Ntchito Yabwino Yopangidwira (GMP)

M'mafakitala ena, opanga amafunikira kwambiri miyezo yopanga. Izi ndizomwe zili mu (zamankhwala amtundu wa anthu komanso Chowona), msika wazodzola ndi msika wazakudya. Njira Yabwino Yopangira Zinthu (GMP) ndi nthawi yodziwika bwino m'mafakitale awa. GMP ndi njira yotsimikizirira zaubwino yomwe imawonetsetsa kuti njira yopangidwira imalembetsedwa moyenera motero khalidwe limatsimikizika. Chifukwa cha gawo lalikulu pamafakitale opanga mankhwala ndi zodzola, ndi GMP yokha m'magulu awa yomwe ikukambidwa pansipa.

History

Chiyambireni chitukuko, anthu akhala ndi nkhawa zakuthupi ndi chitetezo cha chakudya ndi mankhwala. Mu 1202 lamulo loyambirira lachingerezi lidapangidwa. Pambuyo pake, mu 1902, Organic Control Act inatsatira. Izi zidayambitsidwa ku United States kuti zizitha kuyang'anira zinthu zachilengedwe. Izi zidayesedwa mwalamulo pa kuyera. Lamulo loyambirira la Chakudya ndi Mankhwala, lomwe lidakhazikitsidwa mu 1906 ndipo lidapangitsa kuti kukhale kosaloledwa kugulitsa zakudya zonyansa (ndikuti zilembedwe zoona. Pambuyo pake, malamulo ena angapo adayamba kugwira ntchito. Mu 1938, lamulo la Chakudya, Mankhwala Osokoneza Bongo ndi Zodzikongoletsera linayambitsidwa. Lamuloli limafuna kuti makampani azipereka umboni kuti zopangidwa zawo zinali zotetezeka komanso zoyera asanafike pamsika. A FDA adachita kafukufuku wamapiritsi oipitsidwa ndikuwonetsa kuti zoyipa zazikulu pakupanga zidapezeka mufakitoleyo ndipo sizinathenso kudziwa kuti ndi mapiritsi ena angati omwe adadetsedwa. Izi zidakakamiza a FDA kuchitapo kanthu ndikuletsa kubwerezabwereza pobweretsa ma invoicing ndikuwongolera zabwino kutengera miyezo yowerengera mankhwala onse. Izi zidapangitsa zomwe pambuyo pake zimatchedwa GMP. Mawu oti "Ntchito yabwino yopanga" adawonekera mchaka cha 1962 ngati kusintha kwa American Food, Drug and Cosmetic Act.

Ntchito Yabwino Yopangidwira (GMP)

Malangizo apano a European GMP adapangidwa ku Europe ndi United States.

Pambuyo pake maiko aku Europe nawonso adayamba kugwira ntchito limodzi ndikupanga malangizo ofanana a GMP omwe adalandiridwa ndi European Union.

Kuphatikiza apo, pali malamulo ena ambiri apadziko lonse lapansi momwe ma GMP anaphatikizidwira.

Kodi GMP ndi chiyani?

GMP amatanthauza "njira yabwino yopangira". Malamulo a GMP amaphatikizidwa m'malamulo amtundu uliwonse, koma kwenikweni malamulowa ali ndi cholinga chofanana. GMP imagwiritsidwa ntchito makamaka m'makampani opanga mankhwala ndipo cholinga chake ndi kutsimikizira kuti ntchitoyi ndiyabwino. Ubwino wa chinthu sichingadziwike kotheratu poyesa kapangidwe kake. Sikuti zonyansa zonse zimatha kupezeka ndipo sizinthu zonse zomwe zimatha kusanthula. Ubwino ungatsimikizidwe kokha ngati ntchito yonse yopanga ikuchitika moyenera komanso moyenera. Momwemonso njira yopangira imatsimikizira kuti mankhwala ndi abwino. Njira yopangira iyi, yotchedwa Njira Yabwino Yopangira, ndiyofunikira pakupanga mankhwala.

GMP ndiyofunikanso kwambiri pamgwirizano wapadziko lonse. Mayiko ambiri amangovomera kutumiza ndi kugulitsa mankhwala omwe amapangidwa molingana ndi GMP yovomerezeka padziko lonse lapansi. Maboma omwe akufuna kulimbikitsa kutumiza kunja kwa mankhwala atha kuchita izi popanga zovomerezeka za GMP popanga mankhwala onse komanso pophunzitsa owunika m'malangizo a GMP.

