Kubva payakaparurwa muna 1992, "Good Manufacturing Practice for Drugs" (GMP) muindasitiri yemishonga yeChina yave kuzivikanwa zvishoma nezvishoma, kugamuchirwa, uye kuitwa nemabhizinesi ekugadzira mishonga.GMP inyika inosungirwa mutemo kumabhizinesi, uye mabhizinesi anotadza kuzadzisa zvinodiwa mukati menguva yakatarwa anozomira kugadzira.
Iyo yakakosha yemukati yeGMP certification ndiyo yemhando yekutonga kutonga kwekugadzirwa kwezvinodhaka.Zvirimo zvinogona kupfupikiswa kuita zvikamu zviviri: software management uye hardware zvivakwa.Chivako chekamuri chakachena ndechimwe chezvinhu zvakakura zvekudyara muzvivakwa zvehardware.Mushure mekupedzwa kweimba yakachena chivakwa, ingave ichikwanisa kuzadzisa zvinangwa zvekugadzira uye kusangana neGMP zvinodiwa zvinofanirwa kusimbiswa kuburikidza nekuyedzwa.
Mukati mokuongororwa kwekamuri rakachena, vamwe vavo vakakundikana kunzverwa kworucheno, vamwe vaiva vomunzvimbomo kufekitari, uye vamwe vakanga vari basa rose.Kana kuongorora kwacho kusingakodzeri, kunyangwe mapato ese ari maviri akawana zvinodiwa kuburikidza nekugadzirisa, kugadzirisa, kuchenesa, nezvimwewo, kazhinji inoparadza akawanda evashandi uye zviwanikwa zvekushandisa, inononoka nguva yekuvaka, uye inonoke maitiro eGMP certification.Zvimwe zvikonzero nekukanganisika zvinogona kudzivirirwa zvisati zvaongororwa.Mubasa redu chairo, takaona kuti zvikonzero zvikuru uye matanho ekuvandudza ehutsanana husina kukodzera uye kutadza kweGMP zvinosanganisira:
1. Kusanzwisisika kwekugadzira engineering
Ichi chiitiko hachishamisi, kunyanya mukuvakwa kwemakamuri madiki akachena ane hutsanana hunodiwa.Makwikwi einjiniya yekamuri yakachena anotyisa izvozvi, uye mamwe mayuniti ekuvaka akapa makotesheni akaderera mumabhedha avo kuti vawane chirongwa.Muchikamu chekupedzisira chekuvaka, mamwe mayuniti akashandiswa kucheka makona uye kushandisa yakaderera simba air conditioning uye ventilation compressor units nekuda kwekushaiwa kwavo ruzivo, zvichikonzera kusapindirana kwemagetsi ekupa uye nzvimbo yakachena, zvichikonzera hutsanana husina kukodzera.Chimwe chikonzero ndechekuti mushandisi akawedzera zvinodiwa zvitsva uye nzvimbo yakachena mushure mekugadzirwa uye kutanga kwekuvaka, izvo zvichaitawo kuti dhizaini yepakutanga isakwanise kuzadzisa zvinodiwa.Uku kukanganisa kwekuzvarwa kwakaoma kuvandudza uye kunofanirwa kudzivirirwa panguva yekugadzira engineering chikamu.
2. Kutsiva zvigadzirwa zvepamusoro nezvigadzirwa zvakaderera
Mukushandiswa kwemasefa ehepa mumakamuri akachena, nyika inotara kuti pakucheneswa kwemweya nechiyero chehutsanana chinosvika 100 000 kana pamusoro panofanira kushandiswa masefa matatu epuraimari, epakati, nehepa.Munguva yekusimbisa maitiro, zvakaonekwa kuti hombe yakachena yekamuri purojekiti yakashandisa sub hepa air sefa kutsiva iyo hepa air sefa pahutsanana pamwero we10000, zvichikonzera kuchena kusingakodzeri.Chekupedzisira, iyo yepamusoro-inoshanda sefa yakatsiviwa kuti isangane nezvinodiwa zveGMP certification.
