Novɛmba 5, 2022
Ova di pas tɛn ia, di glob ɔl famasi sapɔt chen dɔn gɛt wan big chenj na di say we dɛn de — di API ɛn fɔmyulashɔn prodakshɔn we de bɔku we de muf frɔm Yurop ɛn Nɔt Amɛrika to Sawt Is Eshia (India, Indonishia, Tayland, Vietnam) ɛn Afrika (Ijipt, Sawt Afrika, Kenya, Nayjiria).
Ova di pas tɛn ia, di glob ɔl famasi sapɔt chen dɔn gɛt wan big chenj na di say we dɛn de — di API ɛn fɔmyulashɔn prodakshɔn we de bɔku we de muf frɔm Yurop ɛn Nɔt Amɛrika to Sawt Is Eshia (India, Indonishia, Tayland, Vietnam) ɛn Afrika (Ijipt, Sawt Afrika, Kenya, Nayjiria). Dis tren de drɛb bay di kɔst advantej ɛn di grow we lokal makit dɛn de gro.
Bɔt dis shift de briŋ kwaliti kɔmplians chalenj bak. Di ɔtoriti dɛn we de rigul na Yurop ɛn Amɛrika (lɛk FDA, EMA) se di mɛrɛsin dɛn we dɛn de import fɔ mit di sem prodakshɔn standad we di prɔdak dɛn we dɛn mek na di kɔntri gɛt. Dis min se fama ɛntapraiz dɛn na Sawt Is Eshia ɛn Afrika fɔ mek QC sistɛm dɛn we mit intanashɔnal standad, wit viskɔsiti tɛst we na wan impɔtant kɔmpɔnɛnt.
In spɔlayt ɔdit, di kɔmplians fɔ viskɔsiti tɛst data na tipikli wan ki fɔs. Di ɔditɔ dɛn de chɛk: Dɛn dɔn kalibrayt di viskomita? Di kalibreshɔn sɛtifiket valid? Dɛn dɔn validet di we aw dɛn de du di tɛst? Yu tink se dɛn kin tray fɔ no di tɛst data? Dɛn dɔn tren di wan dɛn we de du di wok? If yu nɔ gɛt bɛtɛ ansa to dɛn kwɛstyɔn ya, dat kin mek di ɔdit nɔ wok, ɛn i kin ivin afɛkt di prɔdak rɛjista na Yurop ɛn Amɛrika makit dɛn.
Fɔ mek wan GMP-kɔmpliant viskɔsiti tɛst sistɛm nid tri dimɛnshɔn: ikwipmɛnt, prɔses, ɛn pɔsin.
Ikwipmɛnt: Fɔs, di viskomita fɔ kalibrayt — i fayn fɔ yuz kalibreshɔn fluid dɛn ɛvri ia we dɛn kin tray fɔ no to di nashɔnal mɛtrɔlɔji standad dɛn (lɛk NIST-traceable silikon ɔyl). FangService in DVPlus+ siriɔs tɔchskrin viskomita inklud wan kalibreshɔn mɛmba fɛnshɔn we de ɔtomɛtik prompt we kalibreshɔn fɔ bi, we de mek ɔdit risk dɛn nɔ fɔgɛt kalibreshɔn. Sɛkɔn, di ikwipmɛnt fɔ gɛt data intɛgriti ficha dɛn — inklud yuz rayt manejmɛnt, ɔdit trel, data ɛnkripshɔn, ɛn tamper prɛvenshɔn. Di DVPlus+ siriɔs sɔpɔt 21 CFR Pat 11 kɔmplians, inklud ilɛktronik sayn, ɔdit treyl, ɛn data ɛkspɔt.
Prɔses: Dɛn fɔ mek standad ɔpreshɔn prosidyuz (SOP), we de difayn klia wan di opareshɔn rikwaymɛnt fɔ ɛni tɛst stɛp. SOP dɛn fɔ kɔba: fɔ pripia ɛn handle sampul, viskomita ɔpreshɔn stɛp, tɛst tɛmpracha kɔntrol, data rikodin ɛn ripɔt, ikwipmɛnt mentenɛns ɛn kalibreshɔn. FangService de gi lokal-langwej SOP tɛmplat fɔ Sawt Is Eshia ɛn Afrikan kɔstɔma dɛn, we de sɔpɔt Inglish, Frɛnch, Swahili, Indonishian, Tay, ɛn Vietnamese.