GMP imafotokoza momwe ndi momwe amapangira mankhwala. Pakupanga zinthu zonse, zosakaniza, zogulitsa zapakatikati ndi zotsirizira zimayendera ndipo njirayi imalembetsedwa molondola pa protocol yokonzekera. Ngati pambuyo pake china chake sichili bwino ndi gulu lina la zinthu, ndizotheka kudziwa momwe zimapangidwira, yemwe adaziyesa ndi kuti ndipo zidagwiritsidwa ntchito bwanji. Ndikothekanso kutsatira komwe zidalakwika.

Ngakhale kuwongolera koyenera ndikofunikira kutsimikizira mtundu wa mankhwala opangira mankhwala, ziyenera kuzindikirika kuti cholinga chotsiriza cha kuwongolera bwino ndikwaniritsa ungwiro pantchito yopanga. Kuwongolera bwino kunapangidwa kuti kutsimikizireni ogula kuti chinthucho chikugwirizana ndi miyezo yabwino, kulembera zolondola ndi zonse zololedwa. Komabe, kuwongolera kwapamwamba kokha sikokwanira kukwaniritsa zolinga zonse. Payenera kukhala kudzipereka kuti tikwaniritse mtundu uliwonse komanso kudalirika m'zinthu zilizonse, mtanda uliwonse. Kudzipereka kumeneku kumatha kufotokozedwa bwino monga GMP.

Malamulo ndi malangizo

Maupangiri a GMP amayikidwa mu malamulo ndi malamulo osiyanasiyana pamakampani osiyanasiyana. Pali malamulo ndi malamulo apadziko lonse lapansi, koma palinso malamulo ku Europe ndi mayiko.

mayiko

Kwa makampani omwe amatumiza kunja ku United States, malamulo a GMP a United States Food and Drug Administration (FDA) akugwira ntchito. Amatsatira malamulo omwe ali pansi pa mutu 21 wa Code of Federal Regulations. Malangizowa amadziwika kumeneko potengera mawu akuti "Current Good Production Production (cGMP)".

Europe

Malangizo a GMP omwe amagwiritsidwa ntchito mu EU akhazikitsidwa mu malamulo aku Europe. Malamulowa amagwiritsidwa ntchito pazogulitsa zonse zomwe zikugulitsidwa ku European Union mosasamala kanthu kuti wopanga amakhala kunja kwa EU.

Kwa mankhwala omwe amagwiritsidwa ntchito ndi anthu, malamulo ofunikira kwambiri ndi malamulo 1252/2014 ndi Directive 2003/94 / EC. Kwa mankhwala omwe amapangidwira ntchito zowona zanyama ndi Directive 91/412 / EC yofunikira. Pali malamulo ndi malangizo ena okhudzana ndi misika yamankhwala. Zofunikira za GMP ndizofanana kwa anthu monga momwe amachitira ndi makampani opanga mankhwala. EudraLex ndi mndandanda wa malamulo omwe amagwiritsa ntchito mankhwala mkati mwa EU. Voliyumu 4 ya EudraLex ili ndi malamulo a GMP. Bukuli ndi buku logwiritsa ntchito malangizo ndi mfundo za GMP. Malamulowa amagwiranso ntchito kwa anthu komanso nyama. 

National

Unduna wa Zaumoyo, Moyo Wathanzi ndi Masewera amasankha pamlingo wapadziko lonse womwe chithandizo chamankhwala chitha kutumizidwa kunja komwe kungachitike ndikuwonetsa chithandizo chamankhwala. Lamulo la Medicines limafotokoza momwe kupangira mankhwalawa kungapangidwire, kugulitsa ndikugawa kwa wodwala. Mwachitsanzo, lamulo la Opium limaletsa kukhala ndi mankhwalawa atchulidwa mndandanda ndi malamulo a Opium Act. Palinso lamulo pazoyambira. Malinga ndi malamulowa, ogulitsa mankhwala amatha kugula ndi / kapena kugulitsa mankhwala omwe angagwiritsidwe ntchito kupanga mankhwala osokoneza bongo kapena akaphulika (oyambira) munthawi zina. Palinso malamulo ndi malangizo monga mtundu wa FMD (muyeso wotsutsana ndi kuchuluka kwa manambala) ndi malangizo a KNMP osamalira zamankhwala ndi Dokotala Wama Dutch.

European Medicines Agency (EMA) imayang'anira kuwunika kwa sayansi, kuyang'anira ndi kuwongolera chitetezo pamankhwala ku EU. Malamulo a Zodzikongoletsera za cosmetic amakhazikitsa zofunika kuti munthu azipanga zodzola.

