| I-Physical Performance Qualification (PPQ) • Kuzoboniswa ukuthi zonke izindlela zokwamukela ezishiwo ziyakwazi ukukhiqizwa kabusha kuyo yonke inqubo. Mangaki ama-run okufanele inqubo ye-PPQ isebenze? • Ukukhombisa ukukhiqizwa kabusha kwenqubo, okungenani ama-run ama-3 ayadingeka; • Uma imijikelezo enguhhafu emi-3 yaqhutshwa ngesikhathi senqubo ye-MPQ, kuzomele kwenziwe okungenani umgijimo owodwa owodwa onesikhathi sokuchayeka esigcwele. |
Amazinga Ayisethenjwa:
- ISO 11135:2014 (Ukuqinisekiswa kokuvalwa kwe-EO kwedivayisi yezokwelapha)
- Isiqondiso se-FDA (2007): Ukuqinisekiswa KobuNzalo Kwemikhiqizo Esenziwe Amagciwane
- I-EU GMP Annex 1 (2022): Izidingo zokuqinisekisa inqubo yokuvala inzalo.
Kuboniswa Kanjani Ukuphindaphinda?
| Cha. | Isinyathelo Sokucubungula | Into | Indlela |
|---|---|---|---|
| 1 | Ukubeka phansi isimo | Izinga lokushisa nokuswakama komthwalo ovalelwe inzalo kungaphakathi kwebanga elishiwo ekupheleni kokulungiswa kwangaphambilini | Linganisa ngaphakathi komthwalo |
| 2 | Iyalayisha | Umkhawulo wesikhathi phakathi kokuphela kombandela wangaphambili kanye nokuqala kokuvala inzalo kufanele ube phakathi kwebanga elishiwo | Qinisekisa idatha yesikhathi esirekhodiwe |
| + | ukuvala inzalo | I-Ethylene oxide (EO) yethulwa kusibulala-magciwane ngendlela yegesi | Linganisa izinga lokushisa lomjovo wegesi |
| 4 | ukuvala inzalo | Ukwenyuka kwengcindezi ngenxa yokujova igesi ye-EO kungaphakathi kwebanga elishiwo | Linganisa ingcindezi ngesikhathi sokujova igesi |
| Okuthengwa edolo | ukuvala inzalo | Ukugxiliswa kwegesi ye-EO ngaphakathi kwesibulala-magciwane kungaphakathi kwebanga elishiwo | Kala isitsha segesi ngaphambi/ngemuva komjovo bese ubala umehlukonoma ukulinganisa ngokuqondile ukugcwala kwegesi ngaphakathi kwegumbi |
| 6 | ukuvala inzalo | Izinga lokushisa lomkhiqizo ngaphakathi komthwalo lingaphakathi kwebanga elishiwo phakathi nesigaba sokuchayeka | Linganisa izinga lokushisa lomkhiqizo |
| Okuthengwa kwava + | Umoya | Izinga lokushisa lomkhiqizo ngaphakathi komthwalo lingaphakathi kwebanga elishiwo phakathi nesigaba sokungenisa umoya | Linganisa izinga lokushisa lomkhiqizo |
Lapho kuhlolwa ukwenziwa kokuhlolwa kwe-PPQ, izici ezilandelayo kufanele ziqashelwe:
• Ingabe inani lamazinga okushisa nomswakama liyahlangabezana nezidingo?
• Ingabe ama-probe (izinga lokushisa nomswakama) afakwe ngaphakathi kwamaphakheji alayishiwe futhi abekwe ezindaweni ezimbi kakhulu (izindawo okunzima kakhulu ukuvala amagciwane)?
• Ingabe izinga lokushisa lomkhiqizo lingaphakathi kwebanga elishiwo?
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