He aha te cGMP?
I whānau mai te GMP rongoā tuatahi o te ao i te United States i te tau 1963. Whai muri i ētahi whakahoutanga me te whakarei ake me te whakapai ake tonu e te US FDA, kua noho te cGMP (Current Good Manufacturing Practices) i te United States hei tētahi o ngā māngai o te hangarau matatau i roto i te mara GMP, e whai wāhi nui haere ana ki te whakamahinga haumaru me te whai hua o ngā rongoā puta noa i te ao. I whakapuakina tuatahitia e Haina te GMP rongoā ture i te tau 1988, ā, e toru ngā whakahoutanga kua mahia mai i te tau 1992, 1998, me te 2010, me whakapai tonu ēnei. I roto i ngā tau neke atu i te 20 o te whakatairanga i te mahi GMP rongoā i Haina, mai i te whakauru i te ariā o te GMP ki te whakatairanga i te tiwhikete GMP, kua tutuki ngā whakatutukitanga ā-wāhanga. Heoi, nā te tīmatanga tōmuri o te GMP i Haina, he maha ngā āhuatanga o te whakamahi miihini i te GMP, ā, kāore anō kia tino whakauruhia te tikanga o te GMP ki roto i te whakahaere whakaputa me te kounga tuturu.
Te whakawhanaketanga o te cGMP
Kei te "wāhanga tīmatanga" tonu ngā whakaritenga GMP o nāianei i Haina, ā, he whakaritenga ōkawa noa iho. Kia taea ai e ngā umanga Hainamana te uru atu ki te mākete o te ao me ā rātou hua, me whakarite e rātou tā rātou whakahaere whakaputa ki ngā paerewa o te ao kia mōhiotia ai te mākete. Ahakoa kāore anō te kāwanatanga o Haina kia whakahau i ngā kamupene rongoā kia whakatinanahia te cGMP, ehara tēnei i te kī kāore he hiahia nui mō Haina ki te whakatinana i te cGMP. Engari, ko te whakahaere i te tukanga whakaputa katoa e ai ki ngā paerewa cGMP he mea nui hei neke ki te ao whānui. He waimarie, i Haina i tēnei wā, kua mōhio ngā kamupene rongoā me ngā rautaki whanaketanga whakamua ki te hiranga mō te wā roa o tēnei ture, ā, kua whakatinanahia.
Hītori o te Whanaketanga cGMP: Ko te cGMP e whakaaetia ana e te ao, ahakoa i roto i te United States, i roto rānei i a Europe, i tēnei wā ko te tirotiro hanganga cGMP i ngā wāhi whakaputa e whai ana i ngā whakaritenga cGMP kotahi mō ngā rauemi mata i hangaia e te International Conference on Harmonization (ICH), e mōhiotia ana ko ICH Q7A. I ahu mai tēnei whakaritenga i te International Conference on Harmonization of Raw Materials (ICH for API) i Geneva, Switzerland i te marama o Hepetema 1997. I te marama o Poutū-te-rangi 1998, i arahina e te US FDA, i tuhia he "cGMP mō ngā rauemi mata", ICH Q7A. I te ngahuru o te tau 1999, i tae te Kotahitanga o Europi me te United States ki tētahi whakaaetanga whakaae tahi cGMP mō ngā rauemi mata. I muri i te mana o te whakaaetanga, i whakaae ngā taha e rua ki te whakaae ki ngā hua tiwhikete cGMP a tētahi ki tētahi i roto i te tukanga hokohoko o ngā rauemi mata. Mō ngā kamupene API, ko ngā ture cGMP te ihirangi motuhake o te ICH Q7A.
Te rerekētanga i waenga i te cGMP me te GMP
Ko te CGMP he paerewa GMP e whakatinanahia ana e ngā whenua pēnei i te Hononga o Amerika, o Ūropi, me Hapani, e mōhiotia ana ko te "paerewa GMP o te ao". Kāore ngā paerewa cGMP i rite ki ngā paerewa GMP e whakatinanahia ana i Haina.
Ko te whakatinanatanga o ngā ture GMP i Haina he huinga ture GMP e pā ana ki ngā whenua whakawhanake i whakatakotohia e te WHO, me te aro nui ki ngā whakaritenga mō ngā taputapu whakaputa pēnei i ngā taputapu whakaputa.
Ko te cGMP e whakatinanahia ana i ngā whenua pēnei i te Hononga o Amerika, Ūropi, me Hapani e arotahi ana ki te hanga pūmanawa, pēnei i te whakahaere i ngā mahi a ngā kaiwhakahaere me te whakahaere i ngā huihuinga ohorere i roto i te tukanga whakaputa.