Zofunikira za GMP

GMP ndi gawo lakutsimikizira zabwino. Mwambiri, chitsimikizo ichi, kupatula GMP, chimaphatikizaponso magawo monga kapangidwe kazinthu zopangira zinthu. Chitsimikizo chazinthu zonse ndi zomwe zikuyenera kuwonetsetsa kuti malonda kapena ntchito ikugwirizana ndi zofunikira. Chitsimikizo chabwinobwino ndichimodzi mwazinthu zoyambira kasamalidwe kabwino. Kufunika kwa kasamalidwe kabwino ndikofunikira. Ngati mungaganizire kwakanthawi zomwe zingachitike ngati zolakwitsa zidapangidwa pakupanga mankhwala ndikupezeka mochedwa. Kupatula kuvutika kwaumunthu, zikanakhala zowopsa mbiri ya kampani yopanga mankhwala. Njira zabwino zopangira zimayang'ana pachiwopsezo chazomwe zimachitika pakupanga mankhwala, monga kuipitsa pamtanda (kuipitsa mankhwala amodzi ndi zigawo zina za mankhwala ena) ndi zosakanikirana (zolakwika) zomwe zimachitika chifukwa cholemba zabodza.

Zofunikira zomwe GMP imayika pakupanga zinthu zimagwirizana padziko lonse lapansi. Blog iyi ikuwonetsa zofunikira kuchokera pamalamulo okhudzana ndi malonda ogulitsa mankhwala. Mwambiri, mfundo zomwezo zimagwiranso ntchito pamakampani aliwonse. Mfundo zachikhalidwe izi zimalekananso padziko lonse lapansi.

Malamulo aku Europe amafunikira kuti mankhwala azachipatala azipangidwa motsatira mfundo ndi malangizo a machitidwe abwino. Zomwe zatchulidwa ndi malangizowa ndi kuwongolera bwino, ogwira ntchito, malo ndi zida, zolemba, kupanga, kuwongolera zinthu, kuyanjanitsa, madandaulo ndikukumbukira zinthu komanso kudziyang'anira. Malamulowo amakakamiza wopanga kuti akhazikitse ndikukhazikitsa njira yolimbitsira mankhwala. Malamulowa amagwiranso ntchito pazinthu zamafuta zomwe zimapangidwira kunja.

Malangizo a GMP awa ayenera kuganiziridwa:

  • Ogwira ntchito bwino, ophunzitsidwa bwino,
  • Ukhondo umasamalidwa bwino. Ngati wina, mwachitsanzo chifukwa cha matenda opatsirana kapena bala lotseguka, pali chidziwitso chotsatira ndikutsatira protocol.
  • Kuyesedwa pafupipafupi kwa ogwira ntchito
  • Kwa ogwira ntchito omwe amayendera zojambula, palinso kuwunika kowonjezera,
  • Zida zoyenerera,
  • Zipangizo zabwino, muli ndi zolembera,
  • Malangizo ovomerezeka,
  • Malo osungira komanso zoyenera
  • Ogwira ntchito zokwanira, ma labotale ndi zida zamagetsi zolamulira zamkati,
  • Malangizo a ntchito (Njira Zogwira Ntchito); malangizo a ntchito alembedwa mchilankhulo chomveka bwino ndikuwunika zomwe zikuchitika m'deralo,
  • Maphunziro; ogwira ntchito ophunzitsidwa bwino amaphunzitsidwa kuti azitsatira malangizo a ntchito,
  • Zolemba; Chilichonse chizikhala momveka papepala komanso kuyenera kwa ogwira ntchito
  • Zambiri pamalembedwe ndi njira yolemba zopangira, zinthu zapakatikati ndi zomalizidwa,
  • Pali mitundu yotsimikizika, yotsimikizika, yodalirika yopangira malo,
  • Kuyendera ndi kutsimikizika kwachitika,
  • Mukamapanga (zolemba pamanja kapena zojambula zokha) zimalembedwa ngati masitepe onse achitika molondola,
  • Zochenjera ndi zomwe zalembedwa ndikujambulidwa mwatsatanetsatane,
  • Mbiri yonse ya batani iliyonse (kuchokera pazopangira makasitomala mpaka makasitomala) imasungidwa kuti izitha kutsatiridwa,
  • Zogulitsazo zimasungidwa ndikuyendetsedwa molondola,
  • Pali njira yochotsera mabatani ogulitsa ngati pakufunika kutero,
  • Madandaulo okhudza mavuto apamwamba amathetsedwa ndikuwunika moyenera. Ngati ndi kotheka, pamachitika zinthu zopewa kuti zisadzabwerenso. 

maudindo

GMP imapereka maudindo angapo kwa otsogola, monga mutu wazopanga ndi / kapena kuwongolera kwabwino ndi munthu wovomerezeka. Wololezedwa ali ndi udindo wowonetsetsa kuti njira zonse ndi mankhwala akupangidwa ndikugwiridwa molingana ndi malangizo. Amasaina (kwenikweni) pamtundu uliwonse wa mankhwala ochokera ku fakitaleyo. Palinso manejala wamkulu, yemwe ali ndi udindo wowonetsetsa kuti zinthuzo zikukwaniritsa zofunikira zalamulo ladziko pazogulitsa zamankhwala, osayika odwala pachiwopsezo chifukwa chosowa chitetezo, luso kapena mphamvu. Ziyenera kukhala zowonekeratu, komanso ndichofunikira kuti mankhwalawo akhale oyenera cholinga chake. 

