B GIO DC V O TO TRNG I HC NGN HNG TP.

HCM KHOA QUN TR KINH DOANH

BI TIU LUN
TI: TM HIU V GMP- NH GI QUN L CHT LNG THEO CHUN GMP TI CNG TY C PHN NAM DC.
Ging vin hng dn: H Thin Thng Minh Nhm sinh vin thc hin: Nguyn L Chnh Phm Th Thy Dng Phm Nht Dng Trn Th M Ngc Phm Th Tho Nguyn Quch Th Thanh Phng Ng Th Thanh Tho L Th Nguyn Tho V Th Thanh Thy Cao Th Thu Thy Nguyn Th Thanh Trang : 030326100036 : 030326100054 : 030326100053 : 030326100166 : 030326100152 : 030326100182 : 030326100222 : 030326100220 : 030326100239 : 030326100237 : 030326100248

Nm hc 2013 - 2014

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GVHD: H Thin Thng Minh

LI M U S vn ng pht trin ca th gii trong nhng nm gn y vi xu th ton cu ha nn kinh t th gii to ra nhng thch thc mi trong kinh doanh. S n ph m c th c thit k ti mt quc gia, sn xut, lp rp ti quc gia khc, th trng l ton cu. Cc nh sn xut, phn phi v khch hng ngy nay c quyn la chn sn phm hng ha c cht lng vi gi c ph hp tt c m i ni trn th gii. Vic xo b cc hng ro thu quan, t do ha thng mi lm cho cc doanh nghip nu mun tn ti pht trin phi nng cao cht lng, h gi thnh. Cuc cnh tranh ton cu , ang v s tr nn ngy cng mnh m vi qui m v phm vi ngy cng ln. S pht trin ca khoa hc v cng ngh cho php cc nh sn xut nhy bn c kh nng p ng ngy cng cao nhu c u khch hng, to ra li th cnh tranh.Tnh hnh trn khin cho cht lng tr thnh yu t cnh tranh, tr thnh yu t quyt nh s tn ti v pht trin ca doanh nghip. Cht lng tr thnh mt ngn ng ph bin. thu ht khch hng, cc doanh nghip, t chc cn a cht lng vo ni dung qun l. S ha nhp ca cht lng vo mi yu t ca t chc t hot ng qun l n tc nghip s l iu ph bin v tt yu i vi bt k mt t chc no mun t n ti v pht trin.Cht lng khng t sinh ra, khng phi l mt kt qu ng u nhin m l kt qu ca s tc ng ca hng lot yu t c lin quan cht ch vi nhau. l kt qu ca mt qu trnh. Mun t c cht lng mong mun cn phi qun l mt cch ng n cc yu t ny. Qun l cht lng ngy nay khng ch c p dng trong ngnh cng nghip, m cn trong cc ngnh d ch v, k c dch v hnh chnh cng, trong mi loi hnh cng ty, t quy m ln n quy m nh, cho d c tham gia vo th trng quc t hay khng. Qun l cht lng m bo cho t chc lm ng nhng vic phi lm v t c mc tiu cht lng. Cng vi s pht trin cng cao ca kinh t, khoa hc-k thut mt mt lm cho mc sng ca con ngi ngy cng nng cao v cc nhu cu ngy cng c tha mn.Mt khc cng lm ny sinh cc vn mi trng, an sinh x h i v sc khe. Chnh v l , vn cht lng ca sn phm dch v ni chung v cc sn phm thuc ni ring ang ngy cng c ch trng. Nht l khi sn ph m thuc lin quan trc tip n sc khe v tnh mng con ngi . Mt cng ty tiu biu trong ngnh dc ph m m chng ti mun cp l Cng ty c phn Nam dc. Ton b cc tiu chun m nh my ca Nam Dc c cng nhn nh: GMP - WHO, ISO 9001:2000, ISO 14000:2004, HACCP v SA 8000 hp thnh b tch hp tiu chun IMS (Intergrated Management System) tin tin ca th gii v cht lng sn phm c lm ra t nh my t c

Qun tr cht lng-GMP

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trnh ny c ton th gii cng nhn. Tnh ti thi im hin nay, cha c doanh nghip dc no Vit Nam (k c khi doanh nghip trong nc v khi c vn u t nc ngoi) t c h tch hp tiu chun tin tin ca th gii. iu ny khng nh tm nhn v s mnh ca Nam Dc l c a nhng sn phm c ng cp th gii v cht lng vt tri n tay ngi dn Vit Nam, gp phn nng cao tm sc khe ton dn tc.Trong phm vi nghin cu ca mnh, nhm s lm r 1 trong nhng tiu chun qun l cht lng ni bt m Nam Dc ang p dng, l GMP.

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GVHD: H Thin Thng Minh

Mc lc
I. THC HNH SN XUT TT GMP .............................................................. 1 1. Khi nim GMP: ............................................................................................. 1 2. Lch s ra i GMP: ........................................................................................ 1 3. Phm vi v i tng ki m sot: ..................................................................... 2 3.1. Phm vi p dng: ....................................................................................... 2 3.2. i tng kim sot: ................................................................................. 2 4. Nguyn tc v nguyn l p dng GMP .......................................................... 2 5. Cc yu cu ni dung ca GMP....................................................................... 4 5.1. Nhn s: .................................................................................................... 4 5.2. Thit k, xy dng, lp t nh, xng v thit b ch bin ....................... 4 5.3. Ki m sot v sinh nh xng, mi trng ................................................. 5 5.4. Ki m sot qu trnh ch bin ..................................................................... 5 5.5. Ki m sot qu trnh bo qun v phn phi sn phm ............................... 5 6. Cc yu cu khi p dng .................................................................................. 6 7. Cc bc p dng GMP .................................................................................. 6 8. Cc quy trnh trong p d ng GMP ................................................................... 6 9. Thun li v kh khn khi p dng GMP ........................................................ 8 9.1. Thun li khi p dng GMP ...................................................................... 8 9.2. Kh khn khi p dng GMP ...................................................................... 9 9.3. ngha vic p dng GMP ..................................................................... 11 10. Thc tin v p dng GMP Vit Nam ..................................................... 13 II. GII THIU V CNG TY NAM DC ..................................................... 13 1. Gii thiu v cng ty ..................................................................................... 13 2. Lch s cng ty .............................................................................................. 14 3. S t chc v ban lnh o ....................................................................... 16 4. Knh phn phi ............................................................................................. 17 5. Chin lc pht trin ca Nam Dc: ........................................................... 18 III. DY CHUYN SN XUT CNG TY T CHUN GMP-WHO: .......... 19 Trang i

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1. Tng quan v dy chuyn sn xut ca cng ty Nam dc: ........................... 19 2. Dy chuyn sn xut t chun GMP-WHO.................................................. 19 2.1. Phn tch cc bc p dng GMP-WHO ca cng ty Nam dc: ............ 19 2.2. Phn tch quy trnh sn xut p dng GMP-WHO ................................... 22 3. nh gi thc trng p dng GMP ti Nam Dc ......................................... 28 4. ngha ca vic p dung GMP ti Nam Dc .............................................. 29 IV. KT LUN.................................................................................................... 29 V. TI LIU THAM KHO ............................................................................... 29

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Qun tr cht lng-GMP I. THC HNH SN XUT TT GMP 1. Khi nim GMP:

