Foreword

The quality of drugs course looks at the quality assurance of pharmaceuticals thus the

activities and responsibilities that are necessary for ensuring that the medicines supplied to

patients are safe, effective and acceptable to the users. Furthermore, the course also looks

at the methods that are used in the sampling, specifications, testing of pharmaceuticals

including the methods and procedures that are followed to ensure that all the necessary

tests are conducted in the pharmaceuticals prior their distribution to the market. Listed

below are the key definitions that the students will have to familiarize themselves with for

this course.

Key definitions

Active pharmaceutical ingredients: a chemical substance used in the manufacturing of

pharmaceuticals, pharmaceutical product and is responsible for its biological activity.

Excipients: a substance formulated alongside the active pharmaceutical ingredient (API)

that has been evaluated for safety and is key in the delivery of the API.

Stability: the ability of a pharmaceutical to maintain its physical, chemical, therapeutic and

microbial properties during the time of storage and usage.

Shelf-life: the time period from the date of manufacture that a pharmaceutical product is

expected to remain within the approved specification while stored underdefined conditions.

Impurities: undesirable substances that remain with the API and differ in chemical

composition

Uniformity: consistency of colour, shape and size.

Potency: the amount of the pharmaceutical required to induce an effect of a given or

required intensity. Usually 90-110% of the labelled amount.

Precision: how well-repeated measurements of the same quantity agree.

Accuracy: the extent to which a measurement represents the true value of that which is

being measured.

Calibration: a process that demonstrates that a particular instrument produces desired

results within the specified limits.

Melting point: the temperature at which a particular substance is completely melted as

indicated by the disappearance of the solid in the range of ± 4°C from the stated value.

Boiling point: the temperature at which the vapour pressure of a liquid equals the external

pressure surrounding the liquid.

Solubility: maximum concentration of a substance that may be completely dissolved in a

given solvent at a given temperature and pressure.

Buffer: a solution that resists changes in pH upon the addition of small amounts of acid or

bases or upon dilution. In pharmaceutical products, these are used to adjust the pH of the

product for maximum stability and to maintain the pH within the optimum physiological pH

range.

Titration: a technique where an unknown solution of known concentration is used to

determine the concentration of an unknown solution.

Direct titration: the direct volumetric analysis of the unknown concentrations in the

titration flask with a titrant of known concentration being added from a burette.
Back titration: a known excess of standard reagent is added to the solution and the excess is

titrated/ the concentration of an analyte is determined by reacting it with a known amount

of excess reagent.

Standardization: the process of determining the exact concentration (molarity) of a solution

Point of equivalence: the volume of titrant at which the number of moles of titrant is equal

to the number of moles of an analyte/ the point at which chemically equivalent quantities of

reactants have been mixed.

Acid value: the mass of potassium hydroxide (in mg) required to fully titrate an acid in one

gram of a sample.

Saponification: a process by which triglycerides are reacted with sodium or potassium

hydroxide to produce glycerol and a fatty acid salt / convert into soap by hydrolizing an

ester into an acid and alcohol as a result of treating it with an alkali

Saponification value: the mass of potassium hydroxide required to saponify a fatty acid in

one gram of a sample.

Bulk product: any material that has undergone all the processing stages excluding final

packaging.

Batch/lot: a defined quantity of material that is processed in a single or a series of

processes with the expectation that it will be homogenous at the end of processing.

Batch/lot number: a unique number or a combination of numbers used to identify a

specific batch on the label and the corresponding certificates for analysis.
Contamination: an undesired introduction of impurities of either microbial or chemical

nature into either the final, intermediate or the starting material used during production.

Cross-contamination: contamination of either the final, intermediate or the starting

material with another material during the process of production.

Critical operation: an operation in the manufacturing process that may cause variation in

the quality of the pharmaceutical product.

Clean/sterile area: a defined environmental control of particulate matter or

microorganisms where either manufacturing or processing of material occurs, to minimize

the introduction of contaminants.