3. Kuvharwa kwakashata kwemhepo yekufambisa duct kana sefa
Ichi chiitiko chinokonzerwa nekuvakwa kwakashata, uye panguva yekugamuchirwa, zvingaita sekuti imwe kamuri kana chikamu chegadziriro imwechete haina kukodzera.Iyo nzira yekuvandudza ndeye kushandisa iyo yekuvuza yekuyedza nzira yemhepo yekugovera duct, uye sefa inoshandisa cheki counter kuti itarise chikamu-chikamu, yekuisa chisimbiso, uye yekuisa furemu yefirita, ratidza nzvimbo yekuvuza, uye nekunyatsoisa chisimbiso.
4. Kusagadzikana kwekugadzira uye kutumirwa kwekudzoka kwemhepo ducts kana mhepo yemhepo
Panyaya yezvikonzero zvekugadzira, dzimwe nguva nekuda kwekumisikidzwa kwenzvimbo, kushandiswa kwe "top supply side return" kana kuti kusakwana kwenhamba yekudzosa mhepo yemhepo haigoneki.Mushure mekubvisa zvikonzero zvekugadzira, iyo debugging yekudzoka mhepo mavhavha zvakare yakakosha yekuvaka link.Kana iyo debugging isiri yakanaka, kushorwa kwemhepo yekudzoka kwakakwira zvakanyanya, uye huwandu hwemhepo hwekudzoka hushoma pane huwandu hwemhepo hwekupa, huchakonzerawo hutsanana husina kukodzera.Mukuwedzera, kureba kwemhepo yekudzoka kubva pasi panguva yekuvaka kunobatawo utsanana.
5. Kusakwana kuzvinatsa nguva yekuchenesa kamuri system panguva yekuyedzwa
Zvinoenderana nechiyero chenyika, kuedza kwekuyedza kuchatangwa maminetsi makumi matatu mushure mekuchenesa mhepo yekufefetera system kushanda zvakajairika.Kana nguva yekumhanya yakanyanyisa, inogona kukonzera kuchena kusina kukodzera.Muchiitiko ichi, zvakakwana kuwedzera nguva yekushanda yemhepo yekuchenesa mhepo zvakakodzera.
6. Kucheneswa kwemhepo yemhepo haina kucheneswa zvakakwana
Munguva yekuvaka, iyo yose yekuchenesa air conditioning system, kunyanya kugovera uye kudzorera mhepo ducts, haisati yapedzwa mune imwe kuenda, uye vashandi vekuvaka uye nharaunda yekuvaka inogona kukonzera kusvibiswa kune ventilation ducts uye mafirita.Kana isina kucheneswa zvakakwana, inokanganisa zvakananga mhinduro dzebvunzo.Chiyero chekuvandudza ndechekuchenesa paunenge uchivaka, uye mushure mekunge chikamu chekare chekuisa pombi chanyatsocheneswa, firimu repurasitiki rinogona kushandiswa kuisimbisa kudzivirira kusvibiswa kunokonzerwa nemamiriro ekunze.
7. Wekishopu yakachena isina kunyatsocheneswa
Pasina kupokana, wekishopu yakachena inofanirwa kunyatsocheneswa bvunzo isati yaenderera.Inoda kuti vashandi vekupukuta kwekupedzisira vapfeke hembe dzebasa dzakachena dzekuchenesa kubvisa kusvibiswa kunokonzerwa nemuviri wemunhu wevanochenesa.Mishonga yekuchenesa inogona kuva mvura yepombi, mvura yakachena, organic solvents, neutral detergents, etc. Kune avo vane anti-static zvinodiwa, pukuta zvakakwana nejira rakanyikwa mu anti-static liquid.
Nguva yekutumira: Jul-26-2023