Viscosity Compliance wɔ Pharma Supply Chains mu: Supplier Auditing ne Quality Assurance ma SEA ne Afrika Nnwumakuw

Atwerɛ

Ɔberɛfɛw da 5, afe 2022

Wɔ mfeɛ du a atwam no mu no, wiase nyinaa nnuru a wɔde ma no anya nsakraeɛ kɛseɛ wɔ asasesin mu — API ne nnuru a wɔde yɛ nnuru a ɛrenya nkɔanim a ɛfiri Europa ne Amerika Atifi fam kɔ ​​Asia Kesee Fam Apueeɛ (India, Indonesia, Thailand, Vietnam) ne Afrika (Egypt, South Africa, Kenya, Nigeria).

Supply Chain Shift ne Compliance Nhyɛso wɔ Viscosity Sɔhwɛ so

Wɔ mfeɛ du a atwam no mu no, wiase nyinaa nnuru a wɔde ma no anya nsakraeɛ kɛseɛ wɔ asasesin mu — API ne nnuru a wɔde yɛ nnuru a ɛrenya nkɔanim a ɛfiri Europa ne Amerika Atifi fam kɔ ​​Asia Kesee Fam Apueeɛ (India, Indonesia, Thailand, Vietnam) ne Afrika (Egypt, South Africa, Kenya, Nigeria). Mfaso a ɛwɔ ɛka a wɔbɔ ne mpɔtam hɔ gua ahorow a ɛrenya nkɔso no na ɛde saa su yi ba.

Nanso, nsakrae yi nso de nsɛnnennen a ɛfa mmara a wodi so yiye ho ba. Mmarahyɛ mpanyimfo a wɔwɔ Europa ne U.S. (te sɛ FDA, EMA) hwehwɛ sɛ nnuru a wɔde fi amannɔne ba no du gyinapɛn koro no ara a wɔde yɛ nneɛma a wɔyɛ wɔ ɔman no mu no ho. Eyi kyerɛ sɛ ɛsɛ sɛ nnuruyɛ adwumayɛbea ahorow a ɛwɔ Asia Kesee Fam Apuei ne Afrika hyehyɛ QC nhyehyɛe ahorow a ɛne amanaman ntam gyinapɛn ahorow hyia, a viscosity sɔhwɛ yɛ ade a ɛho nhia.

Wɔ supplier audits mu no, viscosity testing data a wodi so no taa yɛ ade titiriw a wɔde wɔn adwene si so. Auditors check: So wɔayɛ viscometer no ho nhwehwɛmu? So calibration adansedi krataa no yɛ adwuma? So wɔagye ɔkwan a wɔfa so sɔ sɔhwɛ no atom? So wotumi hwehwɛ sɔhwɛ no mu nsɛm no mu? So wɔatete wɔn a wɔyɛ adwuma no? Nsɛmmisa yi ho mmuae a ɛnnɔɔso betumi ama akontaabu adi nkogu, na mpo aka nneɛma a wɔkyerɛw din wɔ Europa ne U.S. gua so.

GMP-Compliant Viscosity Testing System a wɔde besi hɔ: Nnwinnade, Adeyɛ, ne Adwumayɛfo

Sɛ wɔde GMP-compliant viscosity testing system besi hɔ a, ɛhwehwɛ sɛ wɔyɛ nneɛma abiɛsa: nnwinnade, ɔkwan a wɔfa so yɛ adwuma, ne adwumayɛfo.

Nnwinnade: Nea edi kan no, ɛsɛ sɛ wɔyɛ viscometer no calibrated — sɛnea ɛbɛyɛ yiye no, afe biara wɔde calibration nsu a wotumi hwehwɛ mu wɔ ɔman metrology gyinapɛn ahorow mu (te sɛ NIST-traceable silicone oil) di dwuma. FangService DVPlus + series touchscreen viscometer no wɔ calibration nkaebɔ adwuma a ɛkyerɛ bere a ɛsɛ sɛ wɔyɛ calibration no ankasa, na esiw akontaabu mu asiane ahorow a efi calibrations a werɛ afi mu no ano. Nea ɛto so abien, ɛsɛ sɛ mfiri no nya data mudi mu kura nneɛma — a nea ɛka ho ne hokwan ahorow a ɔde di dwuma no sohwɛ, akontaabu akwan, data a wɔde sie, ne nsakrae a wosiw ano. DVPlus+ series no boa 21 CFR Ɔfa 11 mmara sodi, a ɛlɛtrɔnik nsaano nkyerɛwee, akontabuo akwan, ne data a wɔde kɔ amannɔne ka ho.

