MalondaMalonda padziko lonse

GMP muyezo mayiko: Makhalidwe ndi ntchito

GMP muyezo m'mayiko imodzi ya yaikulu padziko lapansi, amasonyeza zofunika kwa kupanga asatayike, zowonjezera zakudya ndi ngakhale zakudya.

Kodi muyezo?

Dzina zonse izi ya amafuna - ". Malamulo kupanga mankhwala" Good Kupanga katundu Khalani kwa mankhwala Zamgululi, omwe anamasuliridwa ngati GMP muyezo lonse ali ndi zolinga izi:

  1. Perekani mkulu mlingo wa mankhwala khalidwe.
  2. Kuonetsetsa kuti:
  • Mankhwala mitunduyi mankhwala ntchito ngati;
  • mu chiphunzitso cha lilibe zosafunika;
  • ndi olemba yoyenera;
  • suitably mmatumba lokonzekera
  • izo sasiya katundu wake pa tsiku lothera ndi.

Mbiri ya yatsoka

Yambani muyezo anali anayambitsa mu US mu 1963, pamene analowa kukhala ulamuliro loyamba kupanga otetezeka ndi apamwamba mankhwala. Muyezo mawonekedwe a Chikalata chimene boma Komabe, iwo analandira okha mu 1968. Patapita chaka chimodzi, la World Health Organization (WHO) tikulimbikitsidwa kuti mayiko onse ntchito padziko lonse GMP muyezo. Kenako, malamulo amenewa mobwerezabwereza wodzilemekeza ndiponso chilango sitinalandire anatengera chikuoneka pano.

Poyera ananyalanyaza muyezo pa siteji koyamba kukhazikitsa koma Soviet Union, umene Ministry of Health zachitika mchikhalidwe chake, nthawi zina choposa austerity GMP. Chidwi mfundo m'mayiko ena anayamba kutuluka yekha mu 1991, pamene ndondomeko anayamba ndi yoti ndi exporting mankhwala. Komabe, kukwaniritsa mogwirizana ngati malamulo osiyana sakanakhoza poyamba. Only kuyambira 90s panali ena kusintha kwenikweni.

Russian muyezo

Chimango zolimbana m'mayiko CIS anayamba atamwalira ndi kugwa kwa USSR. Cholinga chachikulu chinali - pamaziko a mfundo yapita mmene ndingathere kugwirizanitsa mfundo ziwiri, pang'onopang'ono kuyandikira malamulo kumatanthauza wa GMP (mayiko khalidwe muyezo).

Ndondomeko anali yaitali limodzi. Only mu 2001 anaonekera pafupi mfundo mayiko latsopano la Russia. Iwo ikuti kuti ndi 01.07.2000 zonse zinalengedwa ndi ankamangidwanso mabizinezi kwa kupanga mankhwala adzalandira chilolezo kupanga, yosungirako ndi kugulitsa katundu ndi nkhani yokhayo litsatidwe Russian lofanana GMP.

Iwo ankachita nawo chitukuko cha bungwe lotchedwa Association of Akatswiri kulamulira micropollutants (ASINKOM). malamulo zoweta anali ovomerezeka ndi boma Standard wa ku Russia 10.04.2004, kubweretsa anaonekera GOST R 52249-2004 "Malamulo a ulimi ndi kulamulira khalidwe la mankhwala." Iye linakhazikitsidwa 01.01.2005 ndipo ankaganiza kuti mfundo imeneyi ngati kuli kotheka kusonkhanitsa lonse. Komabe, kuchokera 01.01.2010 limodzi ndi Russian dziko GMP muyezo. Iye anatenga monga maziko malamulo European, ndipo zakale GOST anataya kufunika kwake.

Kodi mu Russia zili kutsatira ogwira ntchito muyezo

Ambiri mabizinesi amene analandira zikalata quality, malinga ndi malamulo lonse, pamene Moscow, St. Petersburg ndi zina zikuluzikulu malo mafakitale ndi sayansi ya dziko.