Di wan dɛn we de wok: Dɛn fɔ tren di wan dɛn we de du di wok ɛn asɛs dɛn se dɛn sabi du dɛn wok. Trenin fɔ kɔba: viskomita wok prinsipul, standad ɔpreshɔn prosidyuz, kɔmɔn fɔlt trɔbulshut, ɛn data intɛgriti ɔwe. FangService de gi ɔnlayn trenin kɔs ɛn lokal trenin savis, we de ɛp di ɔpreshɔn dɛn na Sawt Is Eshia ɛn Afrika ɛntapraiz dɛn fɔ masta kwik kwik wan di ɔpreshɔn skil dɛn we de fala di lɔ.
Insay GMP ɔdit, ‘analitikal mɛtɔd validɛshɔn’ fɔ di viskomita na impɔtant stɛp. Di rizin fɔ validɛshɔn na fɔ pruv se di viskomita, ɔnda spɛshal tɛst kɔndishɔn, kin kɔnsistɛntli prodyuz kɔrɛkt ɛn prɛsis rizɔlt. Valideshɔn paramita dɛn inklud: akkuracy, prɛsishɔn, linya rɛnj, ditekshɔn limit, ɛn robustnɛs.
Fɔ Sawt Is Eshia ɛn Afrika fama ɛntapraiz dɛm, viskomita validɛshɔn de gɛt spɛshal chalenj dɛm. Fɔ ɛgzampul, di lab dɛm na dɛn rijyɔn ya nɔ kin gɛt stebul tɛmpracha kɔntrol ɛnvayrɔmɛnt, we kin afɛkt di tɛst rizɔlt prɛsishɔn. FangService in NDJ-1E+ dijital rɔteshɔnal viskomita gɛt tɛmpracha prob ɛn ɔtomatik tɛmpracha kɔmpɛnshɔn, we de rikodɔ sampul tɛmpracha we dɛn de tɛst ɛn kɔrɛkt viskɔsiti ridin, we de ridyus di impak we tɛmpracha fluktueshɔn gɛt pan tɛst rizɔlt.
Dɔn bak, Sawt Is Eshia ɛn Afrika fama ɛntapraiz dɛn kin nɔ gɛt ɛkspiriɛns validɛshɔn injinia dɛn. FangService de gi wan ‘validɛshɔn savis pakej’ we inklud tɛst plan dizayn, tɛst ɛgzikishɔn, data rivyu, ɛn validɛshɔn ripɔt raytin, we de ɛp klaynt dɛn fɔ kɔmplit viskomita validɛshɔn. Wi validɛshɔn injinia dɛn gɛt bɔku GMP ɔdit ɛkspiriɛns ɛn dɛn sabi FDA, EMA, ɛn WHO ɔdit standad dɛn.
Piɔriɔdik viskomita kalibreshɔn na wan bɛsik GMP kɔmplians rikwaymɛnt. Bɔt na Sawt Is Eshia ɛn Afrika, fɔ gɛt traceable kalibreshɔn savis nɔ izi — mɛtrɔlɔjik infrastukchɔ na bɔku kɔntri dɛn nɔ de divɛlɔp, ɛn dɛn nɔ go ebul fɔ gi garanti fɔ di kalibreshɔn savis dɛn we de ɛn di rayt tɛm.
FangService dɔn mek wan kalibreshɔn savis nɛtwɔk na Sawt Is Eshia ɛn Afrika. Wi gɛt kalibreshɔn sɛnta dɛn na Bangkok, Jakata, Ho Chi Minh Siti, Nairobi, Lagos, ɛn Kairo, we gɛt NIST-traceable standad viskɔsiti fluid ɛn pɔshɔnal kalibreshɔn injinia dɛn. Wi de gi on-sayt kalibreshɔn ɛn sɛn-in kalibreshɔn savis mɔd, wit kalibreshɔn intaval we na 6 ɔ 12 mɔnt, ɛn kalibreshɔn sɛtifiket dɛn we dɛn kin tray fɔ tray fɔ fala intanashɔnal standad dɛn.