GVHD: H Thin Thng Minh

GMP l nhng ch vit tt bng ting Anh ca "Good Manufacturing Practice"Thc hnh sn xut tt; bao gm nhng nguyn tc chung, nhng quy nh, hng dn cc ni dung c bn v iu kin sn xut; p dng cho cc c s sn xut, gia cng, ng gi thc phm, dc phm, thit b y t, m phm, t c nhng tiu chun v an ton v sinh cung cp cho ngi tiu dng loi b nhng nguy c nhim cho v ln ln. GMP quan tm n cc yu t quan trng: con ngi, nguyn vt liu, my mc thit b, thao tc, mi trng tt c cc khu vc ca qu trnh sn xut, k c vn gii quyt khiu ni ca khch hng v thu hi sn phm sai li. Nhng yu cu ca GMP c tnh m rng v tng qut, cho php mi nh s n xut c th t quyt nh v s quy nh, tiu chun, th tc, hng dn cng vic sao cho p ng c cc yu cu cn thit, ph hp vi loi hnh, lnh vc sn xut v iu kin c s vt cht ca doanh nghip. Chnh v vy s cc quyt nh, th tc ca h thng GMP ca mi doanh nghip s khc nhau. Hin nay c rt nhiu tiu chun GMP nh GMP current, Canadian GMP, Japanese GMP, European GMP, GMP hip hi cc nc ng Nam (Asean GMP), WHO GMP... 2. Lch s ra i GMP: Nm 1933, Lut Thc phm Dc phm v M phm ca M a ra yu cu thc hin GMP trong qu trnh sn xut cc sn phm ny. Nm 1938, Lut Thc phm Dc phm v M phm ca M ti kho n 510(B) yu cu thc hin cGMP- current Good Manufacturing Practice (thc hnh sn xut tt hin hnh), ngha l cng ngh, quy trnh sn xut, thit b s n xut v cc tiu chun ca sn phm ti cc doanh nghip c thc hin GMP ph i ph hp vi cc tiu chun cng nghip, cc pht minh mi v cng ngh, khoa hc ngay ti thi i m p dng. cGMP nhm nhc nh cc nh sn xut cn ph i dng cc thit b, cng ngh v cc thng tin khoa hc ph hp thi im. GMP-WHO c ban hnh t nhng nm 1960, c cc nh qun l dc ph m v ngnh cng nghip dc ti hng trm quc gia trn th gii, ch yu cc nc ang pht trin p dng. Lut GMP ca EU (GMP-EU) ban hnh nhng quy nh tng t nh GMP-WHO v phin bn ca Lut Thc phm Dc ph m v M phm ti M.

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Qun tr cht lng-GMP

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Nm 1996, cc nc thuc khu vc ASEAN ban hnh b tiu chun chung GMP - ASEAN cho sn xut dc phm v y t, y ban ISO ban hnh tiu chun ISO 15378:2006 - Vt liu ng gi s cp i vi cc sn phm thuc - Nhng yu cu chi tit cho vic ng dng ISO 9001:2000 v Quy phm thc hnh Sn xut tt (GMP). Hin nay, mt s ngnh khc cng p dng cc yu cu ca GMP. Trong nng nghip l GAP Good Agriculture Practice Thc hnh nng nghip tt. Trong cng nghip lm sch l tiu GHP Good Hygien Practice hoc GPP Good Pharmacy Practice Thc hnh nh thuc tt. 3. Phm vi v i tng kim sot: 3.1. Phm vi p dng: GMP c p dng trong cc lnh vc sn xut, ch bin cc sn phm yu cu iu kin v sinh cao nh: Thc phm Dc phm M phm Thit b y t 3.2. i tng kim sot: Nhn s, nh xng, thit b, v sinh sn xut, v sinh mi trng, v sinh c nhn. Qu trnh sn xut: thao tc ca cng nhn, thc hin cc yu cu v nguyn vt liu, v tiu chun sn phm, cng thc pha ch, v iu kin vt cht ca s n xut, nh gi vic cung ng ca nh cung cp nguyn vt liu, cht lng sn ph m: th nghi m mu. Ki m tra: nguyn liu, bn thnh ph m, sn ph m, thao tc ca cng nhn, nh gi nh cung ng, v sinh, X l sn phm khng ph hp, gii quyt khiu ni ca khch hng. Ti liu h s thc hin 4. Nguyn tc v nguyn l p dng GMP Nguyn tc: Tun th 8 nguyn tc ca Qun l cht lng: - Nguyn tc 1: nh hng vo khch hng Cc t chc tn ti ph thuc vo khch hng c a mnh, do h cn ph i hiu cc nhu cu hin ti v tim tng ca khch hng, p ng cc yu cu v phn u vt s mong i ca khch hng. - Nguyn tc 2: Vai tr ca Lnh o

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Qun tr cht lng-GMP

GVHD: H Thin Thng Minh

Lnh o cc t chc, doanh nghip cn phi xc nh mc ch v phng hng thng nht cho t chc ca mnh. H cn phi to v duy tr mi trng n i b m mi ngi tham gia tch cc vo vic t c cc mc tiu ca t chc. - Nguyn tc 3: S tham gia ca mi ngi Con ngi mi v tr, l ti sn qu nht ca mi t chc. Thu ht c s tham gia tch c c ca mi ngi cho php khai thc kh nng ca h trong vic mang li li ch cho t chc. - Nguyn tc 4: Tip cn theo qu trnh Kt qu mong mun s t c mt cch hiu qu hn khi cc ngun lc v cc hot ng lin quan c qun l nh mt qu trnh. - Nguyn tc 5: Phng php h thng Vic xc nh, nm vng v qun l mt h thng bao gm nhiu qu trnh lin quan ln nhau nhm t ti mc tiu gip nng cao hiu qu v hiu lc ca t chc - Nguyn tc 6: Ci tin lin tc Ci tin lin tc phi c coi l mt mc tiu thng trc ca t chc - Nguyn tc 7: Quyt dnh da trn s kin Quyt nh ch c hiu lc khi da trn kt qu phn tch thng tin v d liu - Nguyn tc 8: Hp tc cng c li vi nh cung ng T chc v cc nh cung ng ph thuc ln nhau, mi quan h hai bn cng c li to iu kin cho vic nng cao kh nng ca c hai bn trong vic to gi tr 10 nguyn l c bn trong GMP: Son tho cc quy trnh thao tc chun: b phn QA( Quality Assurance) chuyn trch son tho cc SSOP( standard operating procedure) Thc hin cc quy trnh thao tc chun: Ton th nhn vin p dng nghim tc cc quy nh trong quy trnh c chnh thc ban hnh. Thnh lp h thng ti liu v h s: Tiu chun c s cho nguyn liu, thnh phm. Phng php kim tra, h thng quy trnh, h s l, h s kim nghim, th kho, s kho, s k ton,. Thm nh quy trnh qua thc t: Quy trnh c sa i, ci tin sao cho ph hp vi iu kin thc t v p dng c cc tin b trong lnh vc khoa hc v qun l.

