Ɗooftagol viskosite e nder njuɓɓudi ñamri Pharma : ƴeewndo ñamri e ƴeewndo kalite wonande SEA e gollorɗe Afrik

Ayaare

Ñalnde 5 noowammbar 2022

E nder duuɓi sappo jawtuɗi ɗii, njuɓɓudi ñameele winndere ndee waɗii waylo-waylo weeyo ngo — ɓeydagol peewnugol API e formulaaji ummoraade Orop e Amerik worgo feewde Asii fuɗnaange-rewo (Inndo, Indoneesi, Taylande, Vietnam) e Afrik (Ejipt, Afrik worgo, Keñiya, Nijeer).

Shift Chain Supply e Ɓooygol ɗooftaare e jarribooji Viscosity

E nder duuɓi sappo jawtuɗi ɗii, njuɓɓudi ñameele winndere ndee waɗii waylo-waylo weeyo ngo — ɓeydagol peewnugol API e formulaaji ummoraade Orop e Amerik worgo feewde Asii fuɗnaange-rewo (Inndo, Indoneesi, Taylande, Vietnam) e Afrik (Ejipt, Afrik worgo, Keñiya, Nijeer). Ndee feere ina addana nafooje coggu e ɓeydagol luumooji nokkuuji ɗii.

Kono kadi ngool waylo-waylo ina addana en caɗeele ɗooftaare kalite. Laamuuji toppitiiɗi ko fayti e Orop e Amerik (hono FDA, EMA) ina ɗaɓɓi nde leɗɗe naatnaaɗe ɗee njogori yahdude e tolnooji peewnugol ko wayi no geɗe peewnaaɗe e nder leydi ndii. Ɗum firti ko gollorɗe farmasii e nder Asii fuɗnaange-rewo e Afrik ina poti sosde njuɓɓudi QC jowitiindi e tolnooji winndereeji, tawa jarribo viscosity ko huunde nde alaa ko waawi heen wonde.

E nder ƴeewndorɗe dokkoowo, ɗooftaare dokke jarribooje viscosity ko huunde tiiɗnde. Auditeurs ƴeewtotoo : Mbele viskomeeter oo kalibraama ? Mbele seedantaagal kalibraasiyoŋ ina selli? Mbele feere jarribo ndee ina selli? Mbele dokke jarribooje ɗee ina mbaawi rewde? Mbele operateeruuji ɗii njannginaama ? Jaabawol ngol ŋakkaani e ɗee naamne ina waawi addande ɗum ŋakkeende ƴeewndo, haa arti noon e binnditagol geɗe e nder luumooji Orop e Amerik.

Sosde Siistem jarriborɗo ɓuuɓri gonndi e GMP : kaɓirɗe, golle, e gollotooɓe

Sosde njuɓɓudi jarribordi ɓuuɓri ndi GMP ina ɗaɓɓi geɗe tati : kaɓirɗe, golle, e gollotooɓe.

Kaɓirɗe : Ko adii fof, viskomeeter ina foti kalibreede — ko ɓuri moƴƴude ko hitaande kala huutoraade ndiyam kalibraasiyoŋ rewindaaɗam e tolnooji metroloji ngenndiiji (hono nebam silikon rewindaaɗam e NIST). FangService's DVPlus+ series touchscreen viscometer ina waɗi gollal siftorde kalibraasiyoŋ, ngal ƴettata otomatik so kalibraasiyoŋ oo fotii, haɗata baasal ƴeewndo e kalibraasiyoŋaaji yejjittaaɗi. Ɗiɗaɓere, kaɓirɗe ɗee ina poti jogaade geɗe laaɓtuɗe — ina heen njuɓɓudi hakkeeji kuutortooɗo, laabi ƴeewndo, sifirde dokke, e haɗde mbayliigu. Sereeji DVPlus+ ina mballita e ɗooftaade 21 CFR Part 11, ina heen siynooji elektoronik, laabi ƴeewndo, e yaltinde dokke.

