QUAN LY -TRAO DPI NGHIEP VU
DjNH HI/6NG NHilM VU CdNG TAC
KliM TRA VA GIAM SAT CHAT Ll/ONG THU6c NAM 2011
PGS.TS. TRINH VAN Liu
Vien trudng Men Kiim nghiem thudc Trung leomg (25/3/2011)
Nam 2010, He thdng kilm nghiem thude ttong cd nudc da hodn thanh xudt sdc cac nhifm vu ehinh tri dugc giao, gdp phdn quan ttgng vao viec dam bdo ehdt lugng thude va my pham phuc vu cdng tac bao vf, chdm sdc va nang cao sfte khde nhan dan ttong tinh hinh mdi da dugc khdng djnh tai Hdi thao cdng tdc kilm tra, giam sat chdt lugng thudc nam 2010 tai Thdnh phd Thanh Hda ngdy 25 thang 3 nam 2011.
Phat huy nhumg thanh tieh da dat duge ttong nam 2010, phdn dau vugt qua nhihig tdn tai vd thach thuc;
nam 2011, Hf thdng kilm nghifm thudc nha nudc vd Phdng kiem nghifm eua eae doanh nghifp can triin khai cac nhifm vu ttgng tam:
1. Phmmg hudng, nhifm vu chinh
1.1. Tang cudng cdng tac kilm tra, gidm sat chdt lugng thude tten dja ban ca nudc nhdm ddm bao thudc den tay ngudi dung ed ehdt lugng, hifu luc va an toan gdp phdn thue hifn thdng lgi Nghj Quylt sd 46-NQ/TW cua Bd Chinh tri ve cdng tdc bdo vf, cham sdc vd ndng cao sue khoe nhdn dan ttong tinh hinh mdi.
1.2. Tilp tuc cting cd vd kifn toan Hf thdng kilm nghifm theo Thdng tu lien tjch Bg Y te va Bg Ngi vu sd 11/2005 TTLT-BYT-BNV ngdy 12/4/2005. Vifn Kilm nghifm thudc Trung uomg se tham gia y kien vdi ede co quan chuc nang dl triin khai Quylt djnh sd 153/2006/
QD-TTg vd Quylt djnh sd 154/2006/QD-TTg ngdy 30 thdng 6 ndm 2006 cua Thu tudng Chinh phu.
1.3. \^fn kilm nghifm thudc Trung uong lam ddu mdi lap du dn ddu tu mua sdm trang thilt bj cho hai Vifn va ede Trung tdm Kilm nghifm bdng ngudn kinh phi cua Quy Todn eau. \^fn Kilm nghifm thudc Trung uomg vd Vifn Kilm nghifm thude TP. Hd Chi Mmh tilp tuc triin khai ed hifu qud vd dung tiln do Du an da dugc Bg trudng phe duyft. Vifn Kilm nghifm thude Trung uomg ldm ddu mdi kit hgp vdi cac co quan chuc ndng ldp Du dn thdnh lap Trung tdm Kilm nghifm khu vue mien Trung.
T w chf KltM NGHIEM THU6C - S6 L2011; T^p 9.(31)
1.4. Trang bj them va ddi mdi thilt bj phdn tfch kilm nghifm cu da lac hau, trudc het can bd sung cac thiet bj kiem nghifm theo yeu cau cua vifc thue hifn Dugc dien Vift Nam vd tieu chuan co sd cua cdc nha san xuat.
7.5. Tiep tuc duy tri qudn Iy phdng thi nghifm theo tieu chudn ISO/IEC 17025 va GLP d cac co sd da dat ISO/IEC 17025 vd GLP. Tung budc xay dung va cdi tao eae Trung tdm Kiem nghifm Dugc-My-Thue pham de cac Trung tdm nay ttd thanh Trung tam phan tich da nang cua Sd Y tl.
1.6. Tiep tuc trien khai du an Cdng nghf thdng tin vd ftng dung ttong cac mdt quan ly cho toan hf thdng kiem nghifm.
1.7. Tdng cudng hgp tac qudc te, ttanh thu su giup dd cua WHO va hgp tac vdi cac nudc ASEAN vl hda hgp ttong qudn ly chat lugng thudc, my pham, thiet Idp- ddnh gid chat ddi chieu khu vyc va thu nghifm thanh thao - danh gid lien phdng thi nghifm. Hgp tac vdi cdc nudc cd dudng bien gidi chung vdi Vift Nam ttong vifc kiem tta, giam sat chat lugng thudc vd phdng chdng thudc gid. Hgp tdc vdi eae nudc ttong khu vuc Tay Thai Binh duomg vl xay dung qui chi vd tieu chudn hoa duge thao (FHH). Tdng cudng hgp tac nghien cuu va dao tao vdi cae trudng dai hgc nudc ngoai.
