Nối tiếp nội dung phần 1, phần 2 cuốn sách Quản lý chất lượng sản xuất thuốc giới thiệu tới người đọc các kiến thức cơ bản về quản lý phòng thí nghiệm, những yếu tổ ảnh hưởng đến chất lượng thuốc trong sản xuất thuốc và phân tích các điểm trọng yếu cần kiểm soát,... Mời các bạn cùng tham khảo.
Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc NHLTNG KIEN THITC CO BAN VE QUAN LY PHONG THI NGHIEM MUC TIEU HOC TAP • • • Sau hoc xong bdi nay, hoc vien co the: Trinh bay diicic cac yeu cau chung cua phong thi nghiem phu hdp vdi cac chuan miic quoc te Van dung de dinh hudng viec hoan thien va tien t6i xin cong nhan phong thi nghiem tai cd sci NOI DUNG HOC TAP • • • I GlCfl THIEU TAl LIEU VE QUAN LY PHONG THI NGHIEM Phan mof dau Tai lieu neu cac yeu cau chinh yeu lien quan he thong quan ly va cac yeu cau ve nang liic ky thuat ma theo neu mot phong thii nghiem (PTN) cd kha nang dap iing cho nhiing loai phep thii va/hoac hieu chuan nao thi no se dUdc cac to chiic cong nhan thiia nhan nhii la dap iing chuan miic cua viec cdng nhan theo tieu chuan quoc te ISO/IEC17025 ve cac loai phep thii/ hieu chuan tUdng iing He thong quan ly neu d day la mot bo phan cua he thong quan ly chung cua to chiic co phong thii nghiem hoac ciia chinh phong thii nghiem Noi rieng he thong to chiic quan ly neu dUdc xay diing theo nhiing chuan muc doi hoi ciia tieu chuan IS09001 thi no co the diidc cac cd quan cong nhan xem nhii thoa man cac yeu cau ve he thong to chiic nhiing dieu chiia du de minh chiing no co du kha nang ky thuat de cung cap cac ket qua va dti lieu co gia tri ve mat ky thuat Tham chi vao cuol nam 2000, cac tieu chuan IS09001 va ISO 9002 da diidc stia doi, hdp nhat tieu chuan IS 0 1:2000 mang tinh day dti hdn thi du he thong to chtic quan ly ciia phong thti nghiem hieu chuan co dap ting chuan miic nay, neu muon dUdc cong nhan, no cung phai dap ting cac yeu cau ve mat ky thuat Pham vi ap dung Tai lieu diidc ap dung cho moi to chtic hoac bo phan cua mot to chtic 122 Trudng dai hoc Y te cong cong Quan ly chat lupng san xuat thuoc co thac hien cac phep thti nghiem/ hieu chuan Nhting yeu cau khong phu thuoc vao so' liidng nhan vien, khong phu thuoc vao pham vi va linh viic thti nghiem/hieu chuan Khi mot phong thti nghiem hieu chuan khong thac hien mot hoac nhieu hoat dong co neu tai lieu thi ho chi c£n tuyen bo' ho khong ap dung cac yeu cau doi vdi nhting pham vi loai trti Moi phong thti nghiem/ hieu chuan co the sti dung tai lieu nha la mot chi d in de xay diing cho minh mot he thong quan ly hanh chmh, quan ly ky thuat, quan ly chat lu’dng de hoan thien hon moi tac nghiep cua ho, can nh&c cac yeu cau ky thuat de tu so sanh, xac dinh duoc thuc trang cua minh so vdi chuan mile va tti dd de cac giai phap hoan thien thich ting ca ve to chtic quan ly cua he thong chat liidng lan tinh trang trang thiet bi nang liic Mat khac khach hang cua phong thti nghiem, cd quan cd tham quyen va dac biet cd quan cong nhan co the sti dung tai lieu hudng dan nhu la cd sd de xac nhan hoac thtia nhan nang liic cua phong thti nghiem Ldi ich cua viec ap dung Moi phong thti nghiem co the diing tai lieu nhu mot chi dan cho viec xay diing va trien khai cac hoat dong quan ly phu hdp va hieu qua vdi tinh trang thac tai cua minh Hdn the cac phong thti nghiem/hieu chuan ap dung day du cac hudng d in cua tai lieu cd the xay diing va minh chting cho cd quan cdng nhan rfing ho cd he thong quan ly va nang liic ky thuat thoa man cac yeu cau cua tieu chuan ISO/IEC17025 Nhting phong thti nghiem/ hieu chuan neu diidc cd quan cong nhan thtia nhan se cd dUdc uy tin va ldi the tiep thi, ket qua thti nghiem/hieu chuan cua ho se dUdc Uu tien sti dung cho cac hoat dong danh gia, giam dinh hay phan xti mang tinh tai Nen liiu y rin g , cac to chtic cong nhan cua moi nUdc tham gia thoa lidc thtia nhan da phiidng vdi cac to chtic tUdng dudng cua cac quoc gia khac cd sti dung tieu chuan de cdng nhan, thi ket qua thti nghiem va hieu chuan gitia cac phong thi nghiem tuan thu tieu chuan se de dang dUdc dong thtia nhan.Viec tao dieu kien cho sii phat trien hdp tac thudng mai va ky thuat, hai hoa cac tieu chuan, thu tuc va se tao dieu kien cho chinh hoat dong va quan he cua mdi phong thti nghiem iuai II NOI DUNG TAI LIEU De tien cho viec tra ctiu, phan diidi day chting toi se trinh bay mot cach tong quan cac yeu cau ve he thdng to chtic quan ly chat liidng va cac yeu cau ve nang liic cua phong thti nghiem theo tuan tii cac hang muc chinh da dUdc neu IS 017025 Ve cd cau to chtic Phong thti nghiem hoac cd quan chu quan cua PTN phai la mot thiic the 123 Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc co kha nang chiu trach nhiem ve mat phap ly, dap iing duoc tat ca cac yeu cau cua tieu chuan va thoa man cac yeu cau cua khach hang, cua cac cd quan co tham quyen hoac cac cd quan cong nhan Ngoai kha nang thiic hien cac cong viec tai tru sd, PTN cung phai co kha nang thuc hien cac hoat dong tai hien triidng, tai cac dia diem lien ket tam thdi vdi cd sd hay tren cac phudng tien di dong ma ban chat cong viec doi hoi Neu PTN chi la mot bo phan cua mot to chiic co thiic hien cac hoat dong khac vdi cdng viec thu nghiem va/hoac hieu chuan thi ve cd cau to chiic, phai dinh rd trach nhiem cua moi nhan vien chu chot co lien quan hoac co anh hudng t6i cac hoat dong thii nghiem va/hoac hieu chuan cua PTN de nhan biet cac mau thuan co the ve quyen ldi Dieu nh&m dam bao tinh trach nhiem va khach quan hoat dong cua no Cac bo phan co lien quan ve quyen ldi nhii: San xuat kinh doanh, tiep thi hoac tai chinh se khdng gay anh hudng bat ldi den sii tuan thu cua PTN theo cac yeu cau cua tieu chuan Neu mot PTN mong muon dUdc thiia nhan la PTN cua ben thii ba thi ta phai chiing minh rang PTN dd la khach quan, rang nhan vien cua PTN khong chiu mot ap liic nao ve thudng mai, tai chinh hay ap liic khac cd the anh hUdng den quyet dinh co tinh ky thuat Phong thii nghiem hoac hieu chuan cua ben thii ba khdng dUdc tham gia bat cii cac hoat dong nao co the ton hai den tin cay, tinh doc lap ciia cac quyet dinh va tinh