Packaging: all the operations that a bulk product has to go through to become a finished

product.

Packaging material: any material used in the packaging of a finished product excluding the

material used for outer packaging during transportation.

Validation: proving according to good manufacturing practice principles that the

procedure, process, equipment, material, activity or system lads to the expected results.

Standard operating procedure (SOP): an authoritative written procedure which outlines

the instructions to be followed for a given product, material or service, eg cleaning,

equipment maintenance, sampling and inspection.

References
World Health Organisation. Quality assurance of pharmaceuticals: A compendium of

guidelines and related materials. Good manufacturing practices and inspection. Volume: 1,

Switzerland: World Health Organization; 1997.

World Health Organisation. Quality assurance of pharmaceuticals: A compendium of

guidelines and related materials. Good manufacturing practices and inspection. Volume: 2,

Switzerland: World Health Organization; 2007.

Intshayelelo (IsiXhosa)

Izifundo zomgangatho wamachiza zijonga ukuqinisekiswa komgangatho wemveliso

zamachiza, imisebenzi kunye noxanduva oluhambelana nokuqinisekisa ukuba amayeza

anikezwa izigulana akhuselekile, ayasebenza kwaye ayamkeleka kubasebenzisi bawo.

Ngapha koko, ezizifundo zikwajonga iindlela ekuthatyathwa ngayo isampuli, ukucaciswa,

ukuvavanywa kwamachiza kunye nazo zonke indlela ezilandelwayo ukuqinisekisa ukuba

zonke iimvavanyo eziyimfuneko ziyenziwa kumachiza ngaphambi kokuba asiwe kwimarike.

Apha ngezantsi kudweliswe iinkcazo eziphambili ekufuneka abafundi baziqhelanise nazo

kwezizifundo.

Iinkcazo eziphambili

Isithako esisebenzayo samachiza: ikhemikhali esetyenziswa ekwenzeni amachiza,

kwimveliso yamachiza kwaye inendima eyidlalayo kumsebenzi webhayoloji.

Abafuduki: into eyenziwa nesithako esisebenzayo samachiza evavanyelwe ukhuseleko

kwaye ibalukeli ekuhanjisweni kwesithako sechiza.

Uzinzo: isimo sokugcina imeko yenkangeleko, yonyango kunye neyeentsholongwane

ngexesha lokugcinwa nokusetyezwisa kwechiza.

Ubomi beshelf: ixesha elisusela kumhla wokwenziwa kwechiza ekulindeleke ukuba lihlale

ngaphakathi kwenkcazelo evinyiweyo ngelixa igcinwe phantsi kwemeko ezichazwe

kokucacileyo.

Ukungcola: izinto ezingafunekiyo ezisele zihlala ne API kwaye zahlukile ngokwakhiwa

kwekhemikhali.
Ukufana: ukungqinelana kombala, ukwakheka kunye nobungakanani bechiza.

Amandla: inani leyeza elifunekayo ukunikeza iziphumo ezifunekayo okanye ezonelisayo.

Ngokwesiqhelo liba-90-110% kwixabiso elibhaliweyo.

Ukuthingqo: indlela imilinganiselo ephindaphindiweyo kakuhle yamanani afanayo

avumelana.

Ukuchaneka: indlela umlinganiso obonasi ngayo ukuba inani elithelekiswayo lifana

kakanganani kweliyinyani.

Isiqinisekiso: inkqubo ebonisa ukuba isixhobo esithile sivelisa iziphumo ezifunwayo

ngaphakathi kwemida echaziweyo.

Ukunyibilika: iqondo lobushushu apho into ethile inyibilikisiwa ngokupheleleyo njengoko

kubonisiwe ngokunyamalala kwesiseko kuluhlu lwe ± 4 ° C kwixabiso elichaziweyo.

Ukubila: ubushushu apho uxinzelelo lwento yokufuma yolwelo lulingana noxinzelelo

lwangaphandle olujikeleze ulwelo.

