GMP paerewa ao: Āhuatanga me tono

whakaaro GMP paerewa ao te ki kia kotahi o te nui i roto i te ao, tautuhi nga whakaritenga mo te hanga o pharmaceuticals, tāpiringa kai, me te ara kai.

He aha te mea te paerewa?

Ko te ingoa tonu o tenei huinga o ngā whakaritenga - ". Ko nga ture o te hanga hauora" Practice Manufacturing pai mo rongoā Products, e whakamāoritanga rite He te whāinga e whai ake nei GMP paerewa ao:

1. Whakarato i te taumata tiketike o te kounga hua.
2. Me whakarite e:

• Tātai Hua rongoā taua tono;
• i roto i te waihanga e kore i roto i poke;
• i te tapanga tika;
• tika tākai faaineineraa;
• e kore te reira e ngaro ona āhuatanga i runga i te rā paunga.

Ko te hītori o te takanga

Tīmata tīmataria te paerewa i roto i te US i 1963, ka haere mai ki te te ture tuatahi o haumaru, me te tiketike-kounga ahumahi o ngā rongoā. Ko te puka paerewa o te tuhinga e pā ana, Heoi, whakaaetia ratou anake i roto i te 1968. He tau i muri mai, te Health Organization World (WHO) tūtohutia e whenua katoa te tono ki te paerewa GMP ao. I muri, toutou tāpiri enei ture, ka papaki, kihai i matou ano whāngai tona ahua reira.

Nuitia tukunoa'i te paerewa i te wāhanga tuatahi o tona whakatinanatanga ko te Soviet Union, o nei kua whakawhanakehia te Manatū o Hauora ona ake tikanga, i ētahi wā rawa austerity GMP. Interest i roto i ngā paerewa o te ao ka anga ki te puta anake i roto i te 1991, ka timata te tukanga i te kawemai me te kaweake taero. Heoi, ki te whakatutuki i te au maite i taua o ture rerekē taea kore i te tuatahi. Anake mai i te 90 i reira ko etahi tūturu ahunga whakamua.

paerewa Russian

Te anga ture i roto i te whenua Kihi ka anga ki te kia whakawhanakehia i muri i te parariraa o te USSR. Ko te whakaaro matua ko - i runga i te pūtake o ngā paerewa o mua nui taea ki te houhanga rongo i te paerewa e rua, āta tata nga ture tautuhia o GMP (paerewa kounga ao).

Tukanga ko te roa, kotahi. Anake i roto i te 2001 ka puta tata ki te paerewa o te ao i roto i te Russian Federation. pü te reira e ki 01.07.2000 ka riro hanga me toe langa hinonga katoa mo te hanga o te raau taero i te raihana mo te hanga, te rokiroki me te hoko o ngā hua, ko te kaupapa anake ki hanganga ture ki te ōrite Russian o GMP.

I whai wāhi te reira i roto i te whanaketanga o te whakahaere i huaina te Association o Engineers ki te whakahaere micropollutants (ASINKOM). ture Domestic i whakaaetia e te State Paerewa o te Russian Federation 10.04.2004, mau mai he puta GOST R 52249-2004 "Ture o te hanga me te mana kounga o raau taero." I meingatia e ia 01.01.2005, a ka whakaaro te reira e tenei paerewa nui taea mau mai i tahi te ao. Heoi, piri i 01.01.2010 te Russian paerewa GMP motu. ka mau ia rite te pūtake te ture Pākehā, me te GOST mua ngaro tona hāngaitanga.

Hea i roto i Russia e kei tono paerewa hinonga

Ko te nuinga o te pakihi e kua riro tiwhikete o te kounga, i runga ki te ture o te ao, i roto i Moscow, St Petersburg me ētahi atu pokapū nui ahumahi, me te pūtaiao o te whenua.

Kei te whakaritea te reira ki te whakaoti i te translation mo GMP (te paerewa ao) o hinonga katoa. Ano, i ia ki te mutu rite wawe rite 2014, engari i reira ko tetahi rota o fifi. tahuri te reira i roto i taua taea ki te tiki i te tiwhikete te kounga e tika ana e kore nga hinonga kāinga o te ahumahi ho'oraa he. Ko te raruraru matua - e kore ngā kaimahi ki ranea ariā, me te, tino nui, ringa-i runga i whakangungu i runga i te whakatinanatanga o ngā paerewa i roto i te rohe Russian.

