Tuyen tap bao cao khoa hoc Hpi nghi Khoa hgc ky thuat Do lufing toan quoc Idn thiir IV Hd Ndi, 11 - 2005
^HOAT DONG THIET LAP CHAT DOI CHIEU SLT DUNG TRONG CONG TAC KIEM TRA, GIAM SAT CHAT LUONG DUOC PHAM
TAI VIET NAM
Nguyin Thi Kim Thanh Vien Kiem nghiem Duac phdm - BdY ti'
I. NANG LUC KY THUAT CUA VIEN KIEM NGHIEM
Vien Kidm nghifim dugc phdm qufic gia (NIDQC) la co quan cao nha't fi Viet Nam trong ITnh vuc kidm tra chd't lugng dugc phdm.
- Con ngufii; 135 CBCNVC, trong dfi cfi: 03 PGS, 6 Tien si, 22 Thac si, 15 DSCKI va 55 DS dai hgc.
- Thifi't hi: HPLC, HPLC gradient Dioarray, HPLC-MS, GC, GC- MS, HPLC phdn tich acid amin, Sdc ky difin di mao quan, AAS (hd'p thu nguyen tfl), May IR, UV-VIS, May kidm tra dfi hoa tan, may kidm tra do tan ra, may do nang sudt quay cue, may do diem chay, cac may chudn dfi tfl dfing. Hang nam cfi kfi' hoach nang cdp va dfii mfii thifi't bi hifin dai, nhfi vdy nang Iflc ky thudt ngay cang dugc ndng cao.
- Nhiem vu:
+ Xac dinh va kidm tra chd't lugng Dugc phdm;
+ Thdm dinh cdc tifiu chudn co sfi;
+ Thie't ldp, san xud't vd cung cdp cac chdt dfi'i chifi'u;
+ Thanh tra va giam sat tinh hinh chd't lugng thudc tai Vifit Nam.
- Ndng luc ky thugt:
+ 10/2003: Dugc VILAS cfing nhdn dat tieu chudn Qufi'c tfi' ISO/IEC 17025 + 3/2004: Dugc Bfi Y tfi' cfing nhdn phfing thfl nghifim dat tifiu chudn GLP.
+ Tfl 2000: hang nam tham gia chuong trinh thfl nghifim thanh thao lifin phong thi nghifim do WHO tfi chfle, cac ke't qua ddu cfi gia tri Z < 2.
+ Tfl 1995: Tham gia chuong trinh thie't ldp chudn khu vuc ASEAN, da chu tri 09 chdt chudn ARS va tham gia ddnh gia hgp tac 23 chdt chudn khac vfii cdc nufic trong khu vflc.
II. TAM QUAN TRONG CUA VIEC XAY QUY CHAT DOI CHIEU
Thufi'c vfii chfle ndng quan trgng dfi'i vfii dfii sfing cua con ngufii doi hoi phai co chdt lugng tfi't, dfi dn dinh cao. Dd dam bao chdt lugng cua thufi'c tfl luc san xudt dfi'n khi luu thflng trfin thi trufing, cdn phai kidm tra tfl nguyfin lieu dfi'n thanh phdm vd mfit trong nhflng yfi'u tfi gfip phdn quan trgng trong cfing tac kiem tra chd't Iflgng dfi la cac chdt dfi'i chifi'u.
Cac chd't dfii chifiu rd't cdn thie't cho hoat dfing cua mgt phong thi nghifim dat tieu chudn GLP, chung dugc sfl dung lam chudn gfi'c dd ddnh gid ham lugng, hoat luc, dfi tinh khifi't va dinh tinh cac nguyfin lieu cung nhu cdc chfi' phdm dugc. Nhu cdu vd cac chat dfi'i chifi'u ngay cang tang nhanh do cfi nhidu phuong phap phdn ti'ch vfii may mfic hifin dai dflgc sfl dung trong nganh Dflgc co yfiu cdu sfl dung chdt dfii chie'u:
- Cdc phuong phdp quang phd: Hfing ngoai (IR), tfl ngoai kha kifi'n (UV-VIS)
- Cac phuong phdp sdc ky: TLC, HPLC, GC.
Phuong phap chudn dfi do lod (dinh lugng khang sinh hg penicilin va cephalosporin).
- Phflong phap dinh Iugng vi sinh
Ngoai cdc phuong phap phdn tich nfiu trfin, vific chudn hod phflong phdp va hifiu chinh cdc dung cu, may mfic phong thi nghifim cung yeu cdu sfl dung chdt dfii chifi'u nhfl:
Hifiu chinh budc sfing va do hdp thu cua may do quang phd tfl ngoai, hifiu chinh may thfl do boa tan, do didm chay, kiem tra su phu hgp cua hfi thfing sdc ky (TLC, GC, H P L Q .