Adeyɛ: Ɛsɛ sɛ wɔhyehyɛ adwumayɛ ho nhyehyɛe a wɔahyɛ da ayɛ (SOPs), a ɛkyerɛkyerɛ adwumayɛ mu ahwehwɛde ahorow mu pefee ma sɔhwɛ anammɔn biara. Ɛsɛ sɛ SOPs no fa: nhwɛsoɔ ahosiesie ne dwumadie, viscometer dwumadie anammɔn, sɔhwɛ ɔhyeɛ sohwɛ, data a wɔkyerɛw ne amanneɛbɔ, nnwinnadeɛ siesie ne calibration. FangService de mpɔtam hɔ kasa mu SOP nsusuwso ma Asia Kesee Fam Apuei ne Afrika adetɔfo, a ɛboa Borɔfo, Franse, Swahili, Indonesia, Thai, ne Vietnam kasa.

Adwumayɛfoɔ: Ɛsɛ sɛ wɔtete adwumayɛfoɔ na wɔsɔ wɔn hwɛ sɛ wɔfata. Ɛsɛ sɛ ntetee no fa: viscometer adwumayɛ nnyinasosɛm, adwumayɛ nhyehyɛe a ɛyɛ gyinapɛn, mfomso a wɔtaa di ho haw, ne data mudi mu kura ho nimdeɛ. FangService de intanɛt so nteteeɛ adesua ne mpɔtam hɔ nteteeɛ dwumadie ma, na ɛboa adwumayɛfoɔ a wɔwɔ Asia Kesee Fam Apueeɛ ne Afrika nnwuma mu ma wɔhunu adwumayɛ ho nimdeɛ a ɛne mmara hyia ntɛmntɛm.

Viscometer Validation ne Confirmation: Anamɔn Titiriw a Wɔyɛ wɔ Audits mu

Wɔ GMP akontabuo mu no, ‘analytical method validation’ ma viscometer no yɛ anammɔn a ɛho hia. Botae a ɛwɔ validation mu ne sɛ ɛbɛkyerɛ sɛ viscometer no, wɔ sɔhwɛ tebea pɔtee bi mu no, betumi ama nea efi mu ba a ɛyɛ pɛpɛɛpɛ na ɛyɛ pɛpɛɛpɛ bere nyinaa. Validation parameters no bi ne: pɛpɛɛpɛyɛ, pɛpɛɛpɛyɛ, linear range, detection anohyeto, ne robustness.

Wɔ Asia Kesee Fam Apuei ne Afrika nnuruyɛ adwumayɛbea ahorow fam no, viscometer validation hyia nsɛnnennen soronko. Sɛ nhwɛso no, ebia labs a ɛwɔ saa mmeae yi nni mmeae a wɔhwɛ ɔhyew so a ɛyɛ den, na ɛka sɔhwɛ no mu aba pɛpɛɛpɛ. FangService NDJ-1E + dijitaal rotational viscometer no wɔ ɔhyew nhwehwɛmu ne automatic temperature compensation, kyerɛw sample temperature bere a wɔreyɛ sɔhwɛ na ɛteɛ viscosity akenkan so, na ɛtew nkɛntɛnso a ɔhyew mu nsakrae nya wɔ sɔhwɛ aba so.

Bio nso, mpɛn pii no, Asia Kesee Fam Apuei ne Afrika nnuruyɛ adwumayɛbea ahorow nni mfiridwumayɛfo a wɔn ho akokwaw a wɔde gye tom. FangService de ‘validation service package’ a sɔhwɛ nhyehyɛe nhyehyɛe, sɔhwɛ a wɔyɛ, data nhwehwɛmu, ne validation amanneɛbɔ kyerɛw ka ho ma, a ɛboa afɛfo ma wowie viscometer validation. Yɛn validation engineers no wɔ GMP akontabuo mu suahunu a ɛyɛ fɛ na wonim FDA, EMA, ne WHO akontabuo gyinapɛn.

Calibration Service Network wɔ Asia Kesee Fam Apuei ne Afrika

Periodic viscometer calibration yɛ GMP a wɔdi so titiriw ahwehwɛde. Nanso, wɔ Asia Kesee Fam Apuei ne Afrika no, sɛ wobenya calibration services a wotumi hwehwɛ mu a, ɛnyɛ mmerɛw — metrological infrastructure a ɛwɔ aman pii mu no nnyaa nkɔso, na wontumi nkyerɛ sɛ calibration services no bɛba na ɛyɛ ne bere mu de.