(1) Whakataurite i ngā rarangi whakatakotoranga tiwhikete. Mō ngā huānga e toru o te tukanga whakaputa rongoā - ngā pūnaha taputapu, ngā pūnaha pūmanawa, me ngā kaimahi - he māmā ake te cGMP i te Hononga o Amerika, ā, he iti ake ngā wāhanga i te GMP i Haina. Heoi, he rerekētanga nui kei roto i ngā whakaritenga ā-roto mō ēnei huānga e toru. He nui ake ngā whakaritenga mō ngā taputapu i te GMP o Haina, engari he nui ake ngā whakaritenga mō ngā pūmanawa me ngā kaimahi i te cGMP o te Hononga o Amerika. Nā te mea ko te kounga whakaputa rongoā e whakawhirinaki ana ki te mahi a te kaiwhakahaere, nō reira he mea nui ake te tūranga o ngā kaimahi i roto i te whakahaere GMP i te Hononga o Amerika i te tūranga o ngā taputapu wheketere.
(2) Te whakataurite i ngā tohu mahi. I roto i te GMP o Haina, he ture taipitopito mō ngā tohu (taumata mātauranga) o ngā kaimahi, engari he iti noa ngā herenga mō ngā kawenga o ngā kaimahi; I roto i te pūnaha cGMP i te Hononga o Amerika, he poto, he mārama hoki ngā tohu (taumata whakangungu) o ngā kaimahi, engari he tino taipitopito ngā kawenga o ngā kaimahi. Mā tēnei pūnaha kawenga ka tino whakarite te kounga o te whakaputanga o ngā rongoā.
(3) Te whakataurite i te kohikohinga tauira me te tirotiro. Ko te GMP o Haina anake e whakarite ana i ngā tikanga tirotiro e tika ana, ko te cGMP i te United States ia e tohu ana i ngā mahi me ngā tikanga tirotiro katoa me te taipitopito, me te whakaiti i te whakapoauau me te poke o ngā rongoā i ngā wāhanga rerekē, inā koa i te wāhanga rauemi mata, me te whakarato i te whakapumautanga mō te whakapai ake i te kounga o te rongoā mai i te pūtake.
Ngā uauatanga ki te whakatinana i te cGMP
He maeneene te whakawhiti GMP o ngā umanga rongoā Hainamana. Heoi, kei te mau tonu ngā wero i roto i te whakatinanatanga o te cGMP, e whakaatahia ana i roto i te pono o ngā taipitopito me ngā tukanga.
Hei tauira, e hiahia ana tētahi kamupene rongoā i Ūropi ki te tomo ki te mākete o Amerika me tētahi rongoā rauemi mata e whai hua ana, ā, ka tukuna he hua whaimana ki te US FDA. I mua, i te wā o te tukanga hanga rauemi mata, i kitea he rerekētanga tika i roto i tētahi o ngā ine pāmahana e rua o te tāke tauhohenga. Ahakoa i tukatukahia e te kaiwhakahaere, ā, i tono tohutohu, kāore i tuhia e rātou ki ngā tuhinga puranga whakaputa. I muri i te whakaputanga o te hua, i tirohia noa e ngā kaitirotiro kounga ngā poke e mōhiotia ana i te wā o te tātari chromatography, ā, kāore he raruraru i kitea. Nō reira, i tukuna he pūrongo tirotiro whaimana. I te wā o te tirotiro, i kitea e ngā āpiha o te FDA kāore te tika o te inemahana i tutuki i ngā whakaritenga, engari kāore i kitea he tuhinga e rite ana i roto i ngā tuhinga puranga whakaputa. I te wā o te manatoko i te pūrongo tirotiro kounga, i kitea kāore te tātari chromatography i mahia i runga i te wā e hiahiatia ana. Kāore e taea e ēnei takahi katoa o te cGMP te mawhiti i te tirotiro a ngā kaititiro, ā, i te mutunga kāore tēnei rongoā i uru ki te mākete o Amerika.
Kua whakatau te FDA ko te korenga e tutuki i ngā ture cGMP ka pā kino ki te hauora o ngā kaihoko o Amerika. Mēnā he rerekētanga o te tika e ai ki ngā whakaritenga cGMP, me whakarite he rangahau anō, tae atu ki te tirotiro i ngā hua ka puta mai i te rerekētanga o te pāmahana mai i te tika, me te tuhi i te rerekētanga mai i te whakaahuatanga o te tukanga. Ko ngā tirotiro katoa o ngā rongoā he mea mō ngā poke e mōhiotia ana me ngā matū kino e mōhiotia ana, ā, mō ngā wāhanga kino, kāore e mōhiotia ana, kāore e pā ana ki a rātou, kāore e taea te kite whānuitia mā roto i ngā tikanga o nāianei.
I te aromatawai i te kounga o tētahi rongoā, he maha ā mātou whakamahi i ngā paearu tirotiro kounga hei whakatau mēnā he tika te rongoā, he mea rānei i runga i te whai huatanga me te āhua o te hua. Heoi, i roto i te cGMP, ko te ariā o te kounga he tikanga whanonga e rere ana puta noa i te tukanga whakaputa katoa. Tērā pea kāore e tutuki i tētahi rongoā tino tika ngā whakaritenga o te cGMP, nā te mea tera pea ka rerekē tana tukanga. Mēnā kāore he whakaritenga ture tino pakari mō te tukanga katoa, kāore e taea te kite i ngā tūponotanga kino e ngā pūrongo kounga. Koia te take kāore i te ngāwari te whakatinanatanga o te cGMP.
Wā tuku: Hurae-26-2023