Ukunyibilika: ubuninzi bokuxinzelelwa kwento enokunyibilika ngokupheleleyo

kwisinyibilikisi esithile phantsi kwamaqondo athile kunye nonxizelelo.

I-Buffer: isisolmbululo esichaseneyo neguqu kwi-pH eyenzeka xa kongezwa I aside okanye

isiseko. Xa kusenziwa amayeza, isetyenziswa ukulingisa ipH yeyeza ukuba izinze kwaye

nokugcina ipH ngaphakathi koluhlu lwepH olulungileyo.

I-Titration: ubuchule bokusebenzisa isisombululo esingaziwayo soxinzelelo olwaziwao

ukufumana uxinzelelo lwesisombululo esingaziwayo.

I-Direct-titration: uhlalutyo ngqo lomthamo wezinto ezingagxilwanga kwigumbi lokugcina

kunye nesisitho sokuxinzezeleka okwaziwayo songezwa kwindawo yobambiso.

I-Back titration: uxinzelelo lomhlalutyo lujongwa ngokulithelekisa kunye nenani elaziwayo

lesenzi esigcwele okugqithisileyo.

Umgangatho: ukumisela ngqo uxinzelelo (molarity) wesisombululo.

Inqaku lokulingana: indawo apho umxube we-khemikhali ulinganayo.

Ixabiso le-asidi: isikalo se-potassium hydroxide (mg) esifunekayo ukukhupha

ngokupheleleyo iasidi kwigram enye yesampula.

Saponification: ukwenza isepha ngokufaka ihydrogen kwi-ester yenze I aside notywala

ngenxa yokunyangwa nge-Alkali

Saponification value: ubunzima be potassium hydroxide efunekayo ukukhupha i-acid

enamafutha kwigram enye yesampulu.

Imvelisi eninzi: zonke izixhobo eziwahambe onke amanqanaba wokwenziwa ngaphandle

kokupakishwa okusekugqibeleni.
Isipha: ubungakanani obuchaziweyo bezinto ezibonakalayo ezenziwa kwinkqubo enye

okanye zothotho lweenkqubo ngokulindelekileyo ukuba iyakuba yinto eyodwa emva

kokugqitywa.

Inombolo yesipha: inombolo eyahlukileyo okanye indibaniselwano yamanani

esetyenzisiweyo ukuchonga isipha esithile kwileyibhile kunye nezatifikethi ezihambelanayo

zohlalutyo.

Ungcoliso: ukufakwa kwesingcolisi esingafunekiyo esiyintsholongwane okanye ikhemikhali

ekugqibeleni, phakathi okanye ekuqaleni kwenkqubo yemveliso.

Ungcoliseko: ukungcoliseka kwemvelisoo kanye kwezinto ezisekuqgibeleni, phakathi okanye

ekuqaleni kwenkqubo yemveliso.

Umsebenzi obalulekileyo: umsebenzi kwinkqubo yokuvelisa enokubangela ukwahluka

kumgangatho wemveliso yamachiza.

Indawo engenazintsholongwana: ulawulo lwendawo engqongiweyo apho kusenziwa knona

imvelisoukwehlisa ukungena kwezinto okanye iintsholongwane ezinokungcolisa.

Ukupakisha: wonke umsebenzi ekumele wenziwe kwimvelsio ukuze imvelsio ibe igqityiwe.

Izinto zokupakisha: yonke into esetyizwiswa ekupakisheni imveliso ngaphandle kwezinto

ezisetyenziselwa ukupakisha imveliso xa izakuhanjiswa.

Uqinisekiso: ukubonisa ngokwemigaqo elungileyo yemveliso ukuba inkqubo, izixhobo,

izinto, umsebenzi okanye inkqubo ikhupha iziphumo ezilindelekileyo.

Inkqubo eqhelekileyo yokusebenza: inkqubo ebhaliweyo njengegunya echaza imiyalelo

emayilandelwe kwinkqubo yemveliso okanye kwinkonzo, umzekelo, ukucocwa, ulondolozo

lwezixhobo, ukuqokelela isampulu kunye nokuhlolwa.

