E whakamārama ana a Eduard Marty o Codols, he āhuatanga hoahoa motuhake kei ngā taputapu rongoā me ngā taputapu horoi taiwhanga me mōhio ngā kaihanga ki ēnei āhuatanga kia tutuki ai ngā whakaritenga.
He tino pakari ngā paerewa e whaihia ana e ngā kaihanga taputapu ina hoahoa ana, e hanga ana hoki i ngā mīhini horoi mō te umanga rongoā. He mea nui tēnei hoahoa nā te mea he maha ngā āhuatanga e whakaratohia ana hei whakatutuki i ngā Tikanga Hanga Pai (taputapu GMP) me ngā Tikanga Taiwhanga Pai (taputapu GLP).
Hei wāhanga o te whakapūmau kounga, me whakarite e te GMP kia hangaia ngā hua i roto i te huarahi ōrite me te whakahaere kia rite ki ngā paerewa kounga e tika ana mō te whakamahinga o te hua, i raro hoki i ngā tikanga e tika ana mō te hokohoko. Me whakahaere e te kaihanga ngā āhuatanga katoa ka pā ki te kounga whakamutunga o te hua rongoā, me te whāinga matua kia whakaitihia te mōrearea i roto i te hanga o te hua rongoā katoa.
He mea whakahau ngā ture GMP mō ngā kaihanga rongoā katoa. Mō ngā taputapu GMP, he whāinga motuhake anō tā te tukanga:
He rerekē ngā momo tukanga horoi: ā-ringa, ā-tūnga (CIP) me ngā taputapu motuhake. E whakarite ana tēnei tuhinga i te horoi ā-ringa ki te horoi me ngā taputapu GMP.
Ahakoa he maha ngā āhuatanga o te horoi ringa, he maha ngā raruraru pērā i te roa o te wā horoi, te nui o ngā utu tiaki, me te uaua ki te whakamātautau anō.
Me whai haumitanga tuatahi te mīhini horoi kakahu GMP, engari ko te painga o te taputapu he ngāwari ki te whakamātautau, ā, he tukanga tāruarua, he whai tohu hoki mō tētahi taputapu, mōkihi me tētahi wāhanga. Mā ēnei āhuatanga ka taea e koe te whakapai ake i te horoi, me te penapena wā me te moni.
E whakamahia ana ngā pūnaha horoi aunoa i roto i ngā whare rangahau me ngā whare hanga rongoā hei horoi i te tini o ngā taonga. Ka whakamahia e ngā mīhini horoi te wai, te hopi horoi me te mahi miihini hei horoi i ngā mata mai i ngā para taiwhanga me ngā wāhanga ahumahi.
I te whānuitanga o ngā mīhini horoi kakahu mō ngā mahi rerekē kei te mākete, he maha ngā pātai ka ara ake: He aha te mīhini horoi kakahu GMP? Āhea me horoi ā-ringa, ā, āhea me horoi GMP? He aha te rerekētanga i waenga i ngā gasket GMP me te GLP?
Ko te Taitara 21, Ngā Wāhanga 211 me te 212 o te Ture Whakahaere ā-Motu (CFR) o te US Food and Drug Administration e whakamārama ana i te anga ture e pā ana ki te hanganga ture GMP mō ngā rongoā. Kei roto i te Wāhanga D o te Wāhanga 211 e rima ngā wāhanga mō ngā taputapu me ngā mīhini, tae atu ki ngā gaskets.
Me whai whakaaro anō hoki ki te Wāhanga 11 o te 21 CFR e pā ana ki te whakamahinga o ngā hangarau hiko. E rua ngā wāhanga matua: te rēhitatanga hiko me te waitohu hiko.
Me tutuki hoki ngā ture a te FDA mō te hoahoa me te hanga i ngā taputapu ki ngā aratohu e whai ake nei:
Ka taea te wehewehe i ngā rerekētanga i waenga i ngā mīhini horoi GMP me GLP ki ētahi āhuatanga, engari ko ngā mea tino nui ko te hoahoa mīhini, te tuhinga, tae atu ki te pūmanawa, te aunoatanga me te whakahaere tukanga. Tirohia te ripanga.
Mō te whakamahinga tika, me tika te tohu i ngā horoi GMP, me te karo i ngā whakaritenga teitei ake, i ngā mea rānei kāore e tutuki i ngā paerewa ture. Nō reira, he mea nui kia whakaratohia he Whakatakotoranga Whakaritenga Kaiwhakamahi (URS) e tika ana mō ia kaupapa.
Me whakaahua ngā paerewa hei whakatutuki i roto i ngā whakatakotoranga, te hoahoa mīhini, ngā mana whakahaere tukanga, ngā pūmanawa me ngā pūnaha whakahaere, me ngā tuhinga e hiahiatia ana. E hiahiatia ana e ngā aratohu GMP kia whakahaerehia e ngā kamupene he aromatawai mōrearea hei āwhina i te tautuhi i ngā mīhini horoi e tika ana hei whakatutuki i ngā whakaritenga kua tohua.
Ngā Pakitara GMP: Kua whakaaetia e te FDA ngā wāhanga katoa o te hononga rawhi, ā, ko ngā paipa katoa he AISI 316L, ā, ka taea te tango wai. Whakaratohia te hoahoa waea taputapu me te hanganga katoa e ai ki te GAMP5. Ko ngā taraka, ngā whata rānei o roto o te mīhini horoi GMP kua hangaia mō ngā momo wāhanga tukanga katoa, arā, ngā taputapu, ngā tāke, ngā ipu, ngā wāhanga raina pounamu, te karāhe, me ētahi atu.
Ngā Pakitara GPL: I hangaia mai i te huinga o ngā wāhanga paerewa kua whakaaetia, ngā paipa pakari me ngā paipa ngāwari, ngā miro me ngā momo pakitara rerekē. Kāore e taea te tango wai i ngā paipa katoa, ā, kāore hoki ō rātou hoahoa e tutuki i ngā whakaritenga GAMP 5. Kua hangaia te taraka horoi o roto o te GLP mō ngā momo rauemi taiwhanga katoa.
Ka rongoa e tēnei paetukutuku ngā raraunga pēnei i ngā pihikete mō te mahi a te paetukutuku, tae atu ki ngā tātaritanga me te whakawhaiaro. Mā te whakamahi i tēnei pae, e whakaae aunoa ana koe ki tā mātou whakamahinga o ngā pihikete.