Fɔ ɛntapraiz dɛn we nɔ gɛt badjɛt, wi de gi bak ‘shɛri kalibreshɔn savis’ — bɔku ɛntapraiz dɛn kin jɔyn an fɔ bay kalibreshɔn savis fɔ sheb kɔst. Dis mכdel na patikyula wan we sכm εn midul saiz fama εntapraiz dεm na Sawt Is Eshia εn Afrika.
Apat frɔm dat, FangService in DVPlus+ siriɔs tɔchskrin viskomita de sɔpɔt ‘sɛlf-kalibreshɔn’ — di divays de ɔtomɛtik wan detekt spindl rɔteshɔn rɛsistɛns ɛn kɔmpia am agens bilt-in rɛfrɛns valyu dɛn, we de jenarayz sɛlf-kalibreshɔn ripɔt. Pan ɔl we sɛlf-kalibreshɔn nɔ kin ebul fɔ tek ples fɔ fɔmal ɛksternal kalibreshɔn, i de sav as ɔgzilari we fɔ kɔntrol kwaliti ɛvride, we de ɛp ɛntapraiz dɛn fɔ mek dɛn kɔntinyu fɔ gɛt kɔnfidɛns pan di ikwipmɛnt pefɔmɛns bitwin fɔmal kalibreshɔn dɛn.
Fɔ pripia fɔ di saplay ɔdit, Sawt Is Eshia ɛn Afrika fama ɛntapraiz dɛn fɔ pripia bifo tɛm:
Fɔs, mek shɔ se viskomita kalibreshɔn sɛtifiket dɛn valid ɛn dɛn kin tray fɔ no to intanashɔnal mɛtrɔlɔjik sistɛm dɛn. If yu de yuz FangService ikwipmɛnt, i kin izi fɔ dɔn kalibreshɔn tru wi kalibreshɔn savis nɛtwɔk.
Sɛkɔn, mek wan kɔmplit tɛst rɛkɔd sistɛm. Ɛni tɛst fɔ rikodɔ: sampul nem, batch nɔmba, tɛst de, tɛst tɛmpracha, viskɔsiti valyu, ɔpreshɔn sayn. Di DVPlus+ siriɔs in tɔchskrin intafɛs ɛn data ɛkspɔt fɛnshɔn de mek dis prɔses simpul.
Tɔd, pripia SOP ɛn trenin rɛkɔd. SOP dɛn fɔ kɔba ɔl di we dɛn we dɛn kin yuz fɔ tɛst di viskɔsiti, ɛn di trenin rɛkɔd dɛn fɔ gɛt di de dɛn we di ɔpreshɔn de tren, di tin dɛn we de insay di trenin, ɛn di rizɔlt dɛn we dɛn kin asɛs.
Fɔs, fɔ du intanɛnt ɔdit ɔltɛm. Intanɛt ɔdit na di bɛst we fɔ no di prɔblɛm dɛn we kin apin we pɔsin de fala di lɔ. Wi rikɔmɛnd fɔ du intanɛnt ɔdit ɛvri kwata, chɛk viskomita ɔpreshɔn stetɔs, kɔmplitnɛs fɔ tɛst rɛkɔd, ɛn SOP ɛgzikishɔn.
FangService de gi wan ‘GMP Kɔmplians Pakɛj’ fɔ Sawt Is Eshia ɛn Afrika fama ɛntapraiz dɛn, we inklud: viskomita sɛlɛkshɔn rɛkɛmɔndeshɔn, kalibreshɔn savis, SOP tɛmplat, ɔpreshɔnal trenin, ɛn intanɛnt ɔdit sɔpɔt. Wi gol na fɔ ɛp ɛntapraiz dɛn fɔ mek QC sistɛm dɛn we de mit intanashɔnal standad dɛn insay badjɛt kɔnstrakshɔn, fɔ mek shɔ se dɛn pas di saplay ɔdit dɛn fayn fayn wan. View the Viscosity Measurement Instruments Collection
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