References

World Health Organisation. Quality assurance of pharmaceuticals: A compendium of

guidelines and related materials. Good manufacturing practices and inspection. Volume: 1,

Switzerland: World Health Organization; 1997.

World Health Organisation. Quality assurance of pharmaceuticals: A compendium of

guidelines and related materials. Good manufacturing practices and inspection. Volume: 2,

Switzerland: World Health Organization; 2007.

Isandulela (IsiZulu)

Izinga lekhosi yezidakamizwa libheka ukuqinisekiswa kwekhwalithi yemithi, ngakho ke

imisebenzi nezibopho ezidingekayo zokuqinisekisa ukuthi umuthi onikwezwa iziguli

uphephile, uyasebenza futhi uyamukeleka kubasebenzisi. Ngaphezu kalokho, isifundo

sibheka nezindlela ezisetshenziswela isampula, ukucaciswa, ukuhlowa kwemithi

kubandakanya nezindlela nezinqubo ezilandelwayo ukuze kuqinisekiswe ukuthi zonke

izivivinyo ezidingekayo zenziwa emithini yezemithi ngaphambi kokuhanjiswa kwazo

emakethe. Okubalwe ngezansi izincazelo ezibalulekile abafundi kuzofanela bazijwayeze

ngalezi zifundo.

Izincazelo ezimqoka

Izithako ezisebenza ngemithi: into yamakhemikhali esetshenziselwa ukwenziwa kwemithi,

umkhiqizo wemithi futhi inesibopho somsebenzi wayo wezinto eziphilayo.

Abahambeli: into eyakhiwe eceleni kwesithako esisebenzayo semithi (API) esihlolwe

ukuphepha futhi siyisihluthulelo ekulethweni kwe-API.

Ukusimama: amandla emithi yokugcina izakhiwo zayo zomzimba, zamakhemikhali,

zokwelapha kanye nezinto ezincane ngesikhathi sokugcinwa nokusetshenziswa.

Impilo yeshelf: isikhathi esivela osukwini lokukhiqizwa lapho umkhiqizo womkhiqizo

kulindeleke ukuthi uhlale ngaphakathi kwencazelo evunyiwe ngenkathi ugcinwa ngaphansi

kwezimo ezichaziwe.

Ukungcola: izinto ezingafuneki ezisele ne-API futhi zihlukile nokwakhiwa kwamakhemikhali.

Ukufana: ukuvumelana kombala, ukwakheka nobukhulu.

I-potency: inani lemithi edingekayo ukuthonya umphumela wokuqina noma kokudingekayo.

Imvamisa ngu 90-110% wenani elibhalwe phansi.

Ukuqonda: ukuthi izilinganiso eziphindaphindwa kahle zenani elifanayo ziyavumelana

kanjani.

Ukunemba: isilinganiso lapho sibonisa inani leqiniso lalokho elikulingwayo.

Ukulinganisa: inqubo ekhombisa ukuthi ithuluzi elithile likhiqiza imiphumela efiselekayo

ngaphakathi kwemikhawulo ebekiwe.

Ukuncibilika: izinga lokushisa lapho into ethile incibilike ngokuphelele njengoba

kukhonjiswa ngokunyamalala kwesiqalo ebangeni le-± 4 ° C kunani elishiwo.

Ukubila: izinga lokushisa lapho umfutho we-vapor wetshezi ulingana nengcindezi

yangaphandle ezungeze uketshezi.

I-solubility: ubukhulu bokuphakama kwento engahlakazeka ngokuphelele endaweni

yokuqothula enikezwe ekushiseni okucindezelwe kanye nengcindezi.

I-buffer: isixazululo esinqanda izinguquko ku-pH phezu kokufakwa kwamanani amancane

we-acid noma izisekelo noma i-dilution. Emikhiqizweni yemithi, lokhu kusetshenziselwa

ukulungisa i-pH yomkhiqizo ukuze kube nokuqina okukhulu kanye nokugcina i-pH

ngaphakathi kohlu lwe-pH oluhle kakhulu.

