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
Kuyambira chiyambi cha chitukuko, anthu akhala akuda nkhawa ndi ubwino ndi chitetezo cha chakudya ndi mankhwala. Mu 1202 chakudya choyamba cha Chingerezi chilamulo analengedwa. Zinali pambuyo pake, mu 1902, pamene Organic Control Act inatsatira. Izi zidayambitsidwa ku United States kuti aziwongolera zinthu zachilengedwe. Mankhwalawa adayesedwa mwalamulo pa chiyero. Lamulo loyambirira la Chakudya ndi Mankhwala, lomwe linakhazikitsidwa mu 1906 ndipo linapangitsa kuti zikhale zoletsedwa kugulitsa zakudya zowonongeka (zabodza) ndipo zimafuna kuti zilembedwe zoona. Pambuyo pake, malamulo ena angapo anayamba kugwira ntchito. Mu 1938, Food, Drug and Cosmetic Act idakhazikitsidwa.
Lamuloli lidafuna kuti makampani apereke umboni woti zinthu zawo zinali zotetezeka komanso zoyera zisanayikidwe pamsika. A FDA adafufuza pamapiritsi omwe ali ndi kachilomboka ndipo adavumbulutsa kuti pafakitale pali zolakwika zazikulu zomwe zidapangidwa ndipo sizinali zothekanso kudziwa kuti mapiritsi ena angati anali oipitsidwa. Chochitikachi chinakakamiza a FDA kuti achitepo kanthu ndikuletsa kubwerezanso poyambitsa ma invoice ndi kuwongolera khalidwe kutengera miyezo yowunikira pazamankhwala onse. Izi zidapangitsa zomwe pambuyo pake zidatchedwa GMP. Mawu akuti "Kupanga Zabwino" adawonekera mu 1962s ngati kusintha kwa American Food, Drug and Cosmetic Act.
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 akuphatikizidwa mumitundu yonse ya malamulo, koma kwenikweni malamulowa ali ndi cholinga chomwecho. GMP imagwiritsidwa ntchito makamaka m'makampani opanga mankhwala ndipo cholinga chake ndikuwonetsetsa kuti ntchitoyo ndi yabwino. Ubwino wa chinthu sungathe kutsimikiziridwa kwathunthu poyesa kapangidwe kake.
Sizinthu zonse zonyansa zomwe zingadziwike ndipo sizinthu zonse zomwe zingathe kufufuzidwa. Choncho ubwino ukhoza kutsimikiziridwa ngati ndondomeko yonse yopangira ikuchitika mwatsatanetsatane komanso moyendetsedwa bwino. Ndi njira iyi yokha yomwe kupanga kumatsimikizira kuti mankhwala ali abwino. Njira yopangira imeneyi, yotchedwa Good Manufacturing Practice, ndiyofunikira pakupangira 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.
Pazamankhwala omwe amagwiritsidwa ntchito ndi anthu, malamulo ofunikira kwambiri ndi 1252/2014 ndi Directive 2003/94/EC. Pazamankhwala omwe amagwiritsidwa ntchito ngati Chowona Zanyama ndi Directive 91/412/EC yogwira ntchito. Pali malamulo ena okhudzana ndi malamulo omwe amayendetsa msika wamankhwala.
Zofunikira za GMP ndizofanana kwa anthu monga zamakampani azowona zanyama.Kutanthauzira kwa miyezo yomwe yakhazikitsidwa mulamulo ili, EudraLex imapereka chitsogozo. EudraLex ndi mndandanda wamalamulo omwe amagwira ntchito kumankhwala mkati mwa EU. Voliyumu 4 ya EudraLex ili ndi malamulo a GMP. Ndilo buku logwiritsa ntchito malangizo ndi mfundo za GMP. Malamulowa amagwira ntchito pamankhwala a anthu ndi nyama.
National
Unduna wa Zaumoyo, Ufulu ndi Masewera amasankha pamlingo wadziko lonse kuti chithandizo chamankhwala chingatumizedwe pansi pazifukwa ziti komanso zidziwitso zachipatala. The Medicines Act imalongosola momwe mankhwalawa amapangidwira, kugulitsidwa kwake ndi kugawa kwa wodwala. Mwachitsanzo The Opium Act imaletsa kukhala ndi mankhwala enaake olembedwa pamndandanda woyamba ndi ll wa Opium Act. Palinso lamulo pa ma precursors.
Malinga ndi malamulowa, ogulitsa mankhwala amatha kugulitsa ndi / kapena kugulitsa mankhwala omwe angagwiritsidwe ntchito popanga mankhwala kapena zophulika (zotsogolera) pansi pazifukwa zina. Palinso malamulo ndi malangizo monga malamulo a FMD (muyeso wotsutsana ndi chinyengo cha manambala amtundu) ndi malangizo a KNMP okhudza chisamaliro chamankhwala ndi Dutch Pharmacy Standard.