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Qun tr cht lng-GMP

GVHD: H Thin Thng Minh

S dng hp l phng tin v thit b: My mc s dng ng chc nng Bo tr tt phng tin v thit b: Lch bo tr v quy trnh bo tr cho tng my Nhn vin c o to thng xuyn v cp nht: C chng trnh o to hng nm Gi gn sch s v ngn np: Quy trnh v sinh my mc, nh xng Lun cnh gic cao v cht lng: Mi nghi vn v cht lng u c kim tra xc minh, theo di nh gi nh cung cp. Kim tra s thc thi mt cch nghim ngt: k xc nhn cng vic thc hin (Pha ch, bo tr, s ghi chp kt qu phn tch, kim k kho,.) Trong thi gian hiu lc ca chng ch GMP, 6 thng 1 ln Quacert s tin hnh kim tra nh my xem xt vic duy tr chng ch cho doanh nghip. Ngoi vic kim tra ca Quacert, nh my tin hnh vic nh gi ni b v bo co kt qu cho Quacert.(QUACERT l T chc chng nhn ca Vit Nam trc thuc Tng cc Tiu chun o lng Cht lng) 5. Cc yu cu ni dung ca GMP 5.1. Nhn s: Xy dng chun mc cc v tr lm vic tuyn dng ph hp v trnh , nng lc, xy dng quy nh v kim tra sc khe (th lc, tr lc v bnh tt) ca tt c mi ngi, c bit vi nhng cng nhn sn xut trc tip.Thng xuyn gio dc thc t gic chp hnh quy nh v v sinh c nhn, v sinh nh xng, v sinh cng cng cho mi ngi c bit l cng nhn tip xc vi sn phm, nguyn liu v b mt tip xc vi sn phm.C ch thng pht v v sinh v cht lng i vi mi ca, t, nhm sn xut v c nhn.o to v k thut v nhi m v qun l v sinh cho cn b qun l.C cn b chuyn trch kim tra, gim st vic thc hin quy ch v sinh mi cng on trong qu trnh x l 5.2. Thit k, xy dng, lp t nh, xng v thit b ch bin Phi c quy nh v v tr t nh my, thit k, loi nguyn vt liu xy dng nh xng, thit b ph hp. Khi thit k hoc s dng nhng nh xng c, phi ch n cc yu cu v v tr, din tch, vt liu xy dng, thit k m bo khng gy nhi m bn vo sn phm. Cn m bo yu cu i vi phng tin v sinh, phng tin chiu sng, phng tin thng gi, h thng my mc, thit b, dng c dng cho sn xut, h thng thit b m bo an ton.

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Qun tr cht lng-GMP 5.3. Ki m sot v sinh nh xng, mi trng

GVHD: H Thin Thng Minh

Xy dng cc quy nh v x l nc dng sn xut, x l nc thi, x l sn phm ph v rc thi, bo qun 5 ho cht gy nguy hi m, kim sot sinh vt gy hi v v sinh c nhn, v sinh mi trng v nh xng. 5.4. Ki m sot qu trnh ch bin Cn xy dng cc quy nh v phng php ch bin, th tc, hng d n cng vic c th v cc tiu chun v nguyn liu, sn phm, cng thc pha ch v cc bin php kim tra, gim st.Theo cc yu cu ny, t chc phi m bo tt c cc hot ng t khu chun b nguyn liu cho n ton b qu trnh ch bin, k c bao gi, bo qun phi thc hin theo nguyn tc v sinh c bn, ng thi c cc bin php ki m sot cht lng thch hp sao cho cc im kim sot quan trng c xc nh v c kim sot trong sut qu trong qu trnh ch bin 5.5. Ki m sot qu trnh bo qun v phn phi sn phm Bao gm cc yu cu v kim sot cc iu kin, phng tin bo qun, phn phi. Vic vn chuyn v bo qun thnh ph m phi m bo trnh nhim b n sn ph m bi cc tc nhn vt l, ha hc, vi sinh.v khng lm phn hy sn ph m. Tm li, GMP cp n tt c mi yu t v c s vt cht ti thiu nht cn phi c m bo cht lng, v sinh trong ch bin thc phm, dc phm, m ph m. Xy dng v p dng thnh cng GMP s m bo cho doanh nghip chc chn c sn phm t cht lng, an ton theo mc tiu ca doanh nghip. Cng vi GMP, cn mt qui nh khc na la Th tc tc nghip v sinh chun (SSOP- Saniardation Stand Operating Procedure). M t khi SSOP c thc hin tt s gip cho vic thit lp h thng qun l GMP c d dng hn. SSOP cp n cc vn v v sinh lin quan n an ton thc ph m, dc ph m v v sinh mi trng nh: -An ton ngun nc v h thng sn xut nc -Cc b mt tip xc trc tip sn phm -B tr dy chuyn sn xut ngn nga s nhi m cho -Kh trng tay v v sinh c nhn -Bo qun sn phm, bao b -Bo qun v s dng ha cht c tnh cht c hi -Kim sot v tiu dit sinh vt gy hi

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Qun tr cht lng-GMP -Kim sot tnh trng sc khe cng nhn vin 6. Cc yu cu khi p dng

GVHD: H Thin Thng Minh

Cn c s cam kt thc hin ca Lnh o cao nht v hng ng cn b ch cht ca doanh nghip, c s phn cng trch nhim c th, r rng c th huy ng ngun lc ca doanh nghip v huy ng s tham gia tch c c ca cc b phn c lin quan. T chc tt cng tc o to, trong : + o to kin thc c bn v tiu chun GMP (nhp mn) cho tt c m i thnh vin ca doanh nghip hiu r vai tr v tm quan trng ca h thng v t gic thc hin cc quy nh. + o to kin thc chuyn su cho cc cn b ch cht theo tng giai on: k nng xy dng v trin khai p dng h thng ti liu, k nng nh gi ni b v k nng gim st, thm nh GMP. Ban Lnh o cn nh k xem xt, nh gi tnh hiu qu v s ph hp ca qu trnh xy dng v p dng GMP, c s ci tin ph hp. Xy dng mt h thng c kh nng thu hi bt c t sn ph m no c v n t cc ca hng hay kho d tr v x l cc sn phm ny 7. Cc bc p dng GMP Bc 1: Tp hp cc ti liu cn thit Bc 2: Lp k hoch, phn cng c nhn ph trch v xc nh ph m vi p dng GMP a. Phm vi p dng. b. Phn cng c nhn ph trch. Bc 3: Thit lp cc th tc, quy nh, tiu chun cho tng cng on v hun luyn cn b cng nhn vin. a. Thit lp cc th tc, quy nh, tiu chun cho tng cng on b. Hun luyn cn b cng nhn vin. Bc 4: Thc hin v theo di. Bc 5: Gim st vic thc hin: nh gi hiu qu, ci tin. 8. Cc quy trnh trong p dng GMP 1. Xc nh mc ch ca vic p dng GMP 2. Xc nh cc yu cu lut nh v quy chun sn ph m Trang 6