I-titration: inqubo lapho kutholakala khona isixazululo esingaziwa sokuhlushwa esaziwayo

ukuthola ukunqampulwa kwekhambi okungaziwa.

I-direct translation: ukuhlaziywa okuqondile kwe-volumetric kokugxila okungaziwa

kuflaskation ye-titration ene-titrate yokuhlushwa okwaziwayo kufakwa ku-Burette.

I-back titration: ukungezelela okwaziwayo kwe-reagent ejwayelekile kufakwa kwizixazululo

futhi okuthe xaxa kukalwa / ukuqoqwa komhlaziyi kunqunywa ngokukuphendula ngenani

elaziwayo le-reagent ngokweqile.

Ukumisa: inqubo yokuthola iqoqeme ngqo (i-molarity) yesisombululo.

Iphuzu lokulingana: umthamo wokukhipha lapho inani lama-moles of titrant lilingana

nenani lama-moles womhlaziyi.

Inani le-acid: isisindo se-potassium hydroxide (in mg) esidingekayo ukufaka i-acid

ngokuphelele kugremu eyodwa yesampula.

I-saponification: ukushintsha ube insipho ngokufaka i-hydrate i-ester ibe yi-acid kanye

notshwala ngenxa yokuyiphatha nge-alkali.

Inani lesaponification: isisindo se-potassium hydroxide esidingekayo ukuze kufafazwe i-acid

enamafutha kwigremu eyodwa yesampula.

Umkhiqizo ngobuningi: noma yikuphi okusetshenziswe kuzo zonke izigaba zokucubungula

ngaphandle kokufakwa kokugcina.

I-batch: inani elichaziwe lezinto ezisetshenziswayo ngendlela eyodwa noma uchungechunge

lwezinqubo ngethemba lokuthi luzosebenza homo native ekugcineni kokucutshungulwa.

Inombolo ye-batch: inombolo ehlukile noma inhlanganisela yezinombolo esetshenziselwa

ukukhomba ibatch ethile kwilebula nezitifiketi ezihambisanayo zokuhlaziywa.

Ukungcola: ukwethulwa okungafuneki kokungcoliswa kwemvelo yesibonakhulu noma

yamakhemikhali kokunye, kokuphakathi noma kokuqala okusetshenziswe ngenkathi

kukhiqizwa.

Ungcoliseko: ukungcoliswa kokuqukethwe kokugcina, kokuphakathi noma kokuqala ngenye

impahla ngesikhathi senqubo yokukhiqiza.

Ukusebenza okubucayi: ukusebenza kwinqubo yokukhiqiza engadala ukwahluka

kwikhwalithi yomkhiqizo wemithi.

Indawo ehlanzekile / oyinyumba: ukulawulwa okuchaziwe kwemvelo kwento yezinto

eziyizakhi noma ama-microorganisms lapho kukhiqizwa noma kusetshenziselwa izinto

okwenzeka khona, ukunciphisa ukwethulwa kokungcola.

Ukupakisha: yonke imisebenzi okumele yenziwe ngumkhiqizo omningi ukuze ube umkhiqizo

osuqediwe.

Izinto zokupakisha: noma yikuphi okusetshenziselwa ukufakwa komkhiqizo kuqediwe

ngaphandle kwezinto ezisetshenziselwa ukufakwa kwangaphandle ngesikhathi sokuhamba .

Ukuqinisekiswa: kufakazela ngokuya ngemigomo yokwenza okuhle yokukhiqiza ukuthi

inqubo, inqubo, izinto zokusebenza, izinto ezibonakalayo, umsebenzi noma amasheya

wesistimu emiphumeleni elindelekile.

Inqubo ejwayelekile yokusebenza (SOP): inqubo ebhaliwe egunyaza imiyalo okufanele

ilandelwe yomkhiqizo onikiwe, okokusebenza noma kwensizakalo, isib. ukuhlanza,

ukugcinwa kwemishini, amasampula kanye nokuhlolwa.