Laawol : Laabi gollorɗi (SOPs) ina poti tabitineede, tawa ina laaɓti sarɗiiji gollorɗi e kala daawal jarriborgal. SOP ina foti huutoraade : peewnugol e jokkondire eɓɓooje, laabi gollal viskometer, ƴeewndo nguleeki jarribo, winndugol e humpitooji, toppitagol kaɓirɗe e kalibraasiyoŋ. FangService ina rokka mbaydiiji SOP e ɗemɗe nokkuuje ngam soodooɓe Asii fuɗnaange-rewo e Afrik, ina wallita Engele, Farayse, Suwahili, Indoneesi, Taylande, e Vietnam.

Gollotooɓe : Gollotooɓe ina poti janngeede e ƴeewteede no mbaawirta. Heblo ngoo ina foti huutoraade : kuule golle viskometer, laabi gollorɗi kuuɓtodinɗi, ƴeewndo caɗeele keewɗe, e humpito nuunɗal dokke. FangService ina rokka janngirɗe janngirɗe e internet e sarwisaaji janngirɗe nokkuuji, ina wallita gollotooɓe e nder gollorɗe Asii fuɗnaange-rewo e Afrik ngam yaawde humpitaade karallaagal gollal jowitiingal e jamirooje.

Sifaa e tabitingol Viskometer : Ɗaɓɓaaɗe teeŋtuɗe e nder ƴeewndorɗe

E nder ƴeewndorɗe GMP, ‘validation méthode analytique’ wonande viskomeeter ko huunde tiiɗnde. Faandaare ƴeewndo ngoo ko hollirde wonde viskomeeter oo, e nder sarɗiiji jarribooji keertiiɗi, ina waawi waɗde e kala sahaa njeñtudi laaɓtundi e laaɓtundi. Parametruuji jaɓgol ina mbaɗi : laaɓal, laaɓal, njuuteendi doggol, keerol yiytugol, e semmbe.

Wonande gollorɗe farmasiiji Asii fuɗnaange-rewo e Afrik, ƴeewndo viskometer ina jogii caɗeele keewɗe. Yeru, laboratuwaaruuji e nder ɗeen diiwanuuji ina mbaawi waasde jogaade nokkuuji ɗo nguleeki dartii, ina battina e laaɓal njeñtudi jarribo. FangService's NDJ-1E+ viscometer rotational digital ina waɗi sonndu nguleeki e mbayliigu nguleeki otomatik, ina winnda nguleeki sample e nder jarribo e feewnude jaŋte nguleeki, ina usta batte mbayliigu nguleeki e njeñtudi jarribo.

Yanti heen, gollorɗe farmasiiji Asii fuɗnaange-rewo e Afrik ina keewi waasde inɗeele laaɓtuɗe. FangService ina rokka ‘package service de validation’ ina waɗi peewnugol peeje jarribooje, golle jarribooje, ƴeewndo dokke, e binndol ciimtol teskuyaaji, wallitde kiliyaneeɓe timminde teskuyaaji viskometer. Injiniyankooɓe men ngam tabitinde ina njogii humpitooji keewɗi e ƴeewndo GMP, ina nganndi kadi FDA, EMA, e OMS ƴeewndo tolnooji.

Reso sarwisaaji kalibraasiyoŋ to Asii fuɗnaange-rewo e Afrik

Kalibraasiyoŋ viskomeeter sahaa e sahaa fof ko huunde nde GMP foti rewde. Kono noon, e nder Asii fuɗnaange-rewo e Afrik, heɓde sarwisaaji kalibraasiyoŋ rewindaade ɗum weeɓaani — njuɓɓudi metroloji e nder leyɗeele keewɗe ina ŋakki ƴellitaade, tee keɓgol e sahaa sarwisaaji kalibraasiyoŋ ɗii mbaawataa dañeede.