Qun tr cht lng-GMP

GVHD: H Thin Thng Minh

3. Xc nh chnh sch cht lng v mc tiu cht lng 4. Kho st, xc nh cc khc bit gia h thng hin hu v cc yu cu ca lut nh v GMP 5. Thit lp h thng GMP, bao gm vic bo m c s h tng v cc quy trnh vn hnh chun (SOPs, Standard Operating Procedures) 6. Thm tra, xc nhn gi tr s dng ca h thng 7. Tin hnh cc hnh ng khc phc v ci tin Quy trnh gi h s chng nhn v sinh an ton thc phm Bc 1: C s gi h s v Cc An ton v sinh thc phm. Cch thc thc hin: qua ng bu in hoc gi trc tip ti Cc An ton V sinh Thc phm. Bc 2: Cc An ton v sinh thc ph m nhn h s, tr giy bin nhn cho doanh nghip. Bc 3: C quan tip nhn kim tra h s. Nu h s cha hp l th c cng vn yu cu b sung v hon thin h s theo quy nhv phi ghi trn giy bin nhn ngy nhn h s b sung. Bc 4: Sau khi nhn h s hp l, c quan thm nh trong vng 15 ngy lm vic phi thm nh h s v thm nh, kim tra c s. Kt qu thm nh phi ghi r vo bin bn l t hoc Khng t. Trng hp Khng t ph i ghi r l do. Trng hp kt qu thm nh khng t, trong bin bn thm nh phi ghi r thi hn thm nh li (ti a l 03 thng). C s c trch nhi m khc phc yu cu ca on thm nh, nu kt qu thm nh vn khng t th on thm nh lp bin bn v xut vi cc c quan nh nc c thm quyn nh ch hot ng ca c s. Bc 5: Tr kt qu cho c s Thnh phn h s chng nhn v sinh an ton thc phm bao gm: 1. n ngh cp Giy chng nhn (theo mu) 2. Bn sao cng chng Giy chng nhn ng k kinh doanh (nu c) 3. Bn thuyt minh v c s vt cht, trang thit b, dng c bo m i u kin v sinh an ton thc phm, bao g m: a. Bn v s mt bng c s sn xut, kinh doanh v cc khu vc xung quanh. b. Bn m t quy trnh ch bin (quy trnh cng ngh) cho nhm sn ph m hoc mi sn phm c th.

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Qun tr cht lng-GMP

GVHD: H Thin Thng Minh

4. Bn cam kt bo m v sinh, an ton thc phm i vi nguyn liu thc ph m v sn ph m thc phm do c s sn xut, kinh doanh (theo mu). 5. Bn sao cng chng Giy chng nhn iu kin sc kho ca ch c s v ca ngi trc tip sn xut, kinh doanh thc phm. 6. Bn sao cng chng Giy chng nhn c tp hun kin thc v v sinh an ton thc ph m ca ch c s v ca ngi trc tip sn xut, kinh doanh thc phm. L ph ca vic cp giy chng nhn v sinh an ton thc phm L ph cp giy chng nhn c s iu kin v sinh an ton thc phm : 50.000 /1 ln cp Thm nh iu kin v sinh an ton thc phm - 200.000 i vi c s sn xut kinh doanh c sn lng nh hn 20 tn/nm - 300.000 i vi c s sn xut kinh doanh sn lng t 20 tn n nh hn 100 tn/1nm - 400.000 i vi c s sn xut kinh doanh t sn lng t 100 tn n nh hn 500 tn/ 1 nm - 500.000 i vi c s sn xut kinh doanh sn lng t 1000 tn/1 nm tr ln. c tng ln 20 tn/nm cng thm 100.000 9. Thun li v kh khn khi p dng GMP 9.1. Thun li khi p dng GMP Vit Nam, cc doanh nghip tin hnh GMP c s hng ng, hng dn, gip t pha nh nc, B y t, chnh quyn tnh, a phngth hin vic: - Nh nc bo v quyn li cho nhng doanh nghip p dng GMP, trnh hng gi, hng nhi, hng km cht lng ng thi gip qung co thng hi u trn th trng trong nc v quc t. - B Y t ban hnh cc vn bn hng dn c th v da vo thc t hot ng ca doanh nghip nh cc vn bn v tiu chun GMP ASEAN; GMP WHO; GLP; GSP iu chnh l trnh p dng cho ph hp. ng thi thnh lp ban GMP c nng lc t vn, o to nhn lc p ng yu cu ca cc doanh nghip c k hoch u t pht trin theo GMP, thm nh v cp chng ch GMP Trang 8

Qun tr cht lng-GMP

GVHD: H Thin Thng Minh

- Chnh quyn tnh a phng gip cc doanh nghip v mt nguyn liu, mt bng, thm ch cho doanh nghip vay vn pht trin sn xut Ngoi ra, cc doanh nghip p dng GMP sau th c nhiu c hi hc hi v rt kinh nghi m t cc doanh nghip i trc. iu ny khng ch gi m thiu khu tha, khu sai tit kim chi ph m cn gip doanh nghip y nhanh tin p dng. 9.2. Kh khn khi p dng GMP Kh khn trong ni b cc doanh nghip - C s h tng thit b: Vic p dng mt h thng qun l v sinh an ton thc phm ng ngha vi chi ph trong vic nng cp cc thit b, ngun nhn lc. Chi ph cho c s h tng v trang thit b thng thng l ro cn ln nht cho cc doanh nghip thc phm va v nh. GMP c quy nh v mc vn ti thiu ph i c l 17 t ng xy dng nh my, xng sn xut, o to i ng cn b lnh ngh v 10 t ng na hot ng v din tch t ti thiu cng ph i 10000m2 . Con s ny qu ln i vi nhm 170 doanh nghip cha nhn chng ch, v h u l doanh nghip va v nh, c s sn xut th s, vn cha vt qua 7 t ng. Cc doanh nghip ny ang chim trn 50% th phn c nc. Hn na, cc vn khc nh khng in, nc, h thng thot nc thi, phng tin vn chuyn, vn ti ti a phng cng l nhng thch thc dai dng cho nhiu doanh nghip va v nh. - iu kin v sinh c bn: Cc chng trnh thc hnh v sinh tt hu nh thiu trong cc doanh nghip thc phm va v nh. H i din vi nhiu kh khn v vic khng mt bng nh xng v trang thit b, nh ca khng sch s, trang thit b c v bn, nhn vin thiu o to. Th m ch ti mt s vng, cc doanh nghip cn kh khn trong vic c c ng cung cp nc sch v ng dn thot nc thi. Hn na, cc doanh nghip va v nh thng kh c th c c cc ngun cung cp nguyn liu vi gi c ph hp m tin vy. Kh khn lin quan n nhn lc - Nhn thc v chuyn mn: Ngi ch v ngi vn hnh cc doanh nghip thc phm va v nh Vit Nam c th thc c vn an ton v sinh thc ph m. Tuy nhin h qu bn rn vi cc cng vic kinh doanh m khng nh n thc c tm quan trng ca vic p dng cc h thng qun l an ton thc ph m. Trong nhiu trng hp, thm ch h bit c t m quan trng, nhng cc doanh nghip vn thiu nng lc chuyn mn vn hnh h thng qun l an ton thc phm hiu qu.