Voorwoord

Die gehaalte van die narkotiese kursus kyk na die kwaliteit versekering van farmaseutiese

produkte deur die aktiwiteite en verantwoordlikhede wat belangrik is vir die versekering,

dat die medisyne wat aan pasiente verskafword, veilig effektief en aanvaarbaar vir die

gebruiker is. Vervolgens, die kursus kyk ook na die metodes van steekproefneming ,

spesifikasies, toetsing van farmaseutiese middels insluitend die metodes en prosedures

watgevolg word om te verseker dat al die nodige toetse gedoen en deurgevoer is voordat

die verspreiding op die mark plaasvind. Die onderstaande lys is die sleuteldefinisies

waarmee die studente hulle moet vergewis gedurende die kurses.

Sleuteldefinisies

Aktiewe farmaseutiese bestandele: ‘n Chemiese bestandeel wat gebruik word in die

vervaardiging van die farmaseutiese produkte en die verantwoordlike biologiese strekking.

Bystowwe: ‘n Chemiese stof wat gebruik word om met die aktiewe farmaseutiese

bestandeel te werk wat ge -evalueer is vir veiligheid en doeltreffendheid en wat met die

farmaseutiese bestandeel kan saamwerk.

Stabiliteit: Die vermoë van die farmaseutiese bestandeel om die fisiese, chemiese,

terapeutiese en mikrobiese eienskappe te behou tydings storing en gebruik.

Raklewe: Die periode vanaf die datum van vervardiging wat van ‘n farmaseutiese produk

verlang word om binne die voorgeskrewe spesifikasies te bly terwyl dit onder voorgeskrewe

toestande gestoor word.

Onsuiwerhede: Ongewenste stowwe wat bly in die aktiewe farmaseutiese bestandeel en

verskil van die chemiese samestelling.

Uniformiteit: Konstante verhouding van kleur, vorm en groote.

Sterkte: Die hoeveelheid van die aktiewe farmaseutiese bestandeel wat vereis word om die nidige

uitwerking te gee of die vereiste intensiteit tot gevolg te hê. Gewoonlik 90%-110% van die

voorgeskrewe totaal.

Presiesie: Hoe goed herhaalde voorgeskrewe toediening van dieselfde hoeveelheid saam stem.

Akuraatheid: Die mate waarvolgens ‘n meting die ware waarde van die meting verteenwoordig van

dit wat gemeet is.

Kalibrasie: ‘n Proses wat demonstreer dat ‘n spesifieke instrument die verwagte lesing sal gee binne

spesifieke perke.

Smeltpunt: Die tempratuur waarteen ‘n spesifieke stof totaal smelt soos aangedui by die smelting

van ‘n vastestof in die waarde van ± 4°C van voorgeskrewe waarde.

Kookpunt: Dit is die tempratuur waar die dampdruk van ‘n vloeistof gelykstaande is aan die eksterne

druk rondom die vloeistof.

Oplosbaarheid: Die maksimum konsentrasie van ‘n stof wat heeltemal opgelos mag word in ‘n

gegewe oplosmiddel teen ‘n gegewe tempratuur en druk.

Buffer: ‘n Oplossing wat verandering teenstaan onder die pH deur die byvoeging van ‘n klein

hoeveelhede suur of basis of tydens verdinning. In farmaseutiese produkte, word dit aangewend om

die suurgehalte (pH) van die produk vir maksimum stabiliteit aan te pas en om die pH (suurgehalte)

te behou binne die optimale fisiologiese pH waarde.

Titrasie: ‘n Tegniek waar ‘n onbekende oplosing van ‘n onbekende konsentrasie gebruik word om die

konsentrasie van die onbekende oplossing te bepaal.

Direkte titrasie: Die direkte volumatriese analise van ‘n onbekkende konsentrasie in die titrasie

beker meet ‘n titrant of bekende konsentrasie wat bygevoeg word met ‘n buret.