FangService sosi lowre sarwisaaji kalibraasiyoŋ e nder Asii fuɗnaange-rewo e Afrik. Min njogii nokkuuji kalibraasiyoŋ to Bangkok, Jakarta, Ho Chi Minh, Nairobi, Lagos, e Kayhayɗi, jogiiɗi ndiyam ɓuuɓɗam gonɗam e NIST e inɗeele kalibraasiyoŋ karallaagal. Min ndokka kalibraasiyoŋ e nokkuure e mbaadiiji sarwiis kalibraasiyoŋ nelduɗo, e hakkunde kalibraasiyoŋ lebbi 6 walla 12, e seedanteeje kalibraasiyoŋ jokkondirɗe e tolnooji winndereeji.

Wonande gollorɗe ɗe ngalaa bidsee, min ndokka kadi ‘sarwisaaji kalibraasiyoŋ renndini’ — gollorɗe keewɗe ina mbaawi renndude soodde sarwisaaji kalibraasiyoŋ ngam renndinde njoɓdi. Ooɗoo sifaa ina teskaa e nder gollorɗe farmasi tokoose e hakkundeeje e nder Asii fuɗnaange-rewo e Afrik.

Yanti heen, FangService’s DVPlus+ series touchscreen viscometer ina wallita ‘kalibraasiyoŋ hoore mum’ — kaɓirgal ngal ina yiytoo otomatikk reentaade yirlaade spindle, ina renndina ɗum e nafooje tuugnorgal mahraaɗe, ina addana ɗum ciimtol kalibraasiyoŋ hoore mum. So tawii kalibraasiyoŋ hoore mum waawaa lomtaade kalibraasiyoŋ yaajɗo njuɓɓudi, ina waɗi feere wallitnde ngam ƴeewtaade kalite ñalnde kala, wallita gollorɗe jogaade hoolaare e golle kaɓirɗe hakkunde kalibraasiyoŋ njuɓɓudi.

Wasiyaaji kuuɓtodinɗi: Peewnugol ƴeewndorɗe (audits) jolngooji

Ngam heblude ƴeewndorɗe (audit) jolngooji, gollorɗe farmasiiji Asii fuɗnaange-rewo e Afrik ina poti heblude ko adii :

Ko adii fof, ƴeewtaade seedanteeje kalibraasiyoŋ viskomeeter ina ngoodi, ina mbaawi rewde e njuɓɓudiiji metroloji winndereeji. So tawii ko kaɓirɗe FangService, kalibraasiyoŋ ina waawi timmineede e no feewi rewrude e lowre men sarwiis kalibraasiyoŋ.

Ɗiɗaɓere, sosde njuɓɓudi ƴeewndo timmundi. Kala jarribo ina foti winndude : innde sample, limoore batte, ñalngu jarribo, nguleeki jarribo, teddeendi ɓuuɓri, siyno golloowo. Koolaaɗo kuuɓal DVPlus+ series e gollal yaltinnde dokke ina mbaɗa ngalɗoo gollal ko weeɓngal.

Tataɓol, peewnugol SOP e binndanɗe heblo. SOPs ina poti huutoraade denndaangal laabi jarribooji vurzi waawde huutoreede, e binndanze heblo ina poti jogaade ñalɗi heblo golloowo, loowdi heblo, e njeñtudi wizto.

Nayaɓo, waɗde ƴeewndorɗe ndernderiije ko juuti. Ko ƴeewndo nder leydi woni feere ɓurnde moƴƴude ngam anndude caɗeele potɗe ɗooftaade. Min mbasiyii waɗde ƴeewndo ndernderiijo kala lewru, ƴeewtaade ngonka golle viskometer, timmal binndanɗe jarribooje, e golle SOP.

FangService ina rokka ‘Package Compliance GMP’ wonande gollorɗe farmasiiji Asii fuɗnaange-rewo e Afrik, ina heen : wasiyaaji suɓagol viskometer, sarwisaaji kalibraasiyoŋ, nate SOP, heblo golle, e ballal ƴeewndo ndernderi. Faandaare amen ko wallude gollorɗe sosde njuɓɓudi QC jowitiindi e tolnooji winndereeji e nder caɗeele bidsee, ngam tabitinde yahdu moƴƴundu e ƴeewndorɗe dokkoowo. View the Viscosity Measurement Instruments Collection