Igumbi lokucoca libhekisa kwindawo enomoya ococekileyo apho ucoceko lomoya, ubushushu, ukufuma, uxinzelelo, ingxolo, kunye nezinye iiparamitha zilawulwa njengoko kufuneka.
Kubaigumbi lokucoca, ukugcina umgangatho wococeko olufanelekileyo kubalulekile kwaye kuyimfuneko kwimisebenzi yemveliso enxulumene negumbi elicocekileyo.
Ngokubanzi uyilo, ulwakhiwo, kunye nokusebenza kwegumbi lokucoca kufuneka kunciphise ukuphazamiseka kunye nefuthe lemeko engqongileyo kwindawo engaphakathi yegumbi lokucoca, kwayeulawulo umahluko woxinzeleloyeyona ndlela ibalulekileyo kunye neyona ndlela isebenzayo yokugcina inqanaba lokucoceka kwegumbi, ukunciphisa ukungcoliseka kwangaphandle, kunye nokuthintela ukungcoliseka komnqamlezo.
Injongo yokulawula ukuhlukana koxinzelelo kwindawo yokucoceka kukuqinisekisa ukuba xa igumbi lokucoca lisebenza ngokuqhelekileyo okanye ibhalansi yonakaliswe okwethutyana, umoya unokuhamba usuka kwindawo enococeko oluphezulu ukuya kwindawo enococeko oluphantsi ukwenzela ukuba ukucoceka kokucoca. igumbi aliyi kuphazanyiswa ngumoya ongcolileyo.
Igumbi elicocekileyo lokulawula uxinzelelo lokwahlukana likhonkco elibalulekileyo kuyilo lweinkqubo yokupholisa umoyayocweyo olucocekileyo lwefektri yamayeza, kunye nomlinganiselo obalulekileyo wokuqinisekisa ukucoceka kwendawo ecocekileyo.
Isahluko solawulo lokwahlukana koxinzelelo lwegumbi lokucoca "INkcazelo yoYilo lweGumbi leCleanroom" GB50073-2013 (emva koku kubhekiselwa kuyo ngokuthi "inkcazo yegumbi lokucoca") ibandakanya izinto ezintlanu, zonke ezizezolawulo lokwahlukana koxinzelelo lwegumbi lokucoca.
Inqaku le-16 le-"Good Production Practice for Drugs" (ehlaziywe ngo-2010) ifuna indawo ecocekileyo kufuneka ibe nesixhobo esibonisa ukuhluka koxinzelelo.
Ulawulo loxinzelelo oluhlukileyo lwegumbi lokucoca lwahlulwe ngamanyathelo amathathu:
1. Qinisekisa ukuhlukana koxinzelelo lwegumbi ngalinye elicocekileyo kwindawo ecocekileyo;
2. Bala umthamo womoya woxinzelelo oluhlukeneyo lwegumbi ngalinye elicocekileyo kwindawo ecocekileyo ukugcina uxinzelelo oluhlukeneyo;
3. Thatha amanyathelo obugcisa ukuqinisekisa umthamo womoya woxinzelelo oluhlukeneyo kunye nokugcina uxinzelelo oluqhubekayo lokuhlukana kwindawo ecocekileyo.
Ixesha lokuposa: Jul-26-2022