1.8. Hodn thdnh tdt cdc chuc nang nhifm vu vd kl hoach dugc giao, ddng thdi md rgng boat dgng chuyen mdn k5^ thuat theo hudng sau:
• Ddi vdi Vifn KNT Trung uomg vd Vifn KNT TP.
Hd Chi Minh: ngoai cac cdng vifc kilm nghifm thudng quy, cdn triin khai nghien cuu danh gid sinh khd dung vd tuomg ducmg sinh hge ctia thudc. Tilp tuc nghien eftu triin khai kilm nghifm xdc dinh chdt lugng cae thude cd ngudn gde sinh hge, enzym vd dugc hfu; tiln hdnh khao sat chat lugng mdt sd thude ddng duge vd dugc lieu. Bdng bifn phap ky thudt tham muu mgt cdeh chinh xde cho Bg Y tl quan ly vl chdt lugng thude. Md
cac ldp dao tao cho cac Trung tam Kilm nghiem vd cac Phdng Kilm nghifm cua cac doanh nghiep vl quan ly phdng thi nghiem theo ISO/IEC 17025 va GLP. Tham gia thu nghiem thanh thao va danh gia lien phdng thi nghiem. Xay dung hudng din danh gia phuong phap phan tich ttong thdm djnh tieu chudn chdt lugng; nghien cuu do dn dinh cua thudc tao dieu kien dl hod hgp ve quan ly chat lugng thudc vdi cac nudc tten the gidi ttong bdi canh Viet Nam da la thanh vien cua WTO.
• Ddi vdi cac Trung tam KN, can tiep tuc ap dung phuomg phap vi sinh vat, phuang phap phan tich dung cu, phuong phap phan tich ngoai Dugc dien de kiem tta chat lugng thudc. Tang cudng cdng tac kiem tta, giam sat chat lugng thudc va tiln hanh lay mau mgt each sang lgc. Md cac ldp dao tao cho cac nha thudc, cac doanh nghifp tten dja ban ve cdng tac dam bao chat lugng ttong khau luu thdng, phan phdi thudc.
• Tang cudng hgp tac gifta co quan kiem nghiem nha nudc vdi cac trudng dai hgc, trung hgc y te ttong vifc dao tao ngudn nhan luc, nghien cuu nham nang cao chat lugng thudc.
1.9. Tilp tuc triin khai thuc hifn Nghj djnh 43/2006/
ND-CP ngay 25/4/2006 cua Chinh Phu vl tu ttang ttai mgt phdn kinh phi ap diing cho cac dom vj su nghiep cd thu. Trudc hit la ddi mdi tu duy, manh dan cai each hanh chinh ldy hieu qua lam thudc do. Md rgng ddi tugng phan tich kilm nghiem, thim dinh tieu chudn, tu thiet lap va danh gia chat ddi chieu, chat chuan phdng thi nghifm ... de tang ngudn thu va tiet kifm chi. Tren CO sd do de nang cao ddi sdng vat chat va tinh than cho canbg.
1.10. Cac CO sd san xuat nang cao hom nfta ttach nhifm dam bao chat lugng toan dien tu khau lua chgn nha cung cap nguyen lieu, ttang thiet bj cd uy tin, kiem nghifm chat lugng nguyen heu, thuc hien GMP, GLP, GSP den kiem nghiem day du chat lugng san phdm, day manh nghien cuu cdng nghe bao che cac dang thudc tten phuomg dien nang cao sinh kha dimg va do dn djnh chat lugng cua san pham.
2. Chi tieu ke hoach cu the
2.1. Kiem nghiem xdc ^nh chat Iteqng thudc vd my pham
2.1.1. Ddi v&i Vien KN thudc Trung uang vd Vien KN thudc TP. Hd chi Minh
• Mdi dom vj phai thuc hien kilm nghiem hoac phan tich hit cae miu gui din theo yeu cdu ciia khach hang va tien hanh ldy miu theo hinh thuc mua mdu
(sau day ggi lax la my mau> meo pnuong muc chon lgc nhung dang san phdm, ede boat chdt dl hi biin ddi chdt lugng dl tiln hanh kilm nghiem nhdm han chi thude kem chdt lugng vd thude gid luu hdnh tren thi trudng.