trung thiic lien quan den hoat dong thii nghiem hoac hieu chuan ciia no PTN phai xac dinh cd cau to chiic va vi tri ciia no to chiic chii quan va cac moi quan he giiia quan ly chat liidng, hoat dong ky thuat va dich vu ho trd Phai quy dinh trach nhiem, quyen han va moi quan he qua lai ciia tat ca cac nhan vien quan ly, thiic hien hoac kiem tra cong viec co anh hudng den chat ludng ciia phep thii nghiem va/hoac hieu chuan Phong cung phai giam sat mot cach thich hdp trinh ky nang va thao tac ciia cac nhan vien thii nghiem va hieu chuan, bao gom ca cac nhan vien dang tap sii De lam viec nay, chang han can co can bo quan ly ky thuat chiu trach nhiem toan bo cac hoat dong ky thuat NgUdi phai dUdc cung cap cac nguon liic can thiet de dam bao chat liidng cac hoat dong ciia PTN Phong se phai bo nhiem dich danh mot can bo giii vai trd quan ly chat liidng, ngoai cac nhiem vu va cac trach nhiem khac, ngUdi co trach nhiem va quyen han rd rang dam bao cho he thong chat liidng luon du'dc thiic hien va tuan thu, diidc phep lien he triic tiep v6i cap quan ly cao nhat co tham quyen diia cac quyet dinh ve chinh sach va nguon liic ciia PTN Phong phai xem xet viec bo nhiem cac cap thay the ngiidi phu trach quan ly chii chot ho di vang He thong chat lu’dng Nhii da neu he thong chat liidng la cd cau to chiic, thu tuc, qua trinh va nguon liic can thiet de thiic hien cong tac quan ly chat liidng He thong 124 Trudng dai hoc Y te cdng cong Quan ly chat luong san xuat thuoc la mot phan cau he thong quan ly chung cua ban than phong thii nghiem va luan diem xay diing cua he thong chat lifdng phong thii nghiem cung tuan thu nguyen tac: D inh hudng khach hang va thi trUdng Vai tro lanh dao Su tham gia cua moi vien Phudng phap qua trinh Phudng thiic tiep can mang tinh he thong Cai tien lien tuc Quyet dinh diia tren sii kien Phat trien quan he hdp tac PTN phai thiet lap, thiic hien va tri mot he thong chat liidng phu hdp v6i quy md hoat dong cua no Phong phai lap van ban cac chinh sach, he thong, chUdng trinh, thu tuc, hucfng dan pham vi can thiet de dam bao chat lifdng cho ket qua thii nghiem va/hoac hieu chuan Cac chinh sach va muc tieu ve chat lifdng ciia PTN phai dUdc xac dinh so tay chat lifdng va phai dUdc lanh dao cam ket Moi tai lieu sii dung he thong chat lifdng phai dUdc bien, hieu rd, luon san co va dUdc cac nhan vien co trinh thich iing sii dung Kiem soat tai lieu PTN phai thiet lap va tri cac thii tuc kiem soat tat ca cac tai lieu cua he thong chat lifdng (cac tai lieu noi bo hoac co nguon goc tii ben ngoai) nhif: Cac quy dinh, tieu chuan, tai lieu tieu chuan khac, phudng phap thii va/hoac hieu chuan cung nhif cac ban ve, phan mem, qui dinh ky thuat, hu6ng d in va so tay Tat ca cac tai lieu phai difdc bien soan, xem xet, phe chuan ca ve noi dung chuyen mon cung nhu cach trinh bay dinh dang thong nhat trifdc sii dung V iec ban hanh, phan phoi, cap nhat, siia doi, thu hoi, thay the hay loai bo moi tai lieu loi thdi deu phai theo mot thii tuc da dinh Nhiing dieu cung difdc ap dung cho cac tai lieu dUdc liiu giuf he thong may tinh Xem xet cac yeu cau, de nghi va hdp dong Phan de cap viec PTN co lap va tri thu tuc xem xet cac yeu cau, de nghi va hdp dong ciia khach hang qua dd dam bao hieu dung cac yeu cau ciia khach hang, co kha nang va chuan bi day du cac dieu kien de dap iing cac yeu c iu Vi du nang liic va nguon liic, phudng phap thu va/hdac hieu chuan thich hdp difdc liia chon va co kha nang dap iing yeu cau ciia khach hang Yeu cau cung k h in g dinh rin g bat cii sii khac biet nao giiia yeu 125 Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc cau hoac de nghi va hop dong phai duoc giai quyet trudc b it dau cong viec Moi hdp dong phai diidc ca hai ben PTN va khach hang chap nhan Phong thii nghiem phai bao cho khach hang ve moi thay doi neu co cua hdp dong Tham chi neu hdp dong can thay doi sau cdng viec da b it dau thiic hien thi phai lap lai qua trinh xem xet hdp dong nhu trudc dd va moi thay doi phai dUdc thong bao cho tat ca cac nhan vien lien quan Ho?p dong phu ve thvf nghiem va hieu chuan Trudng hdp cd bat cii cong viec nao ngUdi thau phu cua PTN tien hanh, phong thii nghiem cung phai ap dung viec xem xet doi vdi ho va phai bao b in g van ban cho khach hang ve viec dd cung nhu phai dUdc sii dong y cua khach hang ve viec PTN chiu trach nhiem doi vdi khach hang ve cong viec ciia nha thau phu ngoai tru: trudng hdp khach hang hoac cO quan cd tham quyen chi dinh nha thau phu can dUdc sii dung PTN phai cd mot so dang ky tat ca cac nha thau phu sii dung cho cac phep thii va/hoac hieu chuan va phai cd ho sd chiing minh cac nha thau phu phu hdp vdi tieu chuan doi vdi cong viec dUdc yeu c iu Dich vu mua sam va nguon cung cap PTN phai cd chinh sach, thii tuc ve liia chon va sii dung dich vu mua sim dung cu, thiet bi, thuoc thii va cac hoa chat, vat lieu can sii dung co lien quan den hoat dong thii nghiem va hieu chuan PTN phai dam bao r in g cac nha cung iing, cac thuoc thii va vat lieu tieu thu dude mua cd anh hiidng tdi chat liidng ciia cac phep thii va/hoac hieu chuan se khdng diidc sii dung cho den chung diidc kiem tra va hieu chuan hoac phai dUdc xac nhan la da phu hdp vdi quy dinh ky thuat tieu chuan hoac cac yeu cau diidc quy dinh cac phudng phap thii nghiem va/hoac hieu chuan lien quan Cac dich vu va hang cung cap diidc sii dung phai tuan thii theo yeu cau da qui dinh Phai cd va liiu giii ho sd minh chiing ve hoat dong kiem tra sii phu hdp Tai lieu mua s im ndi chung hay cac ddn dat hang cu the cho nhiing hang muc cd anh hudng tdi chat lifdng thu nghiem hieu chuan phai md ta rd, chang han chiing loai, cap, hang, nhan dang chinh xac, qui dinh ky thuat, hudng dan kiem tra, so lieu ky thuat khac bao gom viec chap nhan cac ket qua thii nghiem, chat liidng yeu cau va chuan miic he thong chat lifdng cua cd sd san xuat cung cap cac san pham dd PTN phai danh gia nang liic cac nha cung cap vat tu, dich vu chu yeu cd anh hudng den chat lifdng ciia thii nghiem va hieu chuan va phai tri, cap nhat cac ho sd danh gia, danh sach nha cung cap