Kuyang'anira ndi GMP satifiketi

Pa onse ku Europe ndi kudziko lonse, pali owongolera omwe amayang'anira ntchito yoyang'anira. Awa ndi European Medicines Agency (EMA) ndi Health Care and Youth Inspectorate (IGJ). Ku Netherlands, IGJ imapereka satifiketi ya GMP kwa wopanga mankhwala ngati atsatira malangizo a GMP. Kuti izi zitheke, IGJ imasanthula nthawi ndi nthawi opanga ku Netherlands kuti afufuze ngati amatsatira malamulo a GMP. Ngati malamulo a GMP sakukwaniritsidwa, wopanga sangangobedwa pa chitupa cha GMP, komanso chilolezo chopanga. IGJ imayang'ananso opanga omwe ali kunja kwa European Union. Izi zimachitika mothandizidwa ndi EMA ndi Medicines Evaluation Board (CBG).

Komanso atapemphedwa ndi Medicines Evaluation Board, IGJ imalangiza opanga omwe ali mu chikalata chololeza kutsatsa (chilolezo patsamba). Ngati wopanga sakugwira ntchito molingana ndi zofunikira za GMP, Board itha kusankha kuti wopangayo achotsedwe pachidziwitso chololeza kutsatsa. A Board amachita izi polumikizana ndi IGJ ndi oyang'anira ena aku Europe oyang'anira ndi mabungwe aku Europe monga Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) ndi EMA. Ngati izi zitha kubweretsa kusowa kwa mankhwala ku Netherlands, wololeza wotsatsa ayenera kufotokozera izi ku Medicines Deficience and Defects Disclosure Office (Meldpunt geneesmiddelen tekort en -defecten).

Zodzola komanso GMP

Pazodzola, pali malamulo osiyana kuti atsimikizidwe. Pamlingo waku Europe pali Cosmetics Regulation 1223/2009 / EC. Izi zikuwonetsanso kuti zodzoladzola ziyenera kutsatira GMP. Upangiri womwe wagwiritsidwa ntchito pa izi ndi muyezo wa ISO 22916: 2007. Mulingo uwu uli ndi mfundo zoyambirira za GMP zomwe zimayang'ana makampani omwe amapanga zodzoladzola zomalizidwa. Uwu ndiye mulingo wapadziko lonse lapansi ndipo wavomerezedwanso ndi European Committee for Standardization (CEN). Ili ndi bungwe loyimira ku Europe lomwe limapanga miyezo yomwe ikufunika kwambiri. Kugwiritsa ntchito miyezo imeneyi sikofunikira, koma kukuwonetsa kudziko lakunja kuti malonda kapena ntchitozo zimakwaniritsa miyezo yabwino. Bungwe loyimilira limakhazikitsanso 'miyezo yolingana' popempha European Union.

Malamulowa a GMP omwe atchulidwa muyezo amakhala ndi cholinga chofanana ndi cha makampani opanga mankhwala: kutsimikizira mtundu ndi chitetezo. Muyeso uwu umangowona za makampani azodzola. Mulinso ndi:

  • kupanga,
  • kusunga,
  • ma CD,
  • kuyesa ndi kayendedwe
  • kafukufuku ndi chitukuko
  • kugawa zodzola zomalizidwa
  • chitetezo cha ogwira ntchito opanga
  • kuteteza chilengedwe.

Muyezo umangowonetsetsa kuti kugwiritsa ntchito zinthu zofunikira ndizofunikira pakupanga katundu. Kugwiritsa ntchito muyezo kumalola wopanga kuti azisamalira zofunikira komanso chitetezo pazogulitsa ndikuwunika ngozi ndi zoopsa za zodzola. Malamulo a GMP amafanana ndi malamulo omwe adatchulidwa kale mwatsatanetsatane mu "Zofunikira za GMP".

Kodi mukufuna upangiri kapena thandizo pa malamulo azachipatala kapena malamulo azodzola? Kapena kodi muli ndi mafunso pa blog ino? Chonde funsani maloya ku Law & More. Tikuyankha mafunso anu ndikupereka chithandizo chalamulo pakafunika.

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