Hifin nay, sfi boat chdt luu thfing trfin thi trufing Vifit Nam khoang 800 chd't, cac phuong phap phdn tich nguyfin lieu va thanh phdm trong cdc Dugc didn My, Anh, Chdu Au, Qufic tfi, Trung Qufic, An Dfi, Thai Lan va Vifit Nam ddu yfiu cdu phai sfl dung chdt dfii chifiu dd xac dinh gia trj ham lugng cung nhu dinh ti'nh.
Theo Phap lfinh do lufing (ky ngay 6/10/1999) va Nghi dinh ciia chinh phu (06/2002/ND-CP):
a) Chudn Qufic gia: la chudn do lufing co dfi chi'nh xac cao nhdt ciia Qufic gia dugc Chinh phu phe duyet dung Iam chudn gfi'c dd xac dinh gia tri cdc chudn con iai cua mfit ITnh vuc do
b) Chudn chinh: la chudn do lufing cfi do chi'nh xac cao nhdt fi mfit dia phuong hoac mfit td chfle de xac dinh gia tri cdc chudn con lai cua ITnh vuc do dfi.
c)Chudn cfing tac: la chudn do lufing dugc dung de kiem dinh hoac hifiu chudn phuong tifin do.
Ngoai cdc vdn dd nfiu trfin, dd phat tridn quy chudn phfing thi nghiem cac don vi kidm nghifim cung nhu san xudt, kinh doanh deu phai lifin ke't vfii chudn gfi'c de thifi't ldp chudn phong thi nghiem cho don vi minh. Viec lien hfi mua chudn nufic ngoai tfin rdt nhidu thfii gian vi phai qua rd't nhidu thu tuc hanh chinh quy dinh vd xud't nhdp khdu, ngodi ra gia cua 1 Ig chudn nufic ngoai cung khfing phai la re (tfl 70 den 156 USD/ Ig), do dfi cdc don vi trong nufic khfi cfi thd dap flng dugc nhu cdu cfing vific khi mua chudn nufic ngoai.
III. NGUYEN TAC CHUNG THIET LAP CHAT DOI C H l t ' u
Theo hflfing ddn cua Td chfle Y tfi' thfi' gifii (WHO) vd thifi't ldp, dfing gfii, phdn phfii vd sfl dung chd't dfii chifi'u ; cac phuong phdp phdn tich hfia ly dugc sfl dung dd danh gia chdt lugng nguyfin lifiu tbifi^t lap chdt dfii chie'u phai phan anh dugc dung tinh cha't cua chdt dfi, cfi dfi chi'nh xac va dfi lap Iai cao, dn dinh va phu hgp vfii muc dich sfl dung.
Di dap flng muc dich su dung trong cac phep thfl hod hgc, vdt Iy hay vi sinh, nguyen lifiu lam chd't dfi'i chifi'u phai la mfit khfii dong nhd't (khfing dugc Idn ta dugc hay chdt bao quan) dugc lua chgn tfl cac Ifi nguyfin lifiu san xudt thuoc co chdt lugng tfit nhdt tfl cdc ngufin cung cdp tin cdy (cac nha san xudt chinh). Mflc dfi tinh khifi't cua nguyfin lifiu phu thufic vao muc dich sfl dung cua chdt dfii chifiii dfi. Mfit chat dfii chieu dugc du kifi^n diing cho phfip thfl dinh lugng phai cfi dfi tinh khifit cao hon mfit chdt dfii chifiu dflgc sfl dung cho muc dich djnh tinh bang phuong phdp do phd hfing ngoai hoac sdc ky lfip mong.
Vific phdn tich chd't lugng nguyfin lifiu, nhdt Id nguyfin lifiu dflng dd thie't ldp chdl dfii chifiu thufing phflc tap, tfin kem, doi hoi nhflng trang thifi't bi hien dai, nhflng hod chdt, chdt chudn ddc bifit, ngufii lam phdn tich phai cfi trinh dfi va kinh nghifim. Tifiu chudn chdt lugng
568
nguyfin lifiu lufin dd cdp dfin cac chi tifiu nhdm chflng minh tinh xac thflc vd hoa hgc va dfi tinh khiet cua nfi.
Cac bflfic trong qua trinh thiet ldp chdt dfii chieu:
a. Xdy dung quy trinh phan tich (protocol): Muc di'ch xay dflng Protocol dd dam bao cdc bflfic tifin hanh phdn tich cflng nhu vific chudn bi thifi't bi, chudn gfi'c, dung mfii hoa chdt gifla cac phfing thi nghifim, giua cac chu ky danh gia khac nhau.
