GMP dzakawanda mureza: Unhu mafomu

GMP dzakawanda mureza anoonekwa kuti mumwe guru munyika, inorondedzera zvinodiwa kuti pagadzirwe Pharmaceuticals, Mishonga zvokuwedzera uye kunyange zvokudya.

Chii mureza?

Zita azere yakatarwa iyi zvinodiwa - ". The nemitemo yezvokurapa kugadzirwa" Good Manufacturing Practice pakurapa. Products, iro anoshandura sezvo GMP dzakawanda mureza ane anotevera zvinangwa:

1. Huchaunza yakakwirira azvipire chigadzirwa yepamusoro.
2. Onai kuti:

• Product zvokuimba mushonga chikumbiro chakadaro;
• ari Pfungwa harina marara;
• kuva akakodzera Kunyora;
• zvakakodzera mumapepa gadziriro;
• haina kurasikirwa ehupfumi ayo pamusoro musi wazvinenge.

Nhoroondo chiitiko

Tanga mureza yakatangwa muna US muna 1963, apo raivapo Kutonga vakachengeteka uye yepamusoro kugadzira mishonga okutanga. Zvisinei, The Standard chakafanana yorugwaro, vakagamuchira chete muna 1968. Kwapera gore, World Health Organization (WHO) rakarumbidza kuti nyika dzose kushandisa dzakawanda GMP mureza. Zvadaro, mitemo iyi kakawanda vaisanganisa uye akaruramisa, hatina asi vava aripo chitarisiko.

Pachena kuteerera mureza panguva kutanga kwekupwanyiwa kwayo Implementation asi neSoviet Union, iyo Bazi Health kwakasimbiswa pachake dzemunharaunda ayo, dzimwe nguva kwazvo austerity GMP. Kufarira dzakawanda nemitemo vakatanga kubuda chete muna 1991, apo muitiro akatanga importing uye kwekurasira zvinodhaka. Zvisinei, kuti vabudirire kupindirana mitemo yakasiyana kwakadaro vasingagoni pakutanga. Chete sezvo 90s paiva nevamwe mberi chaiko.

Russian mureza

The pamutemo framework ari Kishi nyika yakatanga kugadzirwa mushure pokuwa USSR. Chinangwa chikuru chaiva - pahwaro yapfuura mitemo napo kuwiriranisa mitemo miviri, zvishoma nezvishoma pedyo mitemo yakajeka pamusoro GMP (dzakawanda unhu mureza).

Process yaiva yakareba mumwe. Chete muna 2001 akazviratidza pedyo dzomunyika mitemo iri Russian Federation. It iroro kuti pamwe 01.07.2000 zvose zvakasikwa uye reconstructed emakambani kuti pagadzirwe zvinodhaka achawana rezinesi kuti gadzira, okuchengetera uye kutengeswa mishonga iri chete pasi zvaidiwa Russian nerokuti GMP.

Zvakange mubasa kukura kwesangano anonzi Association of Engineers kudzora micropollutants (ASINKOM). nemirau Domestic vakanga anotenderwa neHurumende Standard of Russian Federation 10.04.2004, Kuunza akazviratidza GOST R 52249-2004 "Rules okuwana uye yepamusoro kudzora zvinodhaka." Akanga wakadzikwa 01.01.2005 uye zvaifungwa kuti mureza uyu napo kuunganidzwa dzakawanda. Zvisinei, kubva 01.01.2010 ndokubatana Russian National GMP mureza. Akatora mitemo European sezvikonzero, uye yaimbova GOST vakarasika kushanda kwayo.

Ndokupi Russia dziri kushandisa zvebhizimisi mureza

Ruzhinji mabhizimisi kuti vakagamuchira zvitupa quality, maererano nemitemo dzakawanda, apo muMoscow, St. Petersburg nezvimwe makuru maindasitiri uye kwesayenzi nzvimbo munyika.

Zvinonzi aronga kupedza shanduro nokuda GMP (International Standard) akaitwa zvose. Uyezve, aifanira agumise kare 2014, asi pakanga yakawanda nematambudziko. Zvakazozivikanwa kuti kwete ose epamba zvebhizimisi kuti mishonga indasitiri kuwana akakodzera yepamusoro gwaro. Dambudziko huru - hapana tsvimbo zvakakwana yokungotaura uye, Chikurukuru, maoko-kudzidzisa pamusoro Implementation zvinodiwa mundima weRussia.