dUdc phe chuan 126 Trudng dai hoc Y te cdng cong Quan ly chat li/png san xuat thuoc Dich vu doi vdi khach hang PTN phai tao dieu kien cho khach hang hoac dai dien cua khach hang co dieu kien hdp tac de lam rd cac yeu cau cua khach hang va de theo ddi hoat dong cua PTN n h im dam bao dUdc tmh bao mat doi vdi khach hang khac Sii hdp tac co the the hien qua viec: Tao dieu kien cho khach hang hoac dai dien cua khach hang tiep can mot cach hdp ly vdi cac llnh vUc lien quan cua PTN de chiing kien thuc hien cac phep thii va/hoac hieu chuan cho khach hang, chiing kien viec chuan bi, dong goi va giii cac mau thii va/hoac hieu chuan khach hang yeu cau vi muc dich tham tra; Thong bao cho khach hang bat cii sii cham tre nao hoac co thay doi ldn lien quan tdi cong viec thii nghiem va/hoac hieu chuan Quan tam moi thdng tin phan hoi ciia khach hang, ke ca thong tin tich ciic va tieu ciic va sii dung cac thong tin de cai tien he thong chat liidng, cac hoat dong thu nghiem va hieu chuan cung nhii cung cach phuc vu khach hang Khieu nai PTN phai co chinh sach va thii tuc de giai quyet cac khieu nai cua khach hang hoac cac ben khac PTN phai lUu giut ho sd cua tat ca cac khieu nai, cac lan dieu tra cung nhu ket qua ciia cac hanh dong khac phuc doi vdi cac khieu nai Kiem soat cong viec thii nghiem va/ hoac hieu chuan khong phu hdp PTN phai co chinh sach va thii tuc de ap dung co bat cii cong viec thii nghiem va/hoac hieu chuan ciia PTN hoac ket qua ciia cong viec khong phu hdp vdi cac thii tuc ciia PTN hoac cac yeu cau da thoa thuan vo'i khach hang Chinh sach va thu tuc phai dam bao ring: a Xac dinh trach nhiem va quyen han de quan ly cong viec khong phu hdp nha tam ngiing cong viec, tut chol khdng lam bao cao thu nghiem, tam ngu'ng cap chung chi hieu chuan can thiet b Danh gia muc va tinh nghiem ciia cong viec khdng phu hdp c Phai cd hanh dong k h ic phuc dUdc thuc hien lap tiic cung vdi moi quyet dinh ve kha nang chap nhan cdng viec khdng phii hdp d Khi can thiet PTN phai thdng bao cho khach hang va thu hoi lai ket qua cdng viec khdng phu hdp; e Dinh rd du'dc trach nhiem ve quyen han cho phep tiep tuc cdng viec Cac cdng viec khdng phu ho'p hoac cac van de khdng phu hdp phat sinh 127 Trudng dai hoc Y te cdng cong Quan ly chat luong san xuat thuoc he thong chat liidng hoac cac hoat dong thii nghiem va/hoac hieu chuan co the xay tai nhieu ndi khac he thong chat liidng Vf du: Khieu nai cua khach hang, viec kiem soat chat liidng, hieu chuan thiet bi, kiem tra cac vat lieu tieu thu, giam sat nhan vien, tra, bien ban va viec kiem tra giay chiing nhan, viec xem xet ciia lanh dao va cac cuoc danh gia noi bo hoac ben ngoai Khi viec danh gia chi r in g cdng viec khdng phu hdp co the lai xay hoac co nghi ngd ve sii phu hdp so v6i cac chinh sach va cac thii tuc cua PTN thi phong thii nghiem can ap dung thu tuc hanh dong k h ic phuc du6i day 10 Hanh dong khac phuc PTN phai xay diing chmh sach, thii tuc va phai phan cong cac trach nhiem thich hdp de thiic hien hanh dong k h ic phuc (la hanh dong dUdc tien hanh de loai bo cac nguyen nhan gay tinh trang khdng phu hdp von di dang ton tai, dong thdi de ngan chan sii tai d iin tinh trang khong phu hdp do) xac dinh dUdc cong viec khdng phu hdp hoac cac sai khac so v6i chinh sach va thu tuc he thong chat liidng hoac cac hoat dong ky thuat V6i nhiing sii khdng phu hdp ma nguyen nhan ciia no da rd ta co the tien hanh cac hanh dong khac phuc nhung vdi cac trUdng hdp nguyen nhan cua no chua rd hoac cd the co nhieu nguyen nhan thi van de phan tich tim va xac dinh miic quan cua chung de de bien phap khac phuc lai la mot dieu rat can thiet va kho khan Thdng thiidng thu tuc ve hanh dong khac phuc phai dUdc b it dau bang mot cuoc dieu tra de xac dinh cac nguyen nhan chinh ciia van de Do cac nguyen nhan chinh lai khdng rd rang nen viec doi hoi can phan tich can than tat ca cac nguyen nhan tiem an co the xay Cac nguyen nhan tiem an co the bao gom: Viec lay, xii ly, liiu mau, cac yeu cau cua khach hang, qui dinh ky thuat cua m lu , phudng phap va thii tuc, tay nghe va dao tao nhan vien, chiing loai chat liidng vat lieu tieu thu hoac thiet bi va viec hieu chuan thiet bi Phong thu nghiem phai xac dinh hanh dong k h ic phuc va phai liia chon, thiic hien hanh dong kh ic phuc co the thiic hien d§ nhat de loai trii van de va ngan chan no tai dien Vi ly cac hanh dong k h ic phuc phai diidc xem xet cho tiidng xiing v6i miic quan va sii nguy hiem cua van de Sau thiic hien cac hanh dong k h ic phuc neu co nhiing thay doi sinh tii viec dieu tra nghien ciiu ve hanh dong k h ic phuc thi PTN phai lap van ban de thong bao va cho ap dung nhiing thay doi V6i nhiing giai phap k h ic phuc da neu PTN phai kiem soat ket qua de dam bao hanh dong khac phuc da thiic hien la co hieu qua Trong trUdng hdp can thiet hoac phat hien co sii khdng phu hdp hoac sai khac gay nghi ngd ve sii phu hdp ciia PTN thi PTN phai dam bao r in g tai cac linh viic co nghi ngd se dUdc danh gia xem xet bo sung kip thdi 128 Trudng dai hoc Y te cdng cdng Quan ly chat luong san xuS't thudc 11 Hanh dong phong ngvfa Khong chi vdi nhting si1 khong phu hdp da xay ra, phong thu nghiem phai xac dinh nhiing cai tien can thiet cho nhiing sii khdng phu hdp tiem an ca ve mat ky thuat lin he thong chat liidng, nghia la phai xac dinh cac hanh dong phong ngiia de loai bo mot sd" nguyen nhan cd kha nang gay sii khdng phu hdp, xay dting ke hoach hanh dong, thtic hien va kiem soat hanh dong dd; so v6i hanh dong khac phuc Hanh dong phong ngiia la mot qua trinh "cd xu the chu dong" de xac dinh cac cd hoi cai tien hdn la mot phan iing ddi n iy sinh tii viec xac nhan van de da phat sinh hoac khieu nai 12 Kiem soat ho sd Ho sd cd the la d bat cii hinh thiic nao vi du ban in may tinh hoac ban lUu dien tii Ho sd la chiing cd minh chiing cho cac hoat dong cua phong thii nghiem dd PTN phai thiet lap va tri cac thii tuc de ma hoa, tap hdp, danh so, truy cap, lu'u trii, tri va ly cac ho sd chat liidng va ky thuat cho cd the de dang truy tim va dUdc liiu giuc mot mdi triidng thich hdp de ngan chan