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- Gio dc v o to: Hiu bit v cam kt ca ban lnh o l v cng quan trng ngay c khi nhn vin doanh nghip vn hnh h thng an ton thc ph m hiu qu. Rt nhiu khi nim v nguyn l ca qun l an ton thc phm mi m i vi ngi lao ng d lm vic nhiu nm trong ngnh vy nn cn c s gio dc, o to thch hp nu mun thnh cng. - Tr gip k thut: Cc doanh nghip thc phm va v nh thiu chuyn mn k thut cn thit cho vic p dng v vn hnh h thng qun l an ton thc ph m. H cn s tr gip chuyn mn t bn ngoi, c bit trong vic xc nh cc cht nguy hi c trong thc phm, to h thng truy tm ngun gc hiu qu, thit lp cc hnh ng khc phc, xc nh cc ch tiu k thut cho sn ph m v nguyn liu, tin hnh o lng v phn tch. - Ngun nhn lc: Cc doanh nghip thc phm va v nh c ngun v n nh, do vy h thng ki m sot rt cht mi chi ph. Ngun kinh ph tr cho lao ng thng him khi vt qu ngun ngn sch chy cng vic kinh doanh hng ngy. iu ny gy kh khn cho vic thu cc nhn lc cn thit ti n hnh h thng qun l an ton thc phm cng nh o to nhn vin. - Cc yu t tm l: Cc doanh nghip thc phm va v nh chu nhiu ro cn tm l khi p dng h thng qun l an ton thc phm hn cc doanh nghip thc phm ln. Bn cnh cc ro cn tm l thng thng nh yu cu ca khch hng, p lc thi gian v chi ph, thiu ng lc v s tin tng rng mt h thng qun l an ton thc phm l cn thit to nn s khc bit trong cng vic kinh doanh ca h, cc doanh nghip va v nh cn chu thm cc rng buc tm l khc nh thiu nim tin nng lc c nhn, tr tr do khng kh nng vt qua thi quen ca mt li thc hnh c do thiu mong mun thay i v thiu s ng tm do khng nhn nhn c vic p dng mt h thng qun l an ton thc ph m c th to ra cc sn phm an ton hn nh th no. Cc doanh nghip thc ph m va v nh thng tin rng h to ra cc sn phm an ton ri m khng cn n mt h thng qun l an ton thc phm. iu ny c nhn nhn nh mt s thiu cam kt ca lnh o. Kh khn do thiu mi trng tr gip - Vn ti chnh: Cc kh khn v ti chnh l nhng ro cn thc t cho cc doanh nghip va v nh khi p dng mt h thng qun l an ton thc phm. S tr gip t Chnh ph v cc t chc thng mi khng to nn mt s thay i trong cc doanh nghip ny. Cc h thng qun l an ton thc phm d nhin l mang li nhng li ch to ln cho chnh ph bng cch tit kim chi ph cho vic cha tr v chm sc sc khe cng ng. Tuy nhin, gi tr ca vic ny vn cha c nh gi y khi ng cc khon u t. Trong khi , chi ph cho Trang 10

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vic xy dng v p dng mt h thng qun l an ton thc phm c th cao hn nhiu so vi d ton ban u, nh thu t vn bn ngoi v thi gian o to nhn vin c th nh hng trc tip ti cc cng vic kinh doanh hng ngy c a cc doanh nghip va v nh. - Cc yu cu php l: Cc yu cu php l thng l mc ti thiu m bo cc iu kin v sinh v an ton thc ph m. Khi khng c ch nh t chnh ph v vic trin khai p dng h thng qun l an ton thc ph m, cc doanh nghip thc ph m va v nh khng cm thy cn thit v bt buc trin khai h thng ny. - thc kinh doanh v thi ca cc t chc cng nghip v thng mi: Cc chng ch h thng qun l an ton thc phm c yu cu nh nhng chic v vo ca cho cc th trng thng mi quc t. Cc doanh nghip thc ph m ln bi l do phi tin hnh p dng cc h thng qun l an ton thc phm. Cc doanh nghip va v nh ch yu l cung cp sn phm cho th trng trong nc, cc khch hng, ngi bn l v ca hng n a phng, nn khng tri n khai p dng h thng qun l an ton thc phm do khch hng ca h khng yu cu chng ch. - Nhn thc ca khch hng: Rt nhiu ngi tiu dng trong nc c bit nhng khu vc ngho, km pht trin khng nhn thc c tm quan trng ca vn an ton thc phm cng nh cc cht gy hi cho sc khe c trong thc ph m. 9.3. ngha vic p dng GMP i vi nh sn xut: Mt doanh nghip p dng tiu chun GMP s ci thin c c bn v ton din iu kin v sinh an ton ca c s sn xut cng nh cc hot ng sn xut v p ng cc yu cu ca php lut v qun l v sinh an ton thc phm. Bn cnh cc li ch theo sau m GMP em li l: Tiu chun ha iu kin v sinh v hot ng kim sot v sinh nh xng, con ngi, sn xut

To iu kin thun li cho vic trin khai HACCP, ISO22000 Gim phn ln nguy c ng c, kin co, phn nn ca khch hng Tng cng uy tn, s tin cy, s hi lng ca nh phn phi, khch hng. Ci thin hot ng tng th ca doanh nghip

Khi sn phm c chng nhn c ngha l sn phm c cc ch tiu cht lng, v sinh an ton ph hp vi qui nh trong tiu chun (hoc quy chun k Trang 11

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thut) c lin quan. iu ny to lng tin ca khch hng i vi nh sn xut, gp phn nng cao uy tn ca nh sn xut, v th gip cho nh sn xut d dng trong vic m rng th trng v thuyt phc khch hng chp nhn sn phm. Nhng sn phm c chng nhn s c u th cnh tranh i vi nhng sn phm cng loi nhng cha c chng nhn, chnh v vy m GMP tr thnh cng c tip th hu hiu cho nh sn xut. Chng nhn sn phm cng l mt cch thc kim sot sn xut, trn c s s gip nh sn xut gi n nh cht lng; ci tin nng sut; gim s lng ph v gim t l sn phm b ph phm. i vi ngi tiu dng: Sn phm c chng nhn cung cp s m bo c lp ca bn th ba cho ngi tiu dng, l sn phm c chng nhn theo mt phng thc ph hp bao gm: th nghim; nh gi iu kin m bo cht lng; gim st v kim sot. Ngi tiu dng khng cn thit phi tn chi ph cho vic thc hin nhng th nghim i vi sn phm c chng nhn ph hp vi tiu chun v lun yn tm v sn phm c sn xut trong iu kin m bo cht lng. i vi C quan qun l: Sn phm c chng nhn p ng yu cu qun l v bo v an ton/sc khe cho ngi tiu dng, bo v mi trng. - Tt c cc qu trnh quan trng u c xem xt, xy dng th tc, ph chun v thc hin m bo s n nh v ph hp vi cc c im k thut. - Cc iu kin phc v cho qu trnh sn xut c xc nh v a ra cc yu cu thc hin, ki m sot mt cch r rng. - Chi ph thp hn do qu trnh sn xut v vic ki m sot cht lng c chun ha, cc yu cu ti thiu v nh xng, thit b c xc nh r rng u t hiu qu (khng u t qu mc cn thit gy lng ph hay u t khng ng yu cu). - Ci thin tnh nng ng, trch nhim v hiu bit cng vic ca i ng nhn vin, tng cng s tin cy ca khch hng v c quan qun l. - t c s cng nhn Quc t, bo v thng hiu ca sn phm, tng kh nng cnh tranh v tip th, tng c hi kinh doanh, xut khu thc phm. - Chuyn t kim tra c lp sang cng nhn, tha nhn ln nhau, p ng c tin trnh ha nhp v i hi ca th trng nhp khu. - m bo quyn li ngi tiu dng v cht lng sn phm v m bo v sinh an ton - To s nht qun trong qun l v gi m thiu cc s c ri ro trong sn xut v tiu th. - Gia tng s tin cy ca khch hng v sc cnh tranh ca doanh nghip. Trang 12