FangService ayɛ calibration service network wɔ Asia Kesee Fam Apuei ne Afrika. Yɛwɔ calibration centers wɔ Bangkok, Jakarta, Ho Chi Minh City, Nairobi, Lagos, ne Cairo, a wɔde NIST-traceable standard viscosity fluids ne calibration engineers a wɔyɛ adwumaden ahyɛ mu. Yɛde on-site calibration ne send-in calibration service modes ma, a calibration ntam kwan yɛ asram 6 anaa 12, ne calibration adansedi nkrataa a wotumi di akyi wɔ amanaman ntam gyinapɛn ahorow so.

Wɔ nnwuma a sikasɛm nhyehyɛe anohyeto wom fam no, yɛsan nso de ‘shared calibration services’ ma — nnwuma pii betumi abom atɔ calibration services de akyɛ ɛka. Saa nhwɛso yi yɛ nea nnuruyɛ adwumayɛbea nketewa ne akɛse a ɛwɔ Asia Kesee Fam Apuei ne Afrika ani gye ho titiriw.

Bio nso, FangService DVPlus + series touchscreen viscometer boa ‘self-calibration’ — afiri no ankasa hu spindle rotation resistance na ɛde toto built-in reference values ​​ho, na ɛde self-calibration amanneɛbɔ ba. Bere a ankasa-calibration ntumi nsi abɔnten calibration a wɔahyɛ da ayɛ ananmu no, ɛyɛ ɔkwan a ɛboa ma da biara da quality control, boa nnwumakuw ma wonya ahotoso wɔ nnwinnade adwumayɛ mu wɔ calibrations a wɔahyɛ da ayɛ no ntam.

Afotu a Mfaso: Ahosiesie a Wobɛyɛ ama Supplier Audits

Sɛnea ɛbɛyɛ na wɔasiesie wɔn ho ama wɔn a wɔde nneɛma ma no akontaabu no, ɛsɛ sɛ Asia Kesee Fam Apuei ne Afrika nnuruyɛ adwumayɛbea ahorow di kan siesie wɔn ho:

Nea edi kan no, hwɛ hu sɛ viscometer calibration adansedi nkrataa no yɛ nokware na wotumi hwehwɛ mu wɔ amanaman ntam metrological nhyehyɛe ahorow mu. Sɛ wode FangService mfiri redi dwuma a, ɛnyɛ den sɛ wobɛtumi awie calibration denam yɛn calibration service network no so.

Nea ɛto so abien no, fa sɔhwɛ ho kyerɛwtohɔ nhyehyɛe a edi mũ si hɔ. Ɛsɛ sɛ sɔhwɛ biara kyerɛw: nhwɛsode din, batch nɔma, sɔhwɛ da, sɔhwɛ hyew, viscosity bo, adwumayɛfo nsaano nkyerɛwee. DVPlus + series no touchscreen interface ne data export adwuma no ma saa adeyɛ yi yɛ mmerɛw.

Nea ɛtɔ so mmiɛnsa, siesie SOP ne nteteeɛ ho kyerɛwtohɔ. Ɛsɛ sɛ SOPs no fa akwan a wɔfa so sɔ viscosity sɔhwɛ a wɔtaa de di dwuma nyinaa so, na ɛsɛ sɛ nteteeɛ kyerɛwtohɔ no de nna a wɔde tetee adwumayɛfoɔ no, nteteeɛ mu nsɛm, ne nhwehwɛmu no mu aba ka ho.

Nea ɛto so anan no, yɛ emu akontaabu daa. Mfinimfini akontabuo ne ɔkwan pa a wɔfa so hu nsɛm a ɛbɛtumi aba wɔ mmara sodie ho. Yɛhyɛ nyansa sɛ wɔnyɛ emu akontabuo bosome mmiɛnsa biara, nhwɛ sɛnea viscometer no yɛ adwuma, sɔhwɛ ho kyerɛwtohɔ a edi mũ, ne SOP dwumadie.

FangService de ‘GMP Compliance Package’ ma Asia Kesee Fam Apuei ne Afrika nnuruyɛ adwumakuo, a nea ɛka ho ne: viscometer paw ho nyansahyɛ, calibration services, SOP templates, adwumayɛ ntetee, ne emu akontabuo mmoa. Yɛn botaeɛ ne sɛ yɛbɛboa nnwumakuo ama wɔasisi QC nhyehyɛeɛ a ɛdi amanaman ntam gyinapɛn so wɔ sikasɛm mu anohyetoɔ mu, ahwɛ sɛ wɔbɛfa wɔn a wɔde nneɛma ma no akontabuo mu yie. View the Viscosity Measurement Instruments Collection