hu hong hoac xuong cap cung nhu phong ngiia mat mat Thdi gian lUu giii tiing loai ho sd phai dUdc quy dinh cho phu hdp v6i nhu c iu sii dung hoac cac yeu cau phap ly Tat ca cac ho sd phai diidc liiu giii an toan va dam bao tinh bao mat Vdi cac loai ho sd diidc lUu giii may tinh, PTN phai co cac thii tuc de bao ve va lai sd" lieu va ngan ngiia viec tiep can khdng diidc phep hoac tinh trang sUa doi dii lieu Vdi cac loai ho sd lien quan dac tinh ky thuat, nhu tap hdp dii lieu va thdng tin co du'dc thiic hien cac phep thii va/hoac hieu chuan va chi so" lieu thdng so" ciia qua trinh va chat liidng qui dinh cd dat diidc hay khdng Ho sd ky thuat co the bao gom cac bieu mau, hdp dong, phieu lam viec, so ghi chep td rdi kiem tra, sd ghi chep cdng viec, thi kiem soat, bien ban va giay chiing nhan hieu chuan noi bo va ben ngoai, thdng bao ciia khach hang va thdng tin phan hoi v.v PTN phai liiu giii ho so ciia cac quan trie goc, so" lieu da truyen d in va thong tin can thiet de thiet lap mot cuoc danh gia, ho sd hieu chuan ho sd nhan vien va mot ban cua mdi bao cao thii nghiem hoac chiing chi hieu chuan da ban hanh mot thdi gian nhat dinh Ho so' doi vo'i moi phep thu' hoac hieu chuan phai liiu giu day dii cac thong tin de tao dieu kien xac dinh cac yeu td" anh hudng den khdng dam bao neu co the va de tao dieu kien cho cac phep thu va hieu chuan diidc lap lai du6i dieu kien gan vdi dieu kien ban dau nhat Cac ho sd phai bao gom ca viec xac dinh ngudi chiu trach nhiem lay m lu, thtic hien tiing phep thii va/hoac hieu chuan va ngudi kiem tra ket qua Khi cac ho sd co sai loi, phai diidc gach len sai loi do, khong du'oc tay xoa, lam cho kho doc hoac phai xoa bo va phai ghi thong tin dung T9 - O L C L S X T 129 Truong dai hoc Y te cong cong Quan ly chat lupng san xuat thuoc ben canh Tat ca cac thay doi cac ho so phai difdc chinh ngiidi sUa chiia ky xac nhan hoac viet ta t ten Trong triidng hdp ho sd diidc liiu giii may tinh, phai co bien phap tUdng xting de tranh mat mat hoac thay doi so" lieu goc 13 Danh gia noi bo PTN phai dinh ky tuan thu mot ke hoach va thu tuc da xac dinh thiic hien danh gia noi bo cac hoat dong cua PTN nham tham tra xem cac hoat dong cua PTN tiep tuc tuan thu cac yeu cau cua he thong chat lifdng hay khdng ChUdng trinh danh gia noi bo phai chi rd tat ca cac yeu td" cua he thong cha"t lifdng, bao gom cac hoat dong thu nghiem va/hoac hieu chuan Phu trach cha"t lifdng co trach nhiem lap ke" hoach va td chiic danh gia theo ke" hoach va theo yeu c iu cua lanh dao Viec danh gia phai dtidc nhiing ngtidi da qua dao tao va co trinh chuyen mon, co cac nguon liic cho phep, doc lap vdi linh viic hoac pham vi hoat dong diidc danh gia thiic hien Tai cac phong thii nghiem 16n, yeu c lu thuan ldi hdn vi nhiing ngtidi da dtidc dao tao tai cac bo phan khac co the thtic hien cac cuoc danh gia cheo cho va nhti vay co the dam bao tinh khach quan doc lap Tai cac phong thii nghiem nho, viec co the dtidc thtic hien theo cach linh dong hdn, chang han bd" tri cac trtidng nhom, trtidng cac bo phan danh gia lan Dieu quan la nhting ngtidi danh gia phai am hieu ve cac thu tuc, cac hti6ng dan ma bo phan bi danh gia dang ap dung de tti dd phat hien nhting dieu khdng phti hdp, giup ho hoan thien cong viec hdn 14 Xem xet cua lanh dao Xem xet cua lanh dao ve chat lifdng la cuoc hop ban lanh dao to chtic de kiem tra viec tuan thii qui dinh he thong chat liidng HTCL, sti phti hdp cua HTCL da xay dting do"i v6i yeu cau thtic tien, tinh hieu qua cua viec ap dung he thong chat lifdng hien hanh va cac van de lien quan cac yeu cau ve cha"t lu’dng hoat dong kiem tra thti nghiem hieu chuan Sau hay mtidi hai thang mot lan, lanh dao PTN phai dinh ky thtic hien mot cuoc xem xet he thong cha"t ltidng nhti vay Cuoc xem xet phai de cap t6i: 130 - Sti phu hdp ciia chinh sach va cac thu tuc - Cac bao cao ciia ngtidi quan ly va giam sat - Ket qua cua danh gia noi bo gan day - Hanh dong khac phuc va phong ngtia - Cac cuoc danh gia cua cac td chtic ben ngoai - Ket qua so sanh lien phong hoac thii nghiem thao - Cac thay doi ve khoi ltidng, pham vi cong viec Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc - Thong tin phan hoi tu! khach hang - Khieu nai - Cac yeu to' lien quan khac nhu: Cac hoat dong kiem soat chat ltidng, nguon ltic va dao tao nhan vien Phai cd ho sd ghi lai moi phat hien tti cuoc xem xet cua lanh dao va cac hoat dong phat sinh tti cuoc xem xet Lanh dao phai dam bao cho cac hoat dong thtic hien khoang thdi gian thi'ch hdp nhti da thoa thuan III CAC YEU CAU VE NANG Ll/C KY THUAT Yeu cau chung Co nhieu yeu to' xac dinh mtic chinh xac va tin cay cua phep thti va/hoac hieu chuan PTN thtic hien Chang han yeu to' ngtidi; dieu kien tien nghi va mdi trtidng; phtiong phap thti, hieu chuan va hieu ltic cua phuong phap; thiet bi; tinh trang dan xuat chuan ltidng; cac van de lien quan thu tuc lay mau; cac van de quan ly mau thti nghiem va hieu chuan.v.v Mtic ma cac yeu to" ndi tren gop phan gay khdng dam bao chung cho cac ket qua thti nghiem, hieu chuan cd sti khac dang ke gitia cac loai phep thu va cac hinh thtic hieu chuan PTN phai tinh den cac yeu to' xay dting cac phtidng phap va thu tuc thti nghiem va/hoac hieu chuan, cac yeu to' dao tao va trinh cua nhan vien cung nhti yeu to' ltia chon, hieu chuan thiet bi ma PTN dang sti dung Nhan sti Lanh dao PTN phai dam bao de tat ca nhting ngtidi thao tac cac thiet bi cu the nhting ngtidi thtic hien thti nghiem, hieu chuan, danh gia ket qua phai co trinh ky nang thich ting Neu co sti dung nhan vien dang dtidc dao tao thi phai cd su giam sat thich hdp ciia nhting ngu'di da cd kinh nghiem Cac nhan vien thtic hien cac nhiem vu cu the phai la ngtidi co trinh do, cd cd sd ve trinh giao due dao tao, kinh nghiem thich hdp va/hoac cac ky nang co the chting minh dude dude yeu cau Chang han mot so' linh vtic nhti thii nghiem khong pha huy, nhting ngtidi thtic hien cac nhiem vu cu the phai la nhting nguoi co chting nhan hanh nghe PTN phai chiu trach nhiem dap ting cac yeu cau ve chting nhan hanh nghe Cac yeu cau ve chting