Viscosity Compliance in Pharma Supply Chains: Furakɛlaw ka jatebɔ ani jogoɲini SEA ni Afiriki baarakɛdabaw ye

Sariyasen

Nowanburukalo tile 5, san 2022

San tan tɛmɛnenw kɔnɔ, diɲɛ furakɛlitɔnba ye fɛnba sɔrɔ dugukoloko siratigɛ la — API ni furakɛlifɛnw bɔli cayara ka bɔ Erɔpu ani Ameriki Woroduguyanfan na ka taa Azi Saheli-Kɔrɔn fɛ (Ɛndi, Ɛndonezi, Tayilandi, Wiyetnam) ani Afiriki (Misira, Afiriki tilebinyanfan, Kenya, Nizeriya).

Supply Chain Shift ani sariya labatoli tansiyɔn kan Viscosity Testing kan

San tan tɛmɛnenw kɔnɔ, diɲɛ furakɛlitɔnba ye fɛnba sɔrɔ dugukoloko siratigɛ la — API ni furakɛlifɛnw bɔli cayara ka bɔ Erɔpu ani Ameriki Woroduguyanfan na ka taa Azi Saheli-Kɔrɔn fɛ (Ɛndi, Ɛndonezi, Tayilandi, Wiyetnam) ani Afiriki (Misira, Afiriki tilebinyanfan, Kenya, Nizeriya). O cogoya in bɛ bɔ musaka nafaw la ani sigida suguw bonya fɛ.

Nka, o jiginni in fana bɛ na ni gɛlɛyaw ye sariya labatoli ɲuman na. Erɔpu ni Ameriki jamanaw ka sariyatigiw (i n’a fɔ FDA, EMA) b’a ɲini fura minnu bɛ na jamana wɛrɛw la, olu ka se ka u dilanni sariyaw labato ni jamana kɔnɔ furaw ye. O kɔrɔ ye ko furakɛlitɔn minnu bɛ Azi saheli-kɔrɔn fɛ ani Afiriki, olu ka kan ka QC sigidaw sigi senkan minnu bɛ bɛn diɲɛ sariyaw ma, ni sɔgɔsɔgɔninjɛ sɛgɛsɛgɛli ye fɛn ye min nafa ka bon kosɛbɛ.

Fɛn dilanbagaw ka jateminɛw na, a ka c’a la, fɛnɲɛnamafagalanw sɛgɛsɛgɛli kunnafoniw labatoli ye fɛnba ye. Jateminɛbagaw bɛ sɛgɛsɛgɛli kɛ: Yala viskomɛtiri jateminɛna wa? Yala kalibreli seere bɛ se ka kɛ wa? Yala sɛgɛsɛgɛli kɛcogo tiɲɛna wa? Yala sɛgɛsɛgɛli kunnafoniw bɛ se ka tugu ɲɔgɔn kɔ wa? Yala baarakɛlaw degecogo kɛra wa? Nin ɲininkali ninnu jaabi bɛrɛ tɛ se ka kɛ sababu ye ka jatebɔ dɛsɛ, wa hali ka nɔ bila fɛnw sɛbɛnni na Erɔpu ni Ameriki suguw la.

GMP-Compliant Viscosity Testing System sigili: Minɛnw, taabolo ani baarakɛlaw

GMP-ka kɛɲɛ ni viskositɛri sɛgɛsɛgɛli sira sigili ye, o bɛ fɛn saba de wajibiya: minɛnw, taabolo ani baarakɛlaw.

Minɛnw : Fɔlɔ, viskomɛtiri ka kan ka jateminɛ — a ka fisa san o san ka baara kɛ ni jateminɛjiw ye minnu bɛ se ka tugu jamana ka jateminɛ sariyaw la (i n’a fɔ silikɔni tulu min bɛ se ka tugu NIST fɛ). FangService ka DVPlus+ series touchscreen viscometer kɔnɔ, calibration hakilijigin baarakɛcogo dɔ bɛ yen min bɛ a yɛrɛ ɲininka ni calibration ka kan ka kɛ, o bɛ audit faratiw bali ka bɔ calibrations ɲinɛnenw na. Filanan, minɛnw ka kan ka kɛ ni kunnafonidilanw dafalen ye — i n’a fɔ baarakɛlaw ka josariyaw ɲɛnabɔli, jatebɔ siraw, kunnafoniw sirili, ani fɛnw tiɲɛni balili. DVPlus+ seriyali bɛ CFR tilayɔrɔba 11 labatoli 21 dɛmɛ, i n’a fɔ ɛntɛrinɛti bolonɔbila, jatebɔ siraw, ani kunnafoniw bɔli.