āhuatanga Basic o paerewa GMP

Paerewa GMP (Pai Manufacturing Practice) whakarato te huinga o tohu ki te kia tutaki e kaiwhakanao o ngā hua. Ano, hoki taka rongoā whakaritea taipitopito whakaritenga mo ia wāhanga o te production - te kukū o te huakita i roto i te kotahi mita pūtoru o rangi, i mua i tapanga.

Ka rite ki te tauira, te whakaritenga hoki ngā kamupene whakaputa papa rongoā. I roto i ngā take pēnei i, GMP (paerewa ao) titau whakahaere "toa ultrapure" i roto i i nui haere tae tukanga sterility nga kuwaha whakarunga mō kaimahi aratau motuhake o te filtration rangi me te m. N. I roto i Russia taua toa hua anake tioata silicon me maramara motuhake.

He aha ngā āhuatanga e tika ana mo te whakawhiti ki te paerewa?

Hei hoatu i te kamupene Russian ki te paerewa GMP ao, a ka hiahia tikanga waho, me te ā. I te taumata kāwanatanga hiahiatia te:

• Hei waihanga i tētahi anga ture, ture, me te huarahi e taea te whakamahi ki te whakarite i te aroturuki o te tautukunga ki enei ture. Ka hiahiatia He kaitirotiro tohu e whai i runga i te ringa e ngā rauemi huarahi mō te tirohanga o hinonga ki te issuance o tiwhikete, me te ture i runga i mau mai i hara ki te tika.
• A haamau i te pūnaha o te rēhita o ngā hua rongoa nei e whakatau whakaritenga hou. he pono rawa i roto i te kāwai o "kounga" tenei, no te mea te whakahaere ngaio o tenei ra, me te kore he whakamanatanga rawaka tohu. Ano, i roto i te te more kahore aronga i runga i te kounga o te hua oti. Tonu hāngai atu hokohoko i runga i te utu o taero, i ētahi wā ki te whara o ratou tōtika.

Hei te mahi GMP-paerewa, kia ngā ture GMP i te taumata hinonga nga tūemi e whai ake nei:

• taputapu Modern me ngā whakaurunga o te hanganga ngā, nga whakaritenga e hāngai ana o te paerewa.
• Rauemi o ngā rauemi mata e taea te whakamahi ki te whakatutuki i te kounga hiahiatia o ngā rongoā.
• kaimahi mohio production, tohunga, me te tikanga upscale, te aroturuki i te kounga o te hua whakamutunga.
• Arotau whakahaere o te mahi.
• Whakahōunga o ngā tuhinga hangarau katoa, me te mau mai i te reira ki te raina ki te whakaritenga o te paerewa.
• Rawaka tere o hoki, e ka whakarato hoki i te whanaketanga o te hanga me te hanga o te raau taero hou.

E hiahia ana ahau i te kara mo te kohi o te raau taero i roto i te Russian Federation?

I roto i whakautu te pātai o mehemea te tika GMP (te paerewa ao) i roto i Russia te tikanga whakaaro e rua ngā āhuatanga.

1. I runga i te ringa kotahi, tautukunga me ona ture pākaha taea ki te whakaara i te pae o te raau taero kounga i te taumata tiketike rawa. Ko te taupori o Russia reira ka whiwhi i te rongoa tino tōtika, me te hoa e tukua iti mate me te ake pea ki te ora.

2. I te tahi atu te ringa, e kore e tika moni hinonga kāinga, "wahia" te faafariuraa. Ki te kore te kamupene ki te iriti i ki ara hou, kei te piki haere tino te utu o ngā rongoā, me he uaua ratou whakatinanatanga.

E tonu rua o enei āhuatanga i roto i Russia i pakanga, me te arai i te whakatinanatanga o te paerewa. Heoi, i roto i te tirohanga o te mau ka hāpaitia e hou, me te hiahia hoki kia whakatere kawemai whakauru o tukanga rongoā i roto i te heke mai e tata ana.