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 la chitsimikizo chamtundu. Mwambiri, chitsimikizochi, kuphatikiza pa GMP, chimaphatikizanso madera monga kapangidwe kazinthu ndi chitukuko cha zinthu. Chitsimikizo chaubwino ndi kuchuluka kwa zochitika zomwe ziyenera kuwonetsetsa kuti chinthu kapena ntchito ikugwirizana ndi zofunikira. Chitsimikizo chaubwino ndi chimodzi mwazinthu zofunika pakuwongolera zabwino. Kufunika koyendetsa bwino ndikofunikira. Mukangoganizira kwakanthawi zomwe zingachitike ngati zolakwa zidapangidwa popanga mankhwala ndipo zidapezeka mochedwa.
Kupatula kuzunzika kwa anthu, zitha kukhala tsoka kwa mbiri yamakampani opanga mankhwala. Kupanga kwabwino kumayang'ana pa zoopsa zomwe zimachitika pakupanga mankhwala, monga kuipitsidwa (kuipitsidwa kwa mankhwala amodzi ndi zigawo za mankhwala ena) ndi kusakaniza (zolakwika) zomwe zimachitika chifukwa cholemba molakwika.
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 ogwira ntchito, monga wamkulu wa zopanga ndi/kapena kuwongolera khalidwe ndi munthu wovomerezeka. Munthu wovomerezeka ali ndi udindo wowonetsetsa kuti njira zonse ndi mankhwala opangidwa ndi mankhwala amapangidwa ndikusamalidwa motsatira ndondomeko.
Amasaina (kwenikweni) pagulu lililonse la mankhwala ochokera kufakitale. Palinso woyang'anira wamkulu, yemwe ali ndi udindo woonetsetsa kuti katunduyo akukwaniritsa zofunikira zaulamuliro wa dziko pazinthu zamankhwala, popanda kuika odwala pangozi chifukwa chosowa chitetezo, khalidwe kapena mphamvu. Ziyenera kukhala zodziwikiratu, koma ndizofunikiranso kuti mankhwalawo ndi oyenerana ndi cholinga chomwe amapangira.
Kuyang'anira ndi GMP satifiketi
Ku Ulaya ndi kudziko lonse, pali ogwira ntchito 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 imachita kuyendera kwa opanga ku Netherlands kuti awone ngati akutsatira malamulo a GMP. Ngati malamulo a GMP sanakwaniritsidwe, wopanga sangakanidwe pa satifiketi ya GMP, komanso chilolezo chopanga. IGJ imayang'aniranso opanga m'maiko omwe ali kunja kwa European Union. Izi zimachitika molamulidwa ndi EMA ndi Medicines Evaluation Board (CBG).
Komanso pa pempho la Medicines Evaluation Board, IGJ imalangiza opanga muzolemba zovomerezeka zotsatsa (chilolezo chatsamba). Ngati wopanga sagwira ntchito molingana ndi zofunikira zamtundu wa GMP, Bungwe litha kusankha kuti wopanga uyu achotsedwe ku dossier ya chilolezo chotsatsa.
Bungweli limachita izi pokambirana ndi IGJ ndi mabungwe ena oyendera ku Europe ndi mabungwe aku Europe monga Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) ndi EMA. Ngati izi zingayambitse kusowa kwa mankhwala ku Netherlands, mwiniwake wovomerezeka wa malonda ayenera kunena izi ku Medicines Deficiencies and Defects Disclosure Office (Meldpunt geneesmidelen tekort en -defecten).
Zodzola komanso GMP
Kwa zodzoladzola, pali malamulo osiyana otsimikizira ubwino wawo. Pamlingo waku Europe pali Cosmetics Regulation 1223/2009/EC. Izi zimatsimikiziranso kuti zodzoladzola ziyenera kutsatira GMP. Malangizo omwe amagwiritsidwa ntchito pa izi ndi ISO 22916:2007 muyezo. Mulingo uwu uli ndi mfundo zoyambira za GMP zomwe zimayang'ana kwambiri makampani omwe amapanga zodzoladzola zomalizidwa. Uwu ndi mulingo wapadziko lonse lapansi ndipo wavomerezedwanso ndi European Committee for Standardization (CEN).
Ili ndi bungwe lokhazikika ku Europe lomwe limapanga miyezo yomwe ikufunika kwambiri. Kugwiritsa ntchito miyezo imeneyi sikokakamizidwa, koma kumawonetsa kumayiko akunja kuti malonda kapena ntchito zimakwaniritsa miyezo yabwino. Bungwe lokhazikika limapanganso 'miyezo yogwirizana' pofunsidwa ndi 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.