Taabolo : Baarakɛcogo jɔnjɔnw (SOP) ka kan ka sigi sen kan, ka baarakɛcogo wajibiyalenw ɲɛfɔ ka jɛya sɛgɛsɛgɛli senfɛta kelen-kelen bɛɛ la. SOPw ka kan ka ɲɛsin : misali labɛnni n’a minɛcogo, viskomɛtiri baarakɛcogo, sɛgɛsɛgɛli funteni kɔlɔsili, kunnafoniw sɛbɛnni ni u lakali, minɛnw ladonni ni u jateminɛni. FangService bɛ sigidakan SOP misaliw di Azi saheli-kɔrɔnfɛla ni Afiriki kiliyanw ma, ka Angilɛkan, Faransikan, Swahilikan, Ɛndonezikan, Tayilandikan ani Vietnamkan dɛmɛ.

Baarakɛlaw: Baarakɛlaw ka kan ka dege ani ka jateminɛ kɛ ko u bɛ se kosɛbɛ. Kalan ka kan ka ɲɛsin : viskomɛtiri baarakɛcogo sariyakolow ma, baarakɛcogo jɔnjɔnw, filiw ɲɛnabɔli minnu bɛ kɛ tuma bɛɛ, ani kunnafoniw dafalen dɔnni. FangService bɛ kalan kɛ ɛntɛrinɛti kan ani sigida kalanko baaradaw, ka baarakɛlaw dɛmɛ minnu bɛ Azi saheli-kɔrɔnfɛla ni Afiriki baarakɛdabaw kɔnɔ, u ka se ka baarakɛcogo dɔn joona minnu bɛ sariyaw labato.

Viscomètre validation et confirmation: Fɛnba minnu bɛ kɛ jatebɔw la

GMP jatebɔw la, ‘sɛgɛsɛgɛli fɛɛrɛ tiɲɛni’ viskomɛtiri kama, o ye fɛɛrɛ kɔrɔba ye. Tiɲɛni kun ye k’a jira ko viskomɛtiri, sɛgɛsɛgɛli kɛcogo kɛrɛnkɛrɛnnenw na, a bɛ se ka jaabi tigitigiw ni tigitigiw di tuma bɛɛ. Tiɲɛni paramɛtiriw ye : tiɲɛni, tiɲɛni, ɲɔgɔndan sinsinni, dɔnni dan, ani barika.

Azi saheli-kɔrɔnfɛla ni Afiriki furakɛlitɔnw fɛ, viskomɛtiri tiɲɛni bɛ gɛlɛya kɛrɛnkɛrɛnnenw sɔrɔ. Misali la, laboratuwari minnu bɛ o maraw kɔnɔ, a bɛ se ka kɛ ko funteni kɔlɔsili sigida sabatilenw tɛ yen, o bɛ nɔ bila sɛgɛsɛgɛli jaabiw tiɲɛni na. FangService ka NDJ-1E+ nizɛri jiginni sɛgɛsɛgɛlikɛlan bɛ ni funteni sɛgɛsɛgɛlikɛlan ye ani funteni musaka hakɛ otomatiki, ka misali funteni sɛbɛn sɛgɛsɛgɛli senfɛ ani ka sɔgɔsɔgɔninjɛ kalanni latilen, o bɛ dɔ bɔ funteni jiginni nɔ na sɛgɛsɛgɛli jaabiw la.

Ka fara o kan, Azi saheli-kɔrɔnfɛla ni Afiriki furakɛlitɔnw tɛ ni sɛgɛsɛgɛlikɛla ŋanaw ye minnu bɛ se kosɛbɛ. FangService bɛ ‘sɛgɛsɛgɛli baarabolodalen’ dɔ di min kɔnɔ, sɛgɛsɛgɛli bolodacogo, sɛgɛsɛgɛli waleyali, kunnafoniw lajɛli, ani dantigɛli rapɔɔri sɛbɛnni, ka kiliyanw dɛmɛ ka viskomɛtiri tiɲɛni dafa. An ka dantigɛli injiniyɛriw ka GMP jatebɔ dɔnniya ka bon ani u bɛ FDA, EMA ani OMS ka jatebɔ sariyaw dɔn.

Calibration Service Network Azi saheli-kɔrɔn fɛ ani Afiriki

Viskomɛtiri jateminɛni waati ni waati ye GMP sariya labatoli wajibiyalen jɔnjɔn ye. Nka, Azi saheli-kɔrɔnfɛla ni Afiriki, ka jatebɔ baara minnu bɛ se ka tugu ɲɔgɔn kɔ, olu sɔrɔli man nɔgɔn — jateminɛko siratigɛ la jamana caman na, olu ma yiriwa, wa jateminɛ baara sɔrɔli n’a waati bɛnnen tɛ se ka dafa.