nhan hanh nghe cd the la qui dinh hoac cd the bao gom cac tieu chuan ve linh vtic ky thuat cu the hoac khach hang yeu cau Nhan vien chiu trach nhiem nhan xet va dien giai bao cao thti nghiem phai co trinh do, dtidc dao tao, co kinh nghiem phu hdp va co kien thtic thich hop ve phep thii dtidc thtic hien Chang han: 131 Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc Nhufng rang buoc cua luat phap Theo luat, mot nhan hieu can phai : - Khac biet vdi nghia chung (nhu mot doanh nghiep san xuat ca phe khong the dua td "cafe" chung chung lam nhan hieu cua minh dddc) - Trung thdc, la khong dddc lam that vong, khong duoc phep Ida gat ngddi tieu dung ve nguon goc, ban chat, phan, chat lddng hoac viec sd dung - Phu hdp vdi trat td cong cong va nhdng phong tuc tap quan tot, nhd cam dung cac td tho thien - Mdi, tuc khong phai co san, khong dddc dung mot cai ten tddng td hoac gan tddng td vdi ten da co dac biet la cac nhan hieu cua cac hang noi tieng Bao ve nhan hieu C) Phap, cac nhan hieu phai dang ky tai Vien quoc gia ve sd hdu cong nghiep (I.N.P.I) roi mdi dddc sd dung Luat phap se bao ve quyen sd hdu co vi pham ve sd dung nhan hieu II NHAN HIEU HANG HOA VA CAC QUY DINH PHAP LY CUA NO Bo luat Dan sd cua nd6c CHXNCN Viet Nam dddc Quoc hoi thong qua 28.10.1995, phan thd sau ve quyen sd hdu tri tue va chuyen giao cong nghe da co cac quy dinh ve nhan hieu hang hoa Dieu 785 da quy dinh: "Nhan hieu hang hoa la nhdng dau hieu dung de phan biet hang hoa, dich vu cung loai cua cd sd san xuat kinh doanh khac Nhan hieu hang hoa co the la td ngd, hinh anh hoac sd ket hop cac veu to du'dc the hien bang mot hoac nhieu mau sac" Dieu 821 quy dinh : - Trong hdp dong chuyen giao quyen sd dung nhan hieu hang hoa, cac ben co the thoa thuan ben du'dc chuyen giao co nghia vu phai bao dam chat lddng san pham hang hoa mang nhan hieu dddc chuyen giao phai tddng dudng vdi chat lu'dng san pham, hang hoa cung loai mang nhan hieu hang hoa cua ben chuyen giao - Ben chuyen giao nhan hieu hang hoa co quyen kiem tra chat lu'dng san pham, hang hoa cua ben ddo'c chuyen giao; yeu cau ben dude chuyen giao phai thuc hien cac bien phap can thiet de bao dam chat lu'dng san pham hang hoa huv bo hop dong va yeu cau bdi thudng thiet hai, neu ben duo'c chuyen giao khong thuc hien hoac thdc hien khong co ket qua yeu cau cua minh 201 Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc Dau hieu dung lam nhan hieu hang hoa dvfofc bao ho Dau hieu dung lam nhan hieu hang hoa dddc cong nhan la co kha nang phan biet theo Dieu 785 Bo luat dan sd neu dap iing day du cac dieu kien sau day: a Dddc tao td mot hoac mot so" yeu to" doc dao, de nhan biet hoac td nhieu yeu to" ket hop mot tong the doc dao, de nhan biet va khong phai la dau hieu quy dinh tai Muc b Khong trung hoac khong tddng td tdi mdc gay nham lan vdi nhan hieu hang hoa cua ngddi khac dang dddc bao ho tai Viet Nam (ke ca cac nhan hieu hang hoa dang dddc bao ho theo cac Dieu d6c quoc te" ma Viet Nam tham gia) c Khong trung hoac khong tdOng td tdi mdc gay nham lan vdi nhan hieu hang hoa neu ddn yeu cau cap van bang bao ho nhan hieu hang hoa da nop cho cd quan co tham quyen vdi du tien sdm hdn (ke ca cac ddn ve nhan hieu hang hoa dddc nop theo cac Dieu ddc quoc te" ma Viet Nam tham gia); d Khong trung hoac khong tddng td tdi mdc gay nham lan vdi nhan hieu hang hoa cua ngddi khac da het hieu ldc hoac bi dinh chi hieu ldc bao ho nhdng thdi gian tm h td het hieu ldc hoac bi dinh chi hieu ldc chda qua nam, trd trddng hdp hieu ldc bi dinh chi vi nhan hieu hang hoa khong dddc sd dung theo quy dinh tai Diem c, Khoan 2, Dieu 28 Nghi dinh nay; e Khong trung hoac khong tddng td tdi mdc gay nham lan vdi nhan hieu hang hoa cua ngddi khac dddc coi la noi tieng (theo dieu bis Cong ddc Paris) hoac vdi nhan hieu hang hoa cua ngddi khac da dddc sd dung va da dddc thda nhan mot cach rong rai f Khong trung hoac khong tddng td tdi m dc gay nham lan vdi ten thudng mai dddc bao ho hoac vdi ten goi xuat xd hang hoa dddc bao ho g Khong trung vdi kieu dang cong nghiep dddc bao ho hoac da dddc nop ddn yeu cau cap van bang bao ho vdi uu tien sdm hdn h Khong trung vdi mot hinh tddng nhan vat da thuoc quven tac gia cua ngddi khac trd trddng hdp dddc ngudi cho phep Dau hieu dung lam nhan hieu hang hoa khong difdc bao ho Cac dau hieu sau day khong du'dc Nha nddc bao ho vdi danh nghia la nhan hieu hang hoa : a Dau hieu khong cd kha nang phan biet nhd cac hinh va hinh hoc ddn gian cac chu so" chd cai, cac chd khong cd kha nang phat am nhu mot 202 Trirdng dai hoc Y te cdng cdng Quan ly chat It/ong san xuat thuoc tit ngd; chut niidc ngoai thuoc cac ngon ngii khong thong dung trii trUdng hdp cac dau hieu da diidc sii dung va da diidc thiia nhan mot cach rong rai b Dau hieu, bieu tiidng quy Udc, hinh ve hoac ten goi thong thiidng cua hang hoa thuoc bat ky ngon ngii nao da diidc sii dung rong rai, thudng xuyen, nhieu ngiidi biet den c Dau hieu chi thdi gian, dia diem, phiidng phap san xuat, chung loai, so" liidng, chat liidng, tinh chat, phan, cong dung, gia tri mang tinh mo ta hang hoa, dich vu va xuat xii cua hang hoa, dich vu d Dau hieu lam hieu sai lech, gay nham lan hoac co tinh chat liia dao ngiidi tieu dung ve xuat xii, tinh nang, cong dung, chat liidng, gia tri cua hang hoa hoac dich vu e Dau hieu giong hoac tiidng tii vdi dau chat liidng, dau kiem tra, dau bao hanh cua Viet Nam, niidc ngoai cung nhii cua cac to chiic quoc te f Dau hieu, ten goi (bao gom ca anh, ten, biet hieu, but danh) hinh ve, bieu tiidng giong hoac tiidng tii tdi miic gay nham lln vdi hinh quoc ky, quoc huy, lanh tu, anh dan toe, danh nhan, dia danh, cac to chiic cua V iet Nam cung nhii cua niidc n goa i neu khdng diidc cac cd quan, ngiidi cd tham quyen tiidng iing cho phep III QUY CHE NHAN THUOC VA NHAN HIEU HANG HOA CUA THUOC Quy che nhan thuoc va my pham anh hiidng triic tiep tdi siic khoe ngUdi (Ban hanh theo Quyet dinh sd" 416/2000/QD-BYT 18 thang nam 2000 cua Bo triidng Bo y te) Thiic hien Quyet dinh sd" 178/1999/QD-TTg 30/8/1999 cua Thu tiidng Chmh phu ban hanh Quy