Iwo ankafuna kuti amalize kumasulira kwa GMP (muyezo wa maiko onse) mwa makampani onse. Komanso, iye anali kuthetsa mwamsanga 2014, koma panali mabvuto. Kunapezeka kuti aliyense ogwira zoweta makampani mankhwala akhoza kupeza yoyenera satifiketi khalidwe. Waukulu vuto - palibe ndodo mokwanira ongolankhula ndi, Chofunika kwambiri, manja pa maphunziro pa kukhazikitsa mfundo m'gawo Russian.

zofunika za muyezo GMP

Standard GMP (Good Kupanga katundu Khalani) imapereka ya zizindikiro yoti opanga mankhwala. Komanso, chifukwa mankhwala mwatsatanetsatane malamulo amafuna aliyense siteji ya ulimi - ndende mabakiteriya ali mita kiyubiki wina wa mpweya, pamaso olemba.

Mwachitsanzo, lamulo makampani popanga mapiritsi mankhwala. Zikatero, GMP (muyezo mayiko) kumafuna dongosolo "ultrapure masitolo" imene kuchuluka sterility ndondomeko umalandira zipata kumtunda kwa ogwira mode wapadera wa kusefera mpweya ndi m. N. mu Russia masitolo ngati opangidwa okha pakachitsulo makhiristo ndi Chip wapadera.

Kodi ndi zinthu ziti zofunika kusintha kwa muyezo?

Kuika makampani Russian ku International Standard GMP, ndipo muyenera zinthu kunja ndi mkati. Pa mlingo boma chofunika:

  • Kuti akonze malamulo, zolimbana ndi methodological chimango amene angagwiritsidwe ntchito kukonza kuwunika zoletsedwa ndi malamulo amenewa. Pali zofunika ochita chipikisheni mmalo oyenerera amene ali pa dzanja adzakhala zofunikila zipangizo methodological kuyang'anira amakampani kwa issuance wa zikalata, komanso malamulo kutibweretsera perpetrators chilungamo.
  • Kukhazikitsa chitetezo cha kulembetsa mankhwala mankhwala omwe akakumane amafuna masiku ano. Izi ndi zoona makamaka mu gulu la "ubwino", chifukwa akatswiri a masiku ano kulamulira ndi chilolezo si Choyenereza chokwanira. Komanso kudziŵidwa ukonde palibe motsindika khalidwe la mankhwala yotsirizidwa. Komabe malonda kwambiri zimene mtengo wa mankhwala, nthawi zina moyo wa mogwira awo.

Kuchita GMP muyezo, malamulo GMP pa akumakhudzanso ntchito za bizinesi pazikhalanso zinthu zotsatirazi:

  • zida zamakono ndi maofesi a zomangamanga alipo, zofunika zogwirizana a muyezo.
  • Magwero a zipangizo zomwe zingagwiritsidwe ntchito kukwaniritsa khalidwe Napempha kwa mankhwala.
  • antchito aluso kupanga akatswiri, komanso amaphunzitsidwa upscale, kuyan'anila khalidwe la chomaliza mankhwala.
  • Mulingo woyenera gulu la ntchito.
  • Baibulo la zolembedwa zonse luso ndi kuchibweretsa icho mu mzere ndi zofuna za muyezo.
  • Okwanira mlingo wa kubwerera, umene amapereka chifukwa cha chitukuko cha ulimi ndi kupanga mankhwala atsopano.

Kodi ndifunika muyezo kumwa mankhwala Chitaganya cha Russia?

Mu mafunso ngati zofunika GMP (muyezo mayiko) mu Russia anthu amaona zinthu ziwiri.

1. Pa dzanja lina, mogwirizana ndi malamulo ake kuyeza amalola kuukitsa bala la mankhwala apamwamba pa mlingo wapamwamba kwambiri. Chiwerengero cha Russia ndiye kutenga kwambiri kothandiza ndiponso wochezeka mankhwala amene angamuthandize zochepa odwala ndi zambiri achire.

2. Mosiyana, mabungwe ang'onoang'ono zoweta si ndalama, "kukoka" kutembenuka. Ngati kampani ukulephera kumasulira mu mayendedwe amakono, mtengo wa mankhwala zikuchulukirachulukira kwambiri, ndipo awo kukhazikitsa ndi zovuta.

Ziŵirizo ku Russia amakhala zosemphana ndi kulepheretsa kukhazikitsa muyezo. Komabe, chifukwa cha mavuto atsopano geopolitical ndi kufunika inatha m'malo mankhwala ndondomeko ayenera imathandizira posachedwapa.

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