- Dinh tinh: Dfi la cac phuong phap cfi kha nang chflng minh dugc cdc tinh chdt dac tnmg cua hai mdu la dflng.
+ Phuong phap do phfi hong ngoai (IR).
+ Phuong phap Sdc ky: TLC, HPLC, GC, HPLC - MS, GC - MS.
+ Phuong phap do quang phd tfl ngoai (UV).
- Xdc dinh dfi tinh khifit: Dfi tinh khifi't cua nguyfin lieu du kifin thifit ldp chdt dfii chifi'u phu thuflc vao muc dich sfl dung. Dd dap ling cho yeu cdu cua mfit chdt dfii chifiu, phdi xem xfit anh hflfing ciia tap chd't dfin phep do trong khi dinh Iflgng.
+ Cac phuong phdp phdn tich sdc ky: TLC, HPLC, GC.
+ Phflong phap quang phd: UV - VIS
+ Cac phuong phap chudn dfi: Chudn do mfii trufing khan, chudn dfi acid - base, chudn dfi do lod, chudn dfi do thfi.
+ Phuong phdp do gfic quay cue.
+ Phuong phap qufit nhifit vi phdn (DSC): La phuong phap xdc dinh dfi tinh khifit cua nguyen lieu nhanh va nhay, sfl cfi mat cua tap chd't trong nguyfin lifiu cfi thd xac dinh dugc do cfi su khdc nhau vd didm chay.
+ Cdc phuong phap khac: Cac phuong phap khac nhu phdn tich trgng lugng, sdc ky difin di mao quan, phd hdp thu nguyfin tfl la cac phuong phdp cfi gia tri trong vific xdc dinh dfi tinh khifi't.
- Dinh lugng: Ham lugng ciia chdt dfii chifi'u phai dugc xac dinh vfii it nhdt hai phflong phap phdn tich va dflgc xdc dinh bfii it nhat hai phfing thfl nghifim dfic ldp vfii tdng sfi phfip thfl n > 12/ phflong phap phdn tich; RSD < 2,0 %.
b. Dfing gfii :Di dam bao chdt Iflgng cua chdt dfi'i chieu trong sufit thfii gian sfl dung thi vific tifi'n hanh dfing gfii va each bao quan cflng gfip phdn quan trgng.
- Cac Ig dung chd't dfi'i chifi'u phai dam bao trdnh dugc dm, anh sang va khi oxy, thuan tifin trong vific sfl dung.
- Vific dfing gfii cac cha't dfii chifiu cdn dugc tifi'n hdnh trong Glove - Box la noi cfi the kidm soat dugc dfi dm.
- Cac bufie trong qua trinh dfing gfii dugc kiem sodt chat che de tranh nhifim tap cung nhu nhifim chfio, dan sai nhan hodc anh hflfing cua cac yfiu tfi khac cfi thd gdy nfin kfit qua khfing dung cho chd't dfi'i chie'u.
- Mfii Ig chat dfii chifi'u cfi chua mgt lugng nguyfin lifiu du cho mgt Idn kiem tra trong phfip thfl dinh tinh hoac dinh Iflgng.
c. Phat hanh chflng chi phdn tich : - Muc di'ch sfl dung cua chudn.
- Lifin kfi't chudn gfl'c.
- Sfl' lieu phdn tich, cfi thfing bao dfi khfing dam bao do cua phep thir.
d. Kidm tra do dn dinh: Dfi dn dinh ciia cac chd't dfi'i chieu nfin dugc kidm soat bdng cdch tifi'n hanh danh gia lai theo dinh ky. Tdn sfi cua cac Idn thfl phu thufic vao ban chdt cua cha't du kig^n thifi't lap chudn, dfi dm va dieu kifin bao quan.
+ Cha't dd'i chie'u hda hoc ; 2 ndm/ Idn + Chdt ddi chiei vi sinh : I ndnVldn
Chi chu: Cic chit chudn gfic dugc dung d^ so sdnh trong cdc phuong phdp dinh ti'nh va dinh lugng dugc thie't lap vdi su hgp tdc cua nhidu phdng thi nghidm ddc Idp trdn the gidi vd dugc san xudt tai cdc trung tdm sau:
+ Chuin theo Dugc di^n My (USPRS) ; 156 USD/ lo.
+ Chudn theo Dugc diln Chau Au (EPRS) : 75 EUR/ lo.
+ Chudn Qud'c td(ICRS) :70USD/lg.
+ Chudn khu vuc ASEAN (ARS) :40USD/lg.