• Noi ldy mdu: tap trung ldy mdu tu ddu nguIn; cac qudy thudc eua cac benh vien;
• Ddi tugng dl ldy miu: chii y nguyen lieu ban dSu, dugc Ueu, thudc ddng dugc, dang bao chi nhiiu thanh phdn, cac dugc chat va dang bao chi kem dn djnh yl chdt lugng. Phuomg thuc ldy miu vd ddi tugng ldy miu sao cho cd tinh chat diiu tta danh gia thuc ttang vl chat lugng;
• Cac dugc chdt dugc kilm nghifm tang them 10%
va tap trung vao cac dugc chat ed tac dimg dac tri.
2.1.2. Ddi v&i cdc Trung tdm KN
• Tang cudng kilm tta, giam sat chdt lugng thuoc tai cac co sd nhu Tram Y tl xa, qudy thudc xa tnmg tam, ttong do chii y den ban dung cua thuoc, tang cudng kiem tta ngudn gde cua thudc dac biet la thuoc ddng dugc va tap trung lay mau thude theo phuong phap sang lgc;
• Tuy theo bien ehi va ttang thilt bi hien co, cac Trung tam Kiem nghifm tien hanh lay mdu va md rdng mat hang lay mau, ttanh tinh ttang lay mau de chay theo kl hoach, nham phat hien cac thudc het han, thuoc khdng ro ngudn gde, thudc kem chat lugng va thuoc gia.
• Noi ldy mau: d tdt ca cac co sd san xudt, ton trii va luu thdng thudc; chu y lay mau d cac vung nong thdn va mien nui, tuyen y tl co sd, chu ttgng nhiing ttgng diem nguy. co cd thudc gia, thudc luu hanh bat hgp phap.
• Tang cudng ttao ddi thdng tin vl chdt lugng thudc vdi Vien KNT Trung uomg, Vifn KNT TP. HCM va Cue QLD bdng cac hinh thuc nhu bao cao. E-mail, dien thoai...
2.1.3. Ddi v&i cdc ca s& sdn xudt kinh doanh
• Kiem nghiem 100% Id nguyen lifu (kl ca td dugc va cac bao bi cdp 1) trudc khi dua vao san xuat va 100% Id san phdm trudc khi xuat xudng.
• Khi tien hanh nhap khau thudc can thuc hien qui trinh lua chgn nha cung cap ed uy tin va tien hanh xem xet chat lugng 100% Id thudc nhdp khau vd kieni nghiem lai nhumg Id thudc nhdp khdu cd nghi ngd ve chat lugmg.
Tap chi KIEM NGHIEM THUOC - So 1.2011; Tap 9.(31)
• Cdn thuc hifn tdt qudn ly chdt lugng todn difn (TQM) vd thudng xuyen giii miu (nhdt Id cac co sd kinh doanh, xudt nhdp khdu chua cd phdng kilm nghifm) din cac co sd kilm nghifm dat tieu chudn GLP dl xdc dinh ehdt lugng trudc khi dua thudc ra thj trudng. Cdn thdnh lap bd phan an ninh mat hang d cac doanh nghifp dl ttanh lam gia thudc cua minh.
2.2. Cong tdc tieu chuan hoa
2.2.1. Ddi v&i Vien KNT trung uang vd Vien KNT TP.Hd Chi Minh
• Phdi tien hdnh soat xet, tham djnh va gdp y hoan thifn mgt each ehinh xac vd kjp thdi tdt ca cac tieu chuan cua cac doanh nghifp, ke ca thdm djnh tieu chudn thudc nudc ngoai trudc khi cap sd dang ky theo yeu cau cua Bd Y te;
• Tham gia cdng tac soat xet va thdm djnh bdng thuc nghifm cac chuyen luan Dugc dien Viet Nam V khi dugc phan cdng.
2.2.2. Ddi v&i cdc Tnmg tdm KN
• Soat xet, tham djnh mdt each chinh xac va kjp thdi tieu chudn cua cac thudc dung ngoai, thudc ddng duge cho dom vj san xuat d dja phuong.
• Tang cudng hen hf vdi cac co sd, vdi Vifn KNT Trung uomg va Vifn KNT TP. Hd Chi Minh dl tung budc giai quylt khd khan ve tieu chuan.
2.2.3. Ddi v&i cdc ca s& sdn xudt
Day manh ftng dimg ky thuat de nang cao muc chat lugng sdn pham dugc the hien ttong cac tieu chuan CO sd va khdng ttai vdi qui dinh cua Dugc di6n Vift Nam.