che" ghi nhan hang hoa liiu thdng niidc va hang hoa xuat nhap khau va Thdng tii sd" 34/1999/TT-BTM 15/12/1999 cua Bo thiidng mai ve hiidng dan thiic hien Quyet dinh so" 178/1999/QD-TTg 30/8/1999 cua Thu tiidng Chinh phu ban hanh Quy che ghi nhan hang hoa liiu thdng niidc va hang hoa xuat khau, nhap khau, Bo y te" quy dinh cu the viec ghi nhan thudc va my pham anh hiidng triic tiep tdi siic khoe ngiidi Mot so khai niem • • 1.1 Nhan thuoc Nhan thudc la ban in hinh ve, hinh anh, dau hieu diidc in chim, in noi triic tiep tren bao bi thudng pham hoac diidc dan, g in chac c h in tren bao bi thiidng pham cua thudc de the hien cac thdng tin can thiet va chu yeu ve 203 Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thudc thuoc do, giup ngifdi dung Ida chon va sif dung dung thuoc No difdc dung lam can cd de cac cd quan chdc nang thdc hien kiem tra, giam sat, quan ly 1.2 Bao bi thiiOng pham thuoc La bao bi g&n trdc tiep vao thuoc va dddc ban cung vdi thuoc cho ngddi sif dung, gom bao bi ddng thuoc, bao bi n g o a i: a Bao bi ddng thuoc la bao bi trdc tiep tiep xuc de chda ddng thuoc, tao hinh, khoi cho thuoc, hoac boc kin theo hinh, khoi cua thuoc b Bao bi ngoai cua thuoc la bao bi chda mot hoac mot so' bao bi difng thuoc 1.3 Bao bi thuoc khong co tinh chat thUOngpham La bao bi khdng ban le cdng vdi thuoc, gom nhieu loai dddc dung van chuyen, bao quan thuoc tren cac phddng tien van tai hoac cac kho tang 1.4 Noi dung bdt buoc cua nhan thuoc Bao gom nhdng thdng tin quan nhat ve thuoc phai ghi tren nhan thudc 1.5 Noi dung khong bdt buoc cua nhan thuoc La nhdng thdng tin khac, ngoai noi dung bat buoc phai ghi tren nhan thuoc 1.6 Phan chinh cua nhan thuoc La phan ghi cac noi dung bat buoc cua nhan thuoc de ngddi sd dung nhin thay de dang va rd nhat dieu kien bay hang binh thddng, dddc thiet ke thuoc vao kich thddc thdc te cua bao bi trdc tiep ddng thuoc va khdng dddc the hien d ph&n day cua bao bi 1.7 Phan thong tin them La phan tiep noi vdi phan chinh cua nhan, ghi cac noi dung khdng bat buoc cua nhan thuoc, hoac mot so' noi dung bat buoc trddng hdp phan chinh cua nhan khdng du chd de ghi cac noi dung bat buoc dd 1.8 To hudng ddn sit dung thuoc La td di kem theo bao bi thddng pham cua thuoc, dd ghi nhdng thdng tin can thiet de hddng dan trdc tiep cho ngddi sd dung thuoc an toan, hdp ly Cac yeu cau cd ban cua nhan thuoc Tat ca cac chu viet chd so', hinh ve, hinh anh, dau hieu ky hieu ghi tren nhan thuoc phai rd rang, de doc, dung vdi thdc chat cua thudc, khdng dddc gay sd nham lan vdi thuoc khac 204 Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc Ngon nguf trinh bay nhan thuoc - Nhan thuoc san xuat de ldu thong tron g nddc phai dddc viet bflng chu Viet Nam Tuy theo yeu cau cua tiing loai thuoc co the viet them b&ng chut nddc ngoai nhung kfch thddc cua chd nddc ngoai phai nho hdn (toi da la 2/3 kich thddc chuf Viet Nam) - Nhan thuoc san xuat nddc de xuat khau la nhan thuoc da dddc ldu hanh d Viet Nam, nhien co the viet them b&ng chd cua nddc, vung nhap khau thuoc neu co thoa thuan hdp dong mua ban thuoc hoac theo quy dinh cua nddc, vung nhap khau thuoc - Doi vdi thuoc nddc ngoai dang ky, nhap kh&u de tieu thu d thi trddng Viet Nam thi ngon ngd trinh bay tren nhan thuoc phai la tieng Viet hoac tieng Anh, cd the them tieng nddc khac, nhdng kich thu'dc phai nho hdn Phai cd td hddng dan dung thuoc bang tieng Viet di kem theo bao bi thddng pham thuoc Noi dung nhan thuoc 4.1 Noi dung chung cua nhan thuoc 4.1.1 Noi dung bdt buoc a Ten thuoc Ten thuoc cd the - Do nha san xuat dat - M ang ten chung quoc te (ten INN) - Mang ten khoa hoc Chd viet ten thuoc phai dam net, noi bat va khdng dddc nhd hdn mot nda (1/2) so vdi chd cao nhat cd mat tren nhan thuoc b Ten va dia chi cua cd sd san xuat • Ten cd sd san xuat la ten day du cua cd sd san xuat du'dc ghi cac giay td phap ly lien quan den viec lap cd sd san xuat dd Cd the ghi them ten giao dich nhdng cd kfch thddc nho hdn va khdng dam hon ten day du • Neu thudc dddc san xuat hoan chinh tai mot co' sd san xuat, ten cd sd san xuat la nha san xuat dd • Neu thuoc dude ddng gdi td ban pham cua cac nha san xuat khac phai ghi ten dia chi cd sd ddng gdi va ten dia chi cd sd san xuat ban pham • Nhan thuoc san xuat nhddng quyen cua thuoc nddc ngoai tai Viet Nam hoac cua cac nha san xuat Viet Nam khac, phai ghi ddng chd 205 Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thuoc_ Viet Nam "san xuat nhddng quyen cua: (Ghi ten cd sd nhddng quyen) tai: (Ghi ten cd sd nhan nhddng quyen)" va co kich thddc ldn hdn ten cua cd sd nhddng quyen - Dia chi gom co: So nha (neu co), dudng (thon xom), phudng (xa), quan (huyen, thi xa), (tinh), ten nddc c Thanh phan cau tao cua thuoc: • Ghi cac phan cau tao quyet dinh den tac dung cua thuoc da neu tren nhan thuoc • Ddn vi lu'dng thuoc - Khoi lddng: Dung ddn vi gam (viet tat la g), miligam (mg), microgam (meg), kilogam (viet tat kg) neu co khoi lddng ldn - The tich: Dung ddn vi mililit (ml), hoac lit (1) neu thuoc co the tich ldn - Neu khoi lddng nho hdn lm g, the tich nho hdn 1ml thi viet dudi dang so" thap phan (vi du: 0,25mg; 0,5ml) khong viet ddo'i dang phan so" - Co the dung cac ddn vi hoat ldc khac theo hoat chat dUdc sd dung theo thong le quoc te" d Quy each dong goi (dinh lddng cua hang hoa) va dang bao che": • Quy each dong goi cua thuoc la so" lddng hoac khoi lddng the tich, kich thddc thuc cua thuoc co bao bi thddng pham thuoc • Dang bao che cua thuoc dddc ghi theo dang bao che bao bi ddng thuoc e Chi dinh, each dung, chong chi dinh (neu co): Chi dinh dieu tri ghi tren nhan phai phu hdp vdi cong dung cua thuoc Ve cach dung, phai ghi ro ddo'ng ddng lieu ddng cach chia lieu, thdi gian dung Neu thuoc co chong chi dinh phai ghi ro cac trddng hdp chong chi dinh, cac trddng hdp can phai than Trong phan nay, chi yeu cau ghi nhung thong tin thiet yeu du cho ngddi co the su' dung thuoc hdp ly, an toan 20H f So" clang ley (SDK)- So" lo san xuat (SLSX) - Han dung (HD)- Dieu kien bao quan - Ngay san xuat (NSX)- tieu chuan ap dung • Sd dang ky la ky hieu Bo