FangService ye jateminɛ baarakɛyɔrɔ dɔ sigi senkan Azi saheli-kɔrɔn fɛ ani Afiriki. An bɛ ni jateminɛyɔrɔw ye Bangkok, Jakarta, Ho Chi Minh dugu, Nayirobiyi, Lagos ani Kayira, minnu bɛ ni NIST-traceable standard viscosity fluids ye ani calibration engineers professionnels. An bɛ jateminɛ kɛcogoyaw di yɔrɔ la ani jateminɛ kɛcogo minnu bɛ ci, ni jateminɛ kɛcogo ye kalo 6 walima kalo 12 ye, ani jateminɛsɛbɛnw minnu bɛ se ka tugu diɲɛ sariyaw kɔ.

Baarakɛda minnu ka baarakɛnafolo dan ye, an bɛ ‘jateminɛ kɛcogo jɛlenw’ fana di — baarakɛda caman bɛ se ka jateminɛ kɛcogo san ɲɔgɔn fɛ walasa ka musakaw tila ɲɔgɔn na. Nin misali in ka di kɛrɛnkɛrɛnnenya la furakɛlitɔn fitininw ni cɛmancɛw fɛ Azi saheli-kɔrɔnfɛla ni Afiriki.

Ka fara o kan, FangService ka DVPlus+ seriyali touchscreen viscometer bɛ ‘yɛrɛlabɔli’ dɛmɛ — minɛn in bɛ spindle jiginni kunbɛncogo dɔn a yɛrɛma, k’a suma ni jateminɛ nafaw ye minnu bɛ a kɔnɔ, o bɛ yɛrɛlabɔli rapɔɔri dɔ lawuli. Hali n’a y’a sɔrɔ yɛrɛlajɛ tɛ se ka kɛ kɛnɛma jateminɛ kɛcogo kɔrɔ nɔ na, ​​a bɛ kɛ fɛɛrɛ dɛmɛnan ye don o don jogoɲini na, ka baarakɛda ninnu dɛmɛ u ka da u yɛrɛ la minɛnw baaracogo la jateminɛ kɛcogo labɛnnenw ni ɲɔgɔn cɛ.

Ladilikan nafamaw: Ka i labɛn ka ɲɛsin feerekɛlaw ka jatebɔw ma

Walasa ka labɛn kɛ feerekɛlaw ka jateminɛw kama, Azi saheli-kɔrɔnfɛla ni Afiriki furakɛlitɔnw ka kan ka kɔn ka u labɛn:

Fɔlɔ, aw k’a lajɛ ko viskomɛtiri jateminɛ seereyaw bɛ se ka kɛ, wa u bɛ se ka tugu diɲɛ jateminɛ siratigɛw la. Ni baara bɛ kɛ ni FangService minɛnw ye, jateminɛ bɛ se ka ban nɔgɔya la an ka jateminɛ baarakɛyɔrɔ rezo fɛ.

Filanan, aw bɛ sɛgɛsɛgɛli sɛbɛncogo dafalen dɔ sigi sen kan. Kɔrɔbɔli kelen-kelen bɛɛ ka kan ka sɛbɛn: misali tɔgɔ, kulu nimɔrɔ, sɛgɛsɛgɛli don, sɛgɛsɛgɛli funteni, a sɔgɔli hakɛ, baarakɛla bolonɔbila. DVPlus+ seriyali ka touchscreen interface ani data export baarakɛcogo bɛ nin baara in nɔgɔya.

Sabanan, ka SOPw ni kalan sɛbɛnw labɛn. SOPw ka kan ka ɲɛsin fɛnɲɛnamafagalanw sɛgɛsɛgɛli fɛɛrɛw bɛɛ ma minnu bɛ kɛ tuma caman na, ani kalan sɛbɛnw ka kan ka kɛ baarakɛlaw ka kalan donw ye, kalan kɔnɔkow, ani jateminɛ jaabiw.

Naaninan, ka kɔnɔna jateminɛw kɛ tuma bɛɛ. Kɔnɔna jateminɛw ye fɛɛrɛ ɲuman ye walasa ka sariya labatoli koɲɛw dɔn minnu bɛ se ka kɛ. An b’a ɲini aw fɛ aw ka kɔnɔna jateminɛ kɛ kalo saba o kalo saba, ka viskomɛtiri baarakɛcogo lajɛ, ka sɛgɛsɛgɛli sɛbɛnw dafalenw lajɛ, ani ka SOP waleyali lajɛ.

FangService bɛ ‘GMP sariya labatoli foroko’ di Azi saheli-kɔrɔnfɛla ni Afiriki furakɛlitɔnw ma, i n’a fɔ : viskomɛtiri sugandili ladilikanw, jateminɛ baaradaw, SOP misaliw, baarakɛcogo kalanni, ani kɔnɔna jateminɛ dɛmɛni. An ka laɲini ye ka baarakɛdabaw dɛmɛ ka QC sigidaw sigi senkan minnu bɛ diɲɛ sariyaw dafa baarakɛnafolo gɛlɛyaw kɔnɔ, ka a to feerekɛlaw ka jateminɛw tɛmɛna ka ɲɛ. View the Viscosity Measurement Instruments Collection