Basic zvinhu GMP vomureza

Standard GMP (Good Manufacturing Practice) inopa mamwe zviratidzi kuti vakasangana nevanhu vanogadzira mishonga. Uyezve, nokuti vemishonga akadzama yaidzorwa zvinodiwa kuti kunenge okuwana - wevasungwa utachiona zviri imwe cubic mutinhimira mhepo, pamberi Kunyora.

Somuenzaniso, zvinodiwa kuti makambani kubereka mahwendefa mushonga. Muzviitiko zvakadaro, GMP (International Standard) zvinoda sangano "ultrapure zvitoro" umo yakawedzera kusabereka kwacho anosvika nechokumusoro kwerwizi pakuyera kuti vashandi rinokosha kwadzinoita ane mhepo filtration uye m. N. In Russia kuzvitoro dzakadaro yakabereka chete nesilicon crystals uye chinokosha chip.

Ndezvipi zvinhu zvinodiwa yezwi mureza?

Kuisa makambani Russian dzomunyika GMP mureza, uye vanoda kwokunze uye dzimwe ezvinhu. At hurumende pamwero runodiwa:

• Kuti pave nomutemo, pamutemo uye methodological framework anogona kushandiswa aronge richiona pokuita nemitemo iyi. Pane zvinodiwa dzinokwanisa vaongorori vane paruoko zvichabviswa detailed methodological zvinhu rokuongorora akaitwa kuti issuance kuti zvitupa, uyewo mitemo pandaivabudisa vanopara kuti kururamisira.
• Simbisai kwegadziriro kunyoresa somushonga zvigadzirwa izvo kuti zvinodiwa ano. Izvi ndezvechokwadi kunyanya vari muchikwata che "yepamusoro", nekuti nyanzvi anhasi kudzora uye mvumo haisi kodzero yakakwana. Uyezve, mune mambure realizable hapana Kumikidzo kunaka Finished chigadzirwa. Achiri Bhizimisi chinotaura zvakawanda pamusoro mutengo zvinodhaka, dzimwe nguva kune pakukuvadza kubudirira kwavo.

Kuti aite GMP-mureza, GMP mirayiro panguva zvebhizimisi pamwero kunofanira kusanganisira zvinhu zvinotevera:

• Modern midziyo uye zvivako aripo kwezvivako, kuMudzidzisi zvinodiwa mureza.
• Manyuko mbishi zvinhu zvinogona kushandiswa kuzadzisa zvinodiwa unhu mishonga.
• Unyanzvi Hwokuridza kugadzirwa vashandi, vanachiremba, uyewo upscale wevanamakanika, vachiongorora kunaka rokupedzisira chigadzirwa.
• Zvakanyanya Kunaka Panguva Yepamuviri sangano basa.
• Revision vose michina mapepa uye vachiuya nawo aenderane ne zvinodiwa mureza.
• Yakakwana zvazvingava kudzokerazve, izvo achapa kukura kugadzirwa uye kugadzirwa mishonga mitsva.

Ndinofanira mureza kudyiwa kwezvinodhaka muna Russian Federation?

Pakupindura mubvunzo wokuti kazhinji anodiwa GMP (International Standard) muna Russia anonzi zviviri.

1. Kudivi rimwe, zvaidiwa inoomesera mitemo yayo rinobvumira kusimudza muzariro yepamusoro madhiragi pane refu azvipire. Vagari Russia anofanira kuwana zvikuru vakarongeka uye ushamwari mishonga kuti kubvumira zvishoma vanorwara uye vangangowedzera apore.

2. Ukuwo, mudzimba emakambani havasi chete nemari, "kudhonza" kutendeutsa. Kana boka akakundikana kushandura kupinda pamakwara ano, mari mishonga iri kuwedzera zvikuru, uye Implementation yavo kunzwisisa.

Zvose izvi Russia vanongogara mukurwisana uye kudzivisa Implementation yemabhii. Zvisinei, tichitarisa itsva geopolitical chaizvoizvo uye kudiwa imupota kuzvitsinhanisa mishonga kwacho kunofanira mhanyisa munguva yemberi iri pedyo.