y te Viet Nam (Cue quan ly dddc Viet Nam) cap cho mot thudc cte chdng nhan thudc dd da duoc dang ky tai Viet Nam » Sd lo san xuat cd sd san xuat quy dinh Trddng hdp cau true cua so Id san xuat khdng the hien duo'c san xuat, cd sd san xuat phai ghi them ngav san xuat len nhan (ngav san xuat: ghi thang nam hoan san xuat lo thudc) Trudng dat hoc Y te cdng cong • Quan ly chat luong san xuat thuoc Han dung: La thdi han ma qua moc thdi han do, thuoc khong difdc phep liiu thong va khong dude sti dung Han dung dUdc ghi bfing so chi thang, nam • Dieu kien bao quan thuoc: La cac yeu to" ve moi trifdng bao quan de khong lam bien doi chat lifdng thuoc Phai ghi ro dieu kien bao quan tren nhan thuoc • Tieu chuin: La tieu chuan chat lifdng ma nha san xuat ap dung cho thuoc (vi du: DDVN, BP, TCCS ) • Cach ghi san xuat, han dung : - Ghi theo ngay, thang, nam difdng lich - So' chi gom hai chti so'; so' chi thang gom chti so'; so' chi nam gom chti so' cua nam (vi du: Ngay san xuat: 01/03/2000; HD: 03/2005) g Cac dau hieu luu y: Thuoc thuoc danh muc thuoc ke ddn, tren nhan phai ghi dong chti "Thuoc ban theo ddn" va phai ghi ky hieu R x d goc trai phia tren phan chinh cua nhan Nhan pham thuoc danh muc thuoc doc: Phai co dong chti "Khong dung qua lieu chi dinh" Nhan pham thuoc danh muc thuoc gay nghien, thuoc hifdng tam than : phai co dong chti "Dung theo chi dan cua thay thuoc" Nhan thuoc pham tra, nho mat: Co dong chti "thuoc tra mat" Nhan thuoc pham nho mui: Co dong chti "thuoc nho mui" Neu thuoc can co lifu y dac biet nh&m dam bao an toan cho ngudi su dung thuoc thi phai ghi ro lifu y (Vi du: Khong dude tiem tinh mach) Neu thuoc co the gay tac hai nghiem cho ngifdi va moi trifdng tien hanh huy thuoc khong dung phudng phap thi phai ghi ro nhung dieu can luu y huy thuoc (Vi du: Khong dude dot) Neu thuoc chi difdc dung cho ngifdi ldn phai in them dong chti "cam dung cho tre em" Neu co chong chi dinh cu the den tuoi nao thi phai ghi cu the (Vi du: Khong dung cho tre em dudi tuoi) Tren nhan cua bao bi thifdng pham ngoai cua thuoc phai in dam net dong chti "De xa tam tay cua tre em" va "Dpc ky htidng dan sti dung trtidc dung" 10 Cach ghi dau hieu lifu y : - Cac chti dau hieu c in lifu y phai dude in dam net, chti in hoa, co kich thifdc nho nhat la 1,5mm, ldn nhat la bang ten thuo'c - Neu mot thuo'c phai ghi nhieu dau hieu can lifu y phai ghi du cac 207 Trudng dai hoc Y te cong cong _ Quan ly chat luong san xuat thudc dau hieu ldu y Cac dau hieu lifu y phai du’dc ghi tren phan chmh cua nhan 4.1.2 Ndi dung khong bdt buoc: Ngoai nhiing noi dung b it buoc phai the hien tren nhan thuoc, theo yeu c lu cua tiing loai thuoc, co the ghi them cac thong tin can thiet khac nhiing khong diidc trai vdi cac quy dinh cua Phap luat va cua Quy che nhan, dong thdi khong diidc che khuat hoac lam hieu sai lech n h i i n g noi dung bat buoc ghi tren nhan thuoc Cac noi dung khong bat buoc co the la: Ma so, ma vach, bieu tUdng, dau hieu dung lam nhan hieu hang hoa, ten va dia chi cua nha nhap khau, nha phan phoi nhiing kich thifdc phai nho hdn ten nha san xuat 4.2 Cac nhan thuoc cu the 4.2.1 Nhan nguyen lieu Nhan nguyen lieu lam thuoc can co nhiing noi dung sau : Ten va dia chi cd sd san xuat; Ten nguyen lieu, tieu chuan cua nguyen lieu; Khoi lu’dng hoac the tich dong goi; Nong hoac ham liidng; So”lo san xuat; san xuat; So" dang ky da diidc cap (neu co); Han dung, dieu kien bao quan Nhan nguyen lieu thuoc doc bang A phai co chuf "Doc A" in dam khung tron d goc tren ben trai phan chinh cua nhan Kich thiidc chii "Doc A" it nhat phai bang kich thiidc ten nguyen lieu Nhan nguyen lieu thuoc doc Bang B phai co chii "Doc B" in dam khung tron d goc tren ben trai phan chinh cua nhan Kich thudc chii "Doc B" it nhat phai bang kich thiidc ten nguyen lieu Nhan nguyen lieu lam thuoc gay nghien phai co chut "Gay nghien" Nhan nguyen lieu lam thuoc hudng tam than phai co chii "Hiidng than" Cac chii "Gay nghien", "Hiidng than" co kich thiidc it nhat phai bang ten nguyen lieu diidc in dam khung tron tai goc tren ben phai phan chinh cua nhan Vdi nhan nguyen lieu thuoc doc, thuoc gay nghien hoac thuoc hiidng tam than cua niidc ngoai neu^ khong dap iing diidc cac quy dinh tren thi triidng hdp nha nhap khau nhap kho phai dan nhan phu in dau hieu "Doc A" , "Doc B" "Gay nghien", "Hiidng than" len nhan 4.2.2 Nhan tren vi thuoc Nhan tren vi thuoc toi thieu phai co cac noi dung sau: 208 Tn/tina dai hoc Y t £ cdng cOngr Quan ly c h i't lifd n g san xu a t thuoc Ten cd sd san xuat Ten thuoc So lo san xuat Han dung So dSng ky Vi thuoc phai dddc chiia bao bi thddng pham ngoai cua thuoc vdi du noi dung quy dinh va phai kem theo td hddng dan sti dung thuoc 4.2.3 Nhan in, ddn tren chai lo, ong tiem phai co cac thong tin toi thieu sau day Ten cd scJ san xuat (co the viet tat hoac dung ten giao dich chinh thiic); Ten thuoc, nong hoac ham lddng; The tich hoac khoi lddng; So lo san xuat, han dung; so" dang ky; Dddng dung: Tiem bap (tb), tiem dd6i da (tdd), tiem tinh m ach (tm) ong thuoc tiem phai dddc chda ddng bao bi thddng pham ngoai cua thuoc vdi du noi dung da quy dinh va phai kem theo td hddng dan sti dung thuoc 4.2.4 Nhan in, ddn tren chai lo, ong thuoc udng; hoac cac bao bi chiia dting thuoc co dien tich nho khong chiia du noi dung bdt buoc thi can ph co cac thong tin toi thieu sau day; Ten cd sd san xuat (co the viet tat hoac dung ten giao dich chinh thdc); Ten thuoc, nong hoac ham lddng; The tich hoac khoi lddng; So lo san xuat, han dung; so" dang ky; Dddng dung; Ghi them dong chd "Khong dddc tiem" dam net (ap dung vdi ong thuoc uong) Cac bao bi chda ddng thuoc tren phai co bao bi thddng pham ngoai cua thuoc vdi du noi dung quy dinh va phai kem theo td hddng dan sti dung thuoc 4.2.5 Nhan cua ban pham thuoc diidc sdn xuat d mot cd sd vd dong goi d cd sd khac Noi dung nhd nhan nguyen lieu (thay ten nguyen lieu bang ten ban pham, in so" dang ky neu cd) va phai ghi them dang bao che 4.2.6 N han thuoc pha che theo ddn: Ten va dia chi cd sd pha che theo ddn 209 Trudng dai hoc Y te cong cong Quan