Qun tr cht lng-GMP 10. Thc tin v p dng GMP Vit Nam

GVHD: H Thin Thng Minh

Nhn thc c tm quan trng ca vic p dng tiu chun GMP c rt nhiu doanh nghip khn trng tin hnh, s dng cc ngun lc sn c v huy ng ngun lc bn ngoi tin hnh p dng chun GMP vo quy trnh sn xut.Tuy nhin trong qu trnh thc hin th c nhng doanh nghip khng thc hin ng theo quyt nh ra ca B Y t.Tnh ti thi im 09/09/06 ( sau gn 2 nm thc hin) ch c 42 c s t GMP-ASEAN v 18 DN t GMPWHO trong 174DN, s cn li th qu trnh xy dng chun vn rt chm chp. Trong 2 nm, t 2008 n 2010 cht lng b xung cp ht sc trm trng. Nguyn nhn l sau 2 ln c gin l trnh thc hin GMP, c khng di 60% DNSX thuc bit trc s khng th cnh tranh v buc phi ng ca vo nm 2010 nn hu nh khng u t ci to mi thit b, khin cht lng sn phm rt km. II. GII THIU V CNG TY NAM DC 1. Gii thiu v cng ty Cng ty c phn Nam Dc c bit n vi nhng sn phm mang li sc khe cho ngi tiu dng, iu tr cc loi bnh v tai mi hng, tim mch, gan mt ngoi ra cn c nhng sn phm dng lm p, nhng sn phm dnh ring cho tr em. Cng ty Nam Dc l mt trong nhng cng ty sn xut dc phm ln nht Vit Nam.Vi slogan: t ho thuc Nam ngi Vit , cng ty c phn Nam Dc mun nhn mnh mt iu ngi vit dng thuc vit, thuc vit vn xa th gii. Khi m ngoi th trng c nhiu loi thuc nhp t cc quc gia khc th vic dng ngun nguyn liu t nc mnh sn xut nn nhng loi thuc l iu ng t ho, khng ch gip ngi dng tr khi bnh m cn gim bt chi ph thuc . i vi cng ty Nam Dc kinh doanh l em li gi tr thc s, li ch thc s cho x hi, t x hi ln hng u trong sc khe ngi dng l quan trng nht. Li khen ca khch hng l thc o thnh cng ca doanh nghip.Cng ty Nam Dc cam kt gi gn v pht trin tinh hoa Y hc c truyn Vit Nam lun mang n cho ngi s dng trong v ngoi nc sn phm c cht lng phng v tr bnh cao, an ton, tin dng, c li ch cho cng ng. Cng ty Nam Dc lun c v tinh thn yu qu v s dng thuc nam ca ngi vit. p li s tin cy ca ngi dng cng ty Nam Dc t mc tiu phn u tr thnh cng ty dc phm danh ting, chuyn nghip, ng cp hng u Vit Nam v thuc tho dc v thc phm chc nng c ngun gc thuc nam.

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Qun tr cht lng-GMP 2. Lch s cng ty

GVHD: H Thin Thng Minh

Cng ty c phn Nam Dc c thnh lp vo ngy 01/01/2004, c S K hoch v u t thnh ph H Ni chnh thc cp giy chng nhn ng k kinh doanh ngy 04 thng 03 nm 2004, c vn iu l 3.500.000.000 ng (Ba t nm trm triu ng ), vi 23 c ng sng lp. Tr s chnh ti s 02, ngch 26/31, ng 26 Nguyn Hng, phng Lng H, ng a, H Ni. Lnh vc kinh doanh thi im ca cng ty l kinh doanh, i l mua bn, k gi dc ph m, m phm, thc ph m; trang thit b y t; T vn, o to v dch v chuyn giao cng ngh dc, m phm. Ngy 07 thng 02 nm 2005, Cng ty thay i ng k kinh doanh ln mt, trn c s cc ngnh ngh c v b sung thm cc ngnh ngh nui trng, thu mua ch bin dc liu v kinh doanh dc liu. Thng 9 nm 2006, Cng ty hon thnh vic xy dng nh my sn xut dc phm theo tiu chun GMP - WHO, GSP, GLP v l mt trong nhng doanh nghip u tin pha Bc c nh my sn xut dc phm t tiu chun ny. Thng 05 nm 2007, Cng ty thay i giy chng nhn ng k kinh doanh ln th t vi s vn iu l l 41.688.000.000 ng Ngy 25 thng 06 nm 2007, Cng ty chnh thc tr thnh cng ty i chng. Sau khi hon thnh nh my t tiu chun GMP. Nam Dc tp trung sn xut a dng cc mt hng tn dc v ng dc tin vo th trng bo hi m bnh vin. Tuy nhin, sau khi cc sn ph m ca Nam Dc bt u xm nhp c vo hu ht cc h thng bo him trn ton quc th gp phi cn khng hong ti chnh m nh cao khng hong l cui nm 2008. Thng 06/2009: i hi c ng vi vic quyt nh chin lc ch tp trung chuyn su chin lc pht trin thuc Nam, t b sn xut cc sn phm tn dc. Thng 11/2009: Bt u xy dng li h thng mi hon ton, bt u t min Bc v hon thin dn h thng phn phi v cng thi i m ny thc hin tng vn iu l ln 56.800.000.000 ng T 11/2009 n nay, Nam Dc chng kin s pht trin mnh m v vt bc trn trong sn xut v ngoi th trng. Mt s sn phm ca Trang 14

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cng ty tr thnh nhng sn phm ng u trong dng sn phm. Thng hi u Nam Dc c pht trin vng mnh v uy tn trong cng ng v gii chuyn mn. Nm 2010, Nam Dc vinh d c th tng chnh ph trao tng gii bc cht lng quc gia. V vinh d hn, nm 2011 Nam Dc c th tng trao tng gii vng cht lng quc gia v tr thnh doanh nghip dc ph m u tin v duy nht t c gii thng ny. Cc sn phm ca Nam Dc cng nhiu ln nhn c huy chng vng cht lng do B cng thng, B khoa hc cng ngh v nhiu b ngnh khc trao tng. Ton b cc tiu chun m nh my ca Nam Dc c cng nh n nh: GMP - WHO, ISO 9001:2000, ISO 14000:2004, HACCP v SA 8000 hp thnh b tch hp tiu chun IMS (Intergrated Management System) tin tin ca th gii v cht lng sn phm c lm ra t nh my t c trnh ny c ton th gii cng nhn. Tnh ti thi im hin nay, cha c doanh nghip dc no Vit Nam (k c khi doanh nghip trong nc v khi c vn u t nc ngoi) t c h tch hp tiu chun tin tin ca th gii. iu ny khng nh tm nhn v s mnh ca Nam Dc l c a nhng sn phm c ng cp th gii v cht lng vt tri n tay ngi dn Vit Nam, gp phn nng cao tm sc khe ton dn tc.

