this end,the valueof the multidisciplinaryhazard analysistechniqueusually
known as Hazard Analysis Operability Studies (HAZOP) is emphasised,
preferablyappliedfromthe earlieststagesof productand process development
witha viewto eliminating or minimisingpotentialhazardswherever possible
and incorporating effectivecontrolparameters intothe product and process
design.
Similar considerationsapplywhere changes are made thatwould affect
integrity, safetyor stabilityof a product. Suchchangescouldincludethosemade
to ingredients, formulation or recipe, operations, machinery, processes or330 Handbookof hygiene controlin the foodindustry