ly chat luong san xuat thudc Ten thuoc Quy cach dong goi, dang bao che Cong thiic pha che Cong dung, cach dung, chong chi dinh (neu co) Ngay pha che Han dung, dieu kien bao quan 4.2.7 Nhan thuoc pha che benh vien dung cho benh nhan noi ngoai tru Ten va dia chi cd sd pha che; Ten thuoc; Quy cach dong goi, dang bao che; Cong thdc cho mot ddn vi dong goi nho nhat; Cong dung, cach dung, chong chi dinh (neu co); Ngay pha che; Han dung, dieu kien bao quan 4.2.8 Nhan thuoc khong mang tinh thitOng pham (dung van chuyen, bao quan) Ten va dia chi cd sd san xuat; So" lddng dong goi; Ten thuoc; So" lo san xuat; so" dang ky; han dung; Ten ngddi dong goi Td hufdng dan sti dung thuoc Cac thuoc phai co td hddng dan sti dung thuoc bang tieng Viet Nam kem theo bao bi thddng pham neu noi dung nhan tren bao bi thddng pham khong day du nhdng noi dung quy dinh Td hddng dan sti dung thuoc phai bao gom nhdng noi dung sau: Ten thuoc Cong thdc cho mot ddn vi dong goi nho nhat hoac quy theo lieu (vi du: vien nen, vien nang); Cong thdc phai ghi tat ca cac hoat chat va ta dddc (sti dung ten chung quoc te), ham lddng hoac nong cua tdng chat cong thdc; Dang bao che cua thuoc; Quy cach dong goi: Ghi ro quy cach dong goi chda bao bi trdc tiep va so" lddng bao bi trdc tiep chda bao bi ngoai (vi du: Hop n x 15 vien nen) 210 Trudng dai hoc Y te cdng cdng Quan ly chat luong san xuat thuoc Ten va dia chi cd sd san xuat, dia chi, so dien thoai Fax, E-mail (neu co) Ldi khuyen cao: - "Doc ky hudng d in sii dung trudc dung Neu c ln them thong tin, xin hoi y kien bac si" •- Nhiing thuoc phai ke ddn, ghi them: "Thuoc chi dung theo sU ke ddn cua thay thuoc" Chi dinh: Ghi r5 cac chi dinh dieu tri cu the cua thuoc Nhiing thong tin can biet trudc sii dung thuoc a Chong chi dinh, than trong: Ghi r5 cac trUdng hdp khong dUdc dung thuoc Ghi ro cach phong ngUa, than doi vdi viec dung thuoc Khuyen cao dac biet dung thuoc phai ghi r5 vdi tUng doi tUdng (vi du: tre em, phu nU co thai), anh hudng doi vdi cong viec (vi du: lai tau xe, van hanh may) b Cac tUdng tac cua thuoc vdi cac thuoc khac va cac loai tudng tac khac (vi du: rUdu, thuoc la, thUc pham), nhQng thU co the anh hUdng den tac dung cua thuoc; Tac dung khong mong muon: Ghi ro cac tac dung khong mong muon cua thuoc Ghi chu "Thong bao cho bac si nhUng tac dung khong mong muon gap phai sii dung thuoc"; 10 Hudng dan sU dung: - Lieu dung: Co the ghi lieu dung theo ludng cd the hay theo lieu diing cu the, loai thuoc Phan ro lieu dung cho ngUdi ldn, tre em, ngUdi gia neu co - Cach dung: Ghi dudng dung, cach chia lieu, so" lan dung, dung nao (trUdc, sau bUa an ) phudng phap dung thuoc de dat hieu qua cao nhat (vi du: uong vdi nhieu nUdc ) - Cac trUdng hdp phai ngUng sU dung thuoc - Cac trUdng hdp phai thong bao cho bac si 11 Han dung, bao quan, tieu chuan ap dung - Canh bao viec dung thuoc qua han - Mot vai dau hieu cam quan nghi ngd thuoc qua han hoac kem pham chat - Dieu kien bao quan thuoc thich hdp - Ghi ro thuoc dat theo tieu chuan nao Ma so, ma vach tren nhan thuoc Cac san pham ndi chung va san pham thuoc ndi rieng deu co ma so", ma 211 Trudng dai hoc Y te cdng cdng Quan ty c h it mong san x u it thudc vach, n§u nha san xuat d in g ky vdi Hiep hoi ma so, ma vach Ma so", ma vach giup cac nha san xuat quan ly dddc san pham cua minh Ma cua cac san ph^m hang hoa thddng gom hai phan: Phan ma vach va p h in ma so - Ma vach bao gid cung dddc bieu thi b in g nhdng soc den tren nen trang va co mdc dam nhat khac Chinh kich thudc to nho va mUc dam nhat cua cac vach bieu thi cac thong tin khac da dddc ma hoa De dich dddc nhdng ma phai co nhdng dung cu thich hop (Scaner) + - - Ma so": Thddng dddc bieu dien b in g mot day 13 chd so" Vdi nhdng hang hoa co kich thddc nho, day so" dddc rut gon hoac chd so Vdi mot day ma so" d iy du 13 chd so" Neu tinh td trai sang phai thi: + Hai so" dau tien: La ma cua nddc san xuat san pham + Nam so" tiep theo: La ma so" cua hang san xuat + Nam so" tiep theo nda: La ma cua hang hoa; bao gom nhdng dac diem tieu dung cua hang hoa do, vl du han dung, gia ca + Con so" cuoi cung dddc goi la so" kiem tra dung de kiem dinh tinh dung d in cua viec doc dd c i c ma vach cua Scaner C ich tinh sd" kiem tra nhd sau: + Cong c ic sd" ddng d hang c h in day ma sd" lai vdi nhau, lay tong nhan vdi + Cong c ic sd" ddng d h in g le day ma sd" lai vdi + Cong cac ket qua cua hai phep tinh tren s it tren dd MA CUA M T SO Nl/OC ALLOCATION OF COUNTRY PREFIX 212 00 - 09 U.S.A & Canada 20 - 29 In-store Numbers 30 - 37 France 380 Bulgaria 383 Slovania 385 Croatia 400-440 Germany Quan ly chat luong san xuat thuoc Trudng dai hoc Y te cdng cdng 45 Japan 460-469 Russian Federation 471 Taiwan 480 Philippine Article Numbering Council 489 Hongkong 49 Japan 50 UK 520 Greece 529 Cyprus 535 Malta 539 Ireland 54 Belgium & Luxembourg 560 Portugal 569 Iceland 57 Denmark 590 Poland 599 Hungary 600-601 South Africa 619 Tunisia 64 Finland 690 China 70 Norway 73 Sweden 740-745 Central America 750 Mexico 759 Venezuela 76 Switzerland 770 Colombia 773 Uruguay 775 Peru 779 Argentina 780 Chile 786 Ecuador 789 Brazil 80-83 Italy 213 Quan ty chat luong san xuat thuoc Truong dai hoc Y te cong cong 84 Spain 850 Cuba 859 Czechoslovak 860 Yugoslavia 869 Turkey 87 Netherlands 880 South Korea 885 ThaiLand 888 Singapore 893 Vietnam 890 India 90-91 Austria 93 Australia 94 New Zealand 955 Malaysia Nhan hieu hang hoa cua thuoc La nhiing dau hieu rieng dung de phan biet thuoc cua cac cd sd san xuat khac Nhan hieu hang hoa cua thuoc dUdc doc quven sau dang ky theo Phap lenh bao ho doc quyen sd hiiu cong nghiep Mac du dUdc th e h ie n b a n g ch ii h a y h in h v e , n h a n h ie u h a n g h o a deu p h a i m a n g n h iin g n et dac trU ng ch o cd sd san x u a t Nhan hieu hang hoa co the la mot bo phan hoac toan bo nhan (cach trinh bay nhan) neu no co tinh phan biet cao 50ft nig MUCOMYST 4t4lfirf3t£\ric tOO v*er nartg c£f>e n s u ifr w »x> mO 214 S '* i x*'* tv.-P rv p ZK&li m {1fciI «.*&■ ii :0'* \ : ft 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