GMP-WHO

SA 8000: 2001

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9001:2008 v HACCP

ISO 14000:2004

B tch hp tiu chun MIS

3. S t chc v ban lnh o thc hin c s mnh v t c tm nhn m cng ty ra th c cu t chc v ban lnh o l nhng nhn t v cng quan trng, lnh o sng sut v c cu t chc cht ch s gip Nam Dc pht trin mnh m nhanh chng v bn vng hn. Cng nh nhng cng ty c phn khc, ng u Nam Dc l i hi ng c ng, hi ng qun tr, di l cc gim c v cc phng ban Di y l s c th v c cu t chc ca Nam Dc.

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4. Knh phn phi a cc sn phm thuc ca mnh n vi tt c ngi tiu dng trong v ngoi nc th i hi Nam Dc phi c mng li phn phi rng. Tri qua qu trnh tm kim, c gng, ly ct mc l a im cng ty t phn phi rng ra khp c nc v thm ch ra nc ngoi. Knh phn phi ca cng ty Nam Dc ch yu l nh thuc, cc cng ty dc phm, ri rc t nam ra bc . Cng ty Nam Dc phn phi nhiu nht khu vc min bc v min nam. Vi mng li dy c nh vy Nam Dc d dng em sn ph m ca mnh n ngi dng qua Nam Dc c th t c nhng mc tiu ra.

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5. Chin lc pht trin ca Nam Dc: - Mt l tr thnh i din tiu biu cho thuc Nam hin i ha. + Tin phong v dc liu sch v chun ha ti Vit nam vi mt s dc liu nh B bnh, mm u nnh, Dy tha canh, a long, Rn h mang, Ta dng, Dip h chu v.v + Bo tn v pht huy gi tr vn ha truyn thng, di sn kin thc ng cha trong sn xut v kinh doanh. - Hai l chin lc sn phm + Pht trin ti thiu 05 sn phm dn u th trng c cht lng cao, mu m p tin dng, c mt mi gia nh Vit nam, c ngi dn Vit nam bit n s dng, tin cy. - Ba l chin lc nhn s + i ng lnh o: c dy, tm sng, tm cao, chuyn nghip; C s mnh v l tng sng cao p, c gi tr v li sng o c, uy tn, gng mu, tin phong; Khng ngng trau di tm cao nhn thc v tch ly kin thc, rn luyn k nng.

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GVHD: H Thin Thng Minh

+ Xy dng bn sc vn ha c trng v mnh m theo tm gi tr ct li ca doanh nghip. Lin tc p dng v cng c cc gii php qun tr tin tin v khoa hc pht trin tc phong lm vic chuyn nghip; Lin tc xy dng m hnh gi o to v t o to cn b cng nhn vin c s pht trin v tr tu; Chia s v mi mt mi thnh vin c m p v tinh thn; Lan ta nim am m thuc nam, cy c, lun i tm v gn gi nhng bi thuc hay, pht huy tinh thn dn tc Vit. + S tm huyt ca con ngi Nam Dc v tinh thn "khng c g l khng th", lun kht vng tr thnh i din s 1 cho ngnh ng dc Vit nam. Khng dng li v hi lng vi nhng thnh qu t c, lun c kht vng chinh phc nhng mc tiu th thch. - Bn l mang li li ch thc s cho sc khe cng ng v x hi : Nam Dc tn ti nh mt thc th c vai tr x hi nhng cng mang tnh o c. Ngoi mc tiu mang li li ch thc s cho khch hng, cn b cng nhn vin, cng ty s lun th hin trch nhim i vi cng ng v x hi vi nhng hot ng ph hp vi nh hng pht trin ca mnh. III. DY CHUYN SN XUT CNG TY T CHUN GM P-WHO: 1. Tng quan v dy chuyn sn xut ca cng ty Nam dc: C 3 dy chuyn sn xut
- Dy chuyn sn xut thuc tn dc + Dy chuyn sn xut thuc vin + Dy chuyn sn xut thuc nc - Dy chuyn sn xut thuc ng dc. - Dy chuyn chit xut.

2. Dy chuyn sn xut t chun GMP-WHO 2.1. Phn tch cc bc p dng GMP-WHO ca cng ty Nam dc: Bc 1: Tp hp cc ti liu cn thit, bao g m: - Cc quy nh ca php lut hin hnh: Quyt nh s 05/TC- Q ngy 0401-1997 ca Tng cc tiu chun o lng cht lng; ng k chng nhn do Trung tm chng nhn ph hp QUACERT ban hnh; Th tc gii quyt khi u ni do QUACERT ban hnh.

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Bc 2: Lp k hoch, phn cng c nhn ph trch v xc nh ph m vi p dng GMP a. Phm vi p dng

Ton b dy chuyn ca Nam Dc. Tnh n nm 2009 th ch tp trung sn xut thuc ng Dc.

b. Phn cng c nhn ph trch. Ti nh my, b phn kim tra cht lng, chu trch nhim kim tra m bo cht lng ca nguyn liu u vo, cht lng bn thnh phm trong qu trnh s n xut, ki m tra cc ch tiu ho, l, vi sinh ti phng Lab trong Nh my v nh k gi kim c quan chc nng bn ngoi. Tt c cc cn b c trch nhim u phi c bn m t cng vic c th. Nhi m v ca h c th c u quyn cho cc cn b cp ph c trnh t yu cu. Trng b phn sn xut c nhng trch nhim sau: +m bo sn phm c sn xut v bo qun theo ng h s ti liu ph hp c c cht lng yu cu. +Ph duyt cc hng dn lin quan n thao tc sn xut v m bo chng c thc hin mt cch nghim ngt. +m bo h s sn xut c nh gi v k bi mt ngi c giao nhi m v ny trc khi chng c gi ti b phn kim tra cht lng; +Kim tra vic bo tr nh xng v my mc thit b lin quan n sn xut; +m bo rng vic thm nh ph hp c thc hin. +m bo rng vic o to ban u v o to lin tc cho nhn vin c thc hin v vic o to c iu chnh ph hp vi nhu cu. Trng b phn kim tra cht lng c nhng trch nhi m sau: +Duyt hoc loi b nu thy ph hp, nguyn liu ban u, nguyn vt li u bao gi, sn phm trung gian, bn thnh ph m v thnh phm. +nh gi h s l +m bo tt c cc php th cn thit u c thc hin; +Ph duyt cc tiu chun, hng dn ly mu, phng php th, v cc quy trnh kim tra cht lng khc; +Ph duyt v theo di vic kim nghi m theo hp ng;