Phdi hgp vdi Hgi ddng Dugc diin Vift Nam V de xay dung va tham djnh cac tieu chuan ca sd cua minh dl chuyin thanh chuyen luan cua Dugc diin Vift Nam.
2.3. Thiet Ipp vd danh gid chat chuan
• Vien KNT Trung uomg danh gia, thiet lap cac chdt doi ehilu cua Dugc diin Viet Nam mdi va cac chdt chudn phdng thi nghifm, phdi hgp danh gia chdt ddi ehilu ASEAN, cac chuan cua Dugc diin My theo su phdn cdng. Thudng xuyen djnh ky kilm tta lai cac chdt ddi ehilu cua Dugc diin Vift Nam, chuan phdng thi nghifm dl kip thdi thdng bao cho khach hang khi cd su bien doi vl chdt lugng.
Tap chi KlfiM NGHIf M THU6C - S6 1.2011; Tdp 9.(31)
• Vifn KNT TP. Hd Chi Minh va cac Trung tam KN: mdi co sd cdn xay dung mgt quy chuin lam vifc rieng dl phuc vu cdng tac phan tich kilm nghifm. Cac chat chuan phai ddng dudi dang dom lilu va dugc bao qudn theo diing qui djnh.
• Cac CO sd san xuat kinh doanh: cin xay dung quy chudn rieng ciia dom vi dl chu dgng ttong cdng tac kiem nghiem. Tang cudng thdng tin vdi Vifn KNT Trung uomg vl nhumg nguyen lieu cd chit lugng cao dl cung phdi hgp danh gia nguyen heu su dung lam chuin Dugc dien Viet Nam.
2.4. Ho^t dpng khoa hpc
Cac dom vi cin tilp tuc day manh ung dung tiln bg khoa hgc, cdng nghf ttong phan tich kilm nghiem, ddng thdi phat triin nghien ciiu khoa hgc nhdm nang cao ky nang phan tich, kiem nghiem thudc. Trong nghien eftu khoa hgc can ket hgp chat che md hinh gifta Trudng, Vifn va Doanh nghifp hoac Trudng, Trung tam va Doanh nghifp.
• Ddi vdi Vien KNT Trung uomg va Vifn KNT TP. Hd Chi Minh: Trien khai va nghiem thu cac dl tai cap Bg theo dung ke hoach. Ddng thdi tham gia tuyen chgn cung nhu de xuat cac nhiem vu khoa hgc frong ITnh vuc kiem nghiem cho nhiing nam tiep theo. Tiep tuc triin khai du an cdng nghf thdng tin frong kiem nghifm.
• Cac Trung tam KN cdn thuc hifn nghien cuu trien khai nhftng ky thuat phan tich mdi frong kiem nghifm.
Tang cudng mdi quan hf vdi Sd KH - CN de tham gia de tai cap tinh.
• Doi Vdi cac ca sd san xuat kinh doanh: tang cudng de xuat cac nhifm vu khoa hgc phu hgp vdi chien lugc phat triin Khoa hgc - Cdng nghe giai doan 2010-2015 va Chuang trinh phat trien Hda Dugc cua Chinh Phu.
2.5. Thong tin khoa hgcky thugt
Vilt bai cho Tap chi Kiem nghifm thuoc:
Vifn Kilm nghifm thulc Trung uomg: 28 30 bai.
- Vien KNT TP Hd Chi Minh: 5-10 bai.
- Cac Trung tam KN va cac co sd khac co gang viet bai gfti cho Tap chi Kilm nghiem thudc.
2.6. Ddo tgo cdn bp
• Vifn Kilm nghiem thudc Trung uomg va Vien KNT TP. Hd Chi Minh tang cudng kit hcrp vdi Trudng
Dai hgc Dugc Ha Ndi, dai hgc Y Dugc TP. Hd Chi Minh, Hge Vien Qam y... dl ddo tao tten dai hgc: Thac sT va Tien sT.
Vien KNT Trung uong va Vien KNT TP. Hd Chi Minh tilp tue dao tao chuyen mdn cho tuyen dudi bdng nhiiu hinh thftc: td chuc ldp tap hudn ky thuat ve hieu ehudn thilt hi, thu nghifm thanh thao - danh gia lien phdng, ddo tao kem cap tai Vien hoac dao tao tai cac
CO s d . . .