IV. XlTLtKETQUA
a. Tdp hgp ket qua va loai bd gid tri thd: test Dixon b. Ti'nh gia tri trung binh:
Ex,
:. Ti'nh dd lech chudn:
d. Ti'nh dd Idch chudn mong dd'i:
(«-i)lrU"^/
i?sn==xioo%
X
^ ± / o , 0 5 . ^ e. Tinh khoang tin cdy vdi dd chinh xdc p = 95%:
s
f. Xfl Iy kfi't qua mfit phuang phap phan ti'ch gifla cac phong thi nghifim:
Ti'nh gia tri IZ |: Nfii lfin mflc dfi Ifich gifla tflng gia tri rifing so voi gia tri trung binh.
nithd.
Trong dd: x,: gia tti rieng cua tttng phdng thi nghidm.
X: gia tri trung binh cdng cua cdc phdng thi nghiem sau khi da loai cdc gid
S: Dd lech chudn.
Ndu: | z | < 2 Dat 2< l z | <3 Xemxdt
| z | > 3 Khdngdat g. Ddnh gia ke't qua ciia hai phuong phdp phdn ti'ch (kilm dinh test t):
h. Xtt Iy ke't qua danh gia theo dinh ky:
h. I. Dua theo khoang tin cdy (da dugc ti'nh khi ldm hd so phdn ti'ch) - Ndu ke't qua kidm tra dinh ky ndm trong khoang tin cdy -^ Dat
570
- Neu kfi^t qua kidm tra dinh ky nam ngoai khoang tin cdy ^Tifin hanh so sanh gia tri trung binh cfing cua mdu khi kidm tra dinh ky vfii gia tri trung binh cfing cua mdu ban ddu.
h.2. So sanh gia tri trung binh cfing cua mdu khi kidm tra dinh ky vfii gia tri trung binh cfing cua mdu ban ddu:
* Bufie 1: So sanh 2 phuong sai - Test F (so sanh dfi lap lai cua 2 kfit qua)
* Bufie 2: So sanh hai tri so trung binh - Test t:
+ Nfiut,„<t,,,„(0,95; f):
Hai gia tri trung binh khac nhau khfing co y nghTa thfi'ng kfi Ghi kfit qua va Iflu hfi so.
+ Nfi'u t.„ > t,,,„ (0,95; f^; fg): Thi phai xfit den t,,,, (0,99; f^; fs) - Nfiu t,„ < t„bi. (0,99; f^; fg): Phai tifin hanh khao sat thfim
- Nfi'u t,n > t^bic (0,99; f^; fe): Hai gid tri trung binh khac nhau co y nghTa thfi'ng kfi ->
Ldp bao cao va trinh lanh dao dd ra quyfit dinh.
V. K f T QUA HOAT D O N G
- Quy chdt dfi'i chifi'u do Vifin Kidm nghifim thifi't ldp hifin nay (8/2005) da co 173 boat chdt.
- Sfi lugng chdt dfi'i chifi'u ngay cang tang da tao dieu kifin cho Vifin chu dfing va tich cue trong chuong trinh hgp tac va hfii nhdp vfii cac nufic trong khu vuc vd cfing tac dam bao chd't Iugng thufic.
Cdc don vi sfl dung chudt dfii chifiu dugc thifi't ldp tai Vifin Kiem nghifim bao gfim:
+ Cdc phong kidm nghifim thufic Vifin Kidm nghifim, + 63 Trung tdm Kidm nghifim Dugc phdm - My phdm, + Cac cfing ty va xi nghifip dugc phdm cua nha nufic va tu nhdn,
+ Ngodi ra mfit sfi chd't dfi'i chifi'u con dugc cung cdp cho Vifin Kidm nghifim Thai Lan, Lao, Cdmpuchia; Hfii dfing Dugc didn My va WHO.
* Hieu qud vi' kinh ti'xd hdi:
- Dap flng kip thfii nhu cdu trong nflfic.
- Cdc don vi Kiem nghifim va san xud't trong ca nufic da sfl dung chdt dfii chieu dugc thifit ldp tai VKN dd kidm tra chdt lugng cua cac nguyfin lifiu va thanh phdm dugc san xudt vd luu hanh trfin thi trufing cung nhu sfl dung nhu chd't chudn gfic dd thifi't ldp vd phat tridn quy chudn cua don vi minh ; Cac don vi kidm nghifim va san xudt trong nufic da tiet kifim dugc nhidu thfii gian va tai chi'nh khi khfing phai mua chdt doi chifiu cua nufic ngoai.
- Sfl cfi mat cua cac chd't dfi'i chifi'u gfip phdn hoan thanh nhifim vu dugc giao la dam bao chdt lugng thufic dfi'n tay ngufii bfinh.
- Chflng to dugc ndng luc ky thuat cua Viet Nam so vfii cac nufic trong khu vuc.