Terug titrasie: ‘n Bekende oorskot van standaard reageermiddel word bygevoeg by die oplossing en

die oorskot word titreer.

Standaardisering: Die proses van bepaling van die korrekte konsentrasie (molariteit) van ‘n

oplossing.

Punt van ekwivalensie: Die volume van die titrant waar die aantal mol titrant gelykstaande is aan die

aantal mol van die analiet.

Suurwaarde: Die massa van kaliumhidroksied (in mg) wat benodig word om ‘n volle titraat van suur

in een gram monster te verwerk.

Verseping: ‘n Proses waarby trigliseriede reageer met sodium of kaliumhidroksied om gliserol en ‘n

vetsuur sout to produseer.

Versepingwaarde: Die massa van kaliumhidroksied wat benodig word om n vetsuur te verseep in

een gram monster.

Grootmaatproduk: Enige materiaal wat al die vervaardigings prosesse ondergaan het, maar waar die

finale verpakking uitgesluit word.

Groep: ‘n Verklaarde hoeveelheid materiaal wat geprosesseer word in 'n enkele of 'n reeks prosesse

met die verwagting dat dit aan die einde van die verwerking homogeen sal wees.

Groep/lot nommer: 'n Unieke nommer of 'n kombinasie van getalle wat gebruik word om 'n

spesifieke groep op die etiket te identifiseer en die ooreenstemmende sertifikate vir ontleding.

Besoedeling: 'n Ongewenste toevoeging van onsuiwerhede van mikrobiese of chemiese aard in óf

die finale, intermediêre of die beginmateriaal wat tydens produksie gebruik word.

Kruiskontaminasie: Kontaminasie van of die finale, intermediêre of die beginmateriaal met 'n ander

materiaal tydens die produksieproses.

Kritieke werking: 'n Operasie in die vervaardigingsproses wat die kwaliteit van die farmaseutiese

produk kan verander.

Skoon / steriele area: 'n Gedefinieerde omgewingsbeheer van deeltjies of mikro-organismes waar

vervaardiging of verwerking van materiaal plaasvind, om die toediening van kontaminante tot die

minimum te beperk.

Verpakking: al die bewerkings wat 'n grootmaatproduk moet deurmaak om 'n finale produk te word.
Verpakkingsmateriaal: materiaal wat gebruik word in die verpakking van 'n finale produk,

uitgesonderd die materiaal wat tydens buiteverpakking gebruik word.

Validering: bewys volgens goeie vervaardigingspraktykbeginsels dat die prosedure, proses,

toerusting, materiaal, aktiwiteit of stelsel tot die verwagte resultate gepaard gaan.

Standaardbedieningsprosedure: 'n gesaghebbende skriftelike prosedure wat die instruksies vir 'n

gegewe produk, materiaal of diens, soos skoonmaak, instandhouding van toerusting,

monsterneming en inspeksie, uiteensit.

Verwysings

Wêreldgesondheidsorganisasie. Kwaliteitsversekering van farmaseutiese produkte: 'n samestelling

van riglyne en verwante materiale. Goeie vervaardigingspraktyke en inspeksie. Deel: 1, Switserland:

Wêreldgesondheidsorganisasie; 1997.

Wêreldgesondheidsorganisasie. Kwaliteitsversekering van farmaseutiese

produkte: 'n samestelling van riglyne en verwante materiale. Goeie

vervaardigingspraktyke en inspeksie. Deel: 2, Switserland:

Wêreldgesondheidsorganisasie; 2007.

References

World Health Organisation. Quality assurance of pharmaceuticals: A compendium of

guidelines and related materials. Good manufacturing practices and inspection. Volume: 1,

Switzerland: World Health Organization; 1997.

World Health Organisation. Quality assurance of pharmaceuticals: A compendium of

guidelines and related materials. Good manufacturing practices and inspection. Volume: 2,

Switzerland: World Health Organization; 2007.