Tren day la nhumg djnh hudng nhiem vu cdng tac kiem tta, giam sat chat lugng thudc nam 2011, d6 nghj ldnh dao hai Vien, gidm ddc cac Trung tdm Kilm nghiem vd Giam ddc cac Doanh nghifp Dugc triin khai kl hoach edng tae thi dua nam 2011 cua Vifn trudng Vifn Kilm nghiem thudc Trung uomg nham dam bao thudc den tay ngudi diing cd chat lugng, hifu luc va an toan gdp phdn thuc hifn thdng lgi Nghj Quylt sd 46-NQ/TW eua Bg Chinh trj vl cdng tac bao ve, cham sdc va nang cao sue khde nhan dan ttong tinh hinh mdi.
3. De ngui 3.LDinghiBpYti
- D I nghi Bg Y tl td chfte Hdi nghj ddnh gia viec thue Men Nghi djnh 43/2006/ND-CP ngdy 25/4/2006 ttong nganh y tl vd tft dd dl xudt vdi Chinh phu chinh sua eho phu hgp vdi tftng vung miin vd khu vuc frong cd nudc.
- De nghj Bd Y tl ed van ban vdi Bd Tai chinh sua lai Thdng tu 103 vl thu phi va If phi ttong Ki&n nghiem thude eho phu hgp vdi diiu kien hifn tai.
- Bd cd y kien chi dao eae tinh, thdnh phd ttong ca nude tap trung ddu tu xay dung mdt Trung tdm Kiem nghifm cua Sd Y te ed chuc nang kiem nghiem da nSng (Thudc, My pham va Thue phdm).
3.2. Ldnh dgo Sd Yte cdc tinh, thdnh phd
Tiep tuc tang cudng cap kinh phi cho cac Trung tam Kiem nghiem de cd diiu kifn sfta chfta, cai tao hoac xay mdi phdng thi nghifm va mua sam ttang thilt bj, dao tao can bd theo tieu chudn ISO/IEC 17025 va GLP
DANH GIA Tl/ONG Dl/GfNG SINH HOC - THl/C HIEN THEO THONG T l / S 6 08/2010/TT-BYTVACAC VAN o i LIEN QUAN
PHUNG THI VINH
Vipn Kiem nghipm thuoc Trung uomg
Nghien cuu sinh kha dung (BA) va tuomg duong sinh hgc (BE) da dugc thuc hifn d Viet Nam ttong vdi nam ttd lai ddy. Tuy nhien, qui dinh vl vifc nop cac dft lifu nghien cuu khi dang ky luu hanh cac thudc generic viia mdi dugc qui djnh tai Thdng tu so 08/2010/
TT-BYT, ngdy 26/04/2010 vl Hit&ng ddn bdo cdo sd lieu nghien cuu sinh khd dting/tirang dieang sinh hoc trong ddng ky thudc (cd hieu luc tu 26/10/2010).
Trong ndi dung gidi thieu va triin khai Thdng tu sd 22/2009/rT-BYT vl Quy dinh viec ddng ky thudc cho cac doanh nghifp. Cue Qudn ly Dugc da cd nhumg hudng ddn chung vl yeu ciu hd so BA/BE. Tuy nhien, tten thuc tl mdt sd doanh nghifp vln cdn kha lung tiing khi ehudn b j cac ndi dung lien quan tdi vdn dl ndy. Dudi ddy frao ddi mdt sd y kien ve tinh hinh nghien cuu va hd so bdo eao ttong thdi gian qua.
Van ban phap qui
Thdng tu sd 08/2010: qui djnh viec nop cac dO lifu nghien ciiu BA/BE cho cdc dang thudc bit bu$c phai nop kit qua BA/BE khi dang ky luu hanh. Trong do, dien hmh la ede cbl phdm phdng thich keo dai (bao gdm phdng thieh chdm - ER, SR, phdng thich co kiem soat CR...) cd chua bit ky dugc chit ndo; Cdc che phim thdng thudng cd chua dugc chdt thude danh muc
12 chit (phu luc 2, TT 08/2010). Ngoai ra, thong tu eung da qui dinh rd hom cho mdt sd trudng hgp thulc o dang phdi hgp, thude cd nhieu ham lugng hoae thay doi sau khi cip phep luu hdnh [1].
Thdng tu sd 22/2009, mye TV, phdn 2, phu luc 2 la hudng din chung ve nghien cuu tuomg duong sinh hQC theo ASEAN [2]. Tuy nhien, bieu mau bao edo neu frong tai hfu nay la ban thao ndm 2004, ehua duge cap nhat Tap chi KIEM NGHIfM THUOC - So 1.2011; T§p 9.(31)