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Qun tr cht lng-GMP

GVHD: H Thin Thng Minh

+Kim tra vic bo dng c s, nh xng v my mc thit b; +m bo cc thm nh ph hp c thc hin; +m bo vic o to ban u v o to lin tc cho nhn vin b ph n ki m tra cht lng c thc hin v vic o to c iu chnh cho ph hp vi nhu cu. B phn Dch v khch hng ca Cng ty thng trc tip nhn v gii quyt kp thi tt c cc phn nn, khiu ni ca khch hng v cht lng sn ph m v dch v ca Cng ty. Bc 3: Thit lp cc th tc, quy nh, tiu chun cho tng cng on v hun luyn cn b cng nhn vin. a. Thit lp cc th tc, quy nh, tiu chun cho tng cng on Vic qun l cht lng sn phm c thc hin ng b xuyn sut qu trnh sn xutca Cng ty, t nhp nguyn vt liu n quy trnh cng ngh v lu kho sn phm: +Kim tra cht lng nguyn vt liu: nguyn vt liu u vo cho sn xut u c ki m tra k trc khi nhp kho m bo ng nhng tiu chun quy nh. Trong thi gian nguyn liu c lu kho ch sn xut, b phn ki m nghim c trch nhim thng xuyn theo di, pht hin nhng bt thng v cht lng ngh x l kp thi. +Kim tra cht lng sn phm trong qu trnh sn xut: kim sot cht ch quy trnh sn xut, m bo ti cc khu s n xut, cc thao tc, th tc c ti n hnh ng theo qui trnh k thut nhm m bo cht lng bn thnh phm qua tng cng on v khng sn phm cui cng km cht lng n tay ng i tiu dng. +Kim tra cht lng sn phm trong qu trnh lu kho: nh k, b ph n ki m tra cht lng tin hnh kim tra thng xuyn cht lng hnh ha trong kho, lp bo co v xut bin php x l i vi cc trng hp bt thng v cht lng. +Thc hin theo di cht lng sau sn xut: Cc l hng u phi c ki m tra cht ch v theo di theo h thng m s v h s nhm truy tm ngun gc sn phm trong trng hp c s c xy ra i vi khch hng khi s dng sn ph m ca Cng ty. +Cc s liu v phn nn, khiu ni ca khch hng m B phn Dch v khch hng thu v phi c thng k v s dng ra cc quyt nh ci tin lin quan. Trang 21

Qun tr cht lng-GMP b. Hun luyn cn b cng nhn vin.

GVHD: H Thin Thng Minh

Cng nhn v cn b qun l sn xut nh k c hun luyn kin thc v thc hnh v v sinh an ton thc phm, vn hnh my mc, thit b, m bo v ngy cng nng cao cht lng cng vic ni chung v cht lng sn phm ni ring. Khi vo nh my, trc tin l cng nhn phi c m bo v tc khi thao tc vi cc sn phm, t lc bt u cho n khi sn phm c hon thnh.V sinh tay, bn cnh mi nhn vin vo khu vc sn xut cn mc qun o bo h ph hp vi thao tc sn xut s thc hin. Ring gng tay s c s dng khi mang, vc nhng ha cht nguy hi m; hoc dng trong trng hp sn phm d b nhim khun. Bc 4: Thc hin v theo di. Bc 5: Gim st vic thc hin: nh gi hiu qu, ci tin. 2.2. Phn tch quy trnh sn xut p dng GMP-WHO Nhn s v o to Cn b lm vic ti nh my c y sc khe, kinh nghim, c o to y cc k nng trnh chuyn mn m bo thc thi tt nhi m v c giao.C vn bn hng dn, phn cng quyn hn r rng ca cc cn b cc b phn, cn b gim st tng khu, tng tin trong dy chuyn sn xut. ng thi, thng xuyn nh gi y , cng bng nng lc, kin thc ca cc nhn vin. Vic o to c thc hin lin tc v hiu qu o to c nh gi nh k. H s o to c lu gi. o to kin thc chuyn su cho cc cn b ch cht theo tng giai on: k nng xy dng v trin khai p dng h thng ti liu, k nng nh gi ni b v k nng gim st, thm nh GMP. Nh xng, my mc, thit b Nh my sn xut vi quy m trn 10.000m2 t ti khu th Yn Ha, C u Giy, H Ni , y l mt d n ln trong ngnh dc Vit Nam. Vic thit k nh my c tin hnh cn c vo tiu chun xy dng v v sinh ca Lin minh Chu u v T chc Y t th gii (WHO) nhm m bo p ng cc tiu chun v sinh cng nghip v sn phm t cht lng cao. Vic khi cng xy dng d n c tin hnh vo thng 07/2005, sau hn mt nm xy dng, nh my c khnh thnh v c Cc qun l Dc B Y t cp giy chng nhn t tiu chun GMP WHO (Good Manufacturing Practice - Thc hnh tt sn xut thuc).

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Qun tr cht lng-GMP

GVHD: H Thin Thng Minh

Trang b h thng my mc tin tin vi cng sut ln nhp khu t Trung Quc - Quc gia s mt trn th gii v cng ngh sn xut thuc t tho dc. y l h thng my mc hin i, ng b v l dy chuyn chit xut hin i nht Vit Nam. y l ni tip nhn dc liu t kho dc liu ch bin dc liu u vo ng thi l ni cung cp cc bn thnh phm phc v cho cc dy chuyn sn xut tip theo. Ni ct cng sut 2 x 4 tn/ h c din tch l: 590m2 c thit k v t bn trong khu chit xut.

Hnh nh cc trang thit b cao cp t nc ngoi Trang thit b ti nh xng c b tr lp t mt cch hp l, ph hp vi tng cng on, tit kim thi gian trong

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Qun tr cht lng-GMP khu vn chuyn, a nguyn liu vo quy trnh. H thng iu ha trung tm:

GVHD: H Thin Thng Minh

- My lnh trung tm: Carrier - S dng my lnh hp th (Absorption Chiller) vi cng ngh tin tin nht hin nay. S dng nng lng t than ca l hi tit kim nng lng. Cng sut lm lnh 1048 KW (~3.500.00 BTU). Cng ngh my lm lnh hp th s dng cp dung mi cht lnh LiBr / H2O khng nh hng n mi trng. - B x l khng kh AHU (Air Handing Units): Lp t cc AHU cho cc khu vc trong sn xut gm cc h thng lc v siu lc c hiu sut 99,99% s dng cho cc phng sch. V sinh H thng cp nc: Nc cho hot ng sn xut ca Cng ty c ly t h thng nc my ca thnh ph, qua h thng cp nc ca Cng ty cung cp cho cc hot ng sinh hot ca CBCNV v vo cc h thng x l nc cung cp cho sn xut: - H thng nc tun hon lm mt vi lu lng 275m3/ gi, c x l bng thit b lm mm in t v trao i cation. - H thng cp nc cho l hi: Nc cp t h thng ca nh my trc khi cp cho l hi c qua b x l cation. - H thng x l nc RO: Vi cc h thng lc hp th, hp ph, h thng trao i Ion. H thng thm thu 2 ln v siu lc, tit trng, nc RO t tiu chun nc tinh khit ca GMP WHO. - H thng x l nc thi: (WSZ A5) H thng x l nc thi c thit k ngm di t. Nc thi theo ng ng dn, tp trung vo b cha, x l bng phng php vi sinh lng lc vi cng sut 5m3/ gi. Nc thi u ra t tiu chun quy nh (BOD = 20mg/L) Cng ngh my lm lnh hp th s dng cp dung mi cht lnh LiBr / H2O khng nh hng n mi trng. Lp t cc AHU cho cc khu vc trong sn xut gm cc h thng lc v siu lc c hiu sut 99,99% s dng cho cc phng sch. Vic v sinh nh xng lun c thc hin thng xuyn, nh k u c t tit trng h thng cung cp khng kh v cc phng sn xut.

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Qun tr cht lng-GMP Nguyn liu

GVHD: H Thin Thng Minh

Ngay t khu la chn nh cung cp v kim tra nguyn liu u vo, cng ty Nam dc tun th nghim ngt quy trnh cht lng, m bo cc ch tiu v ho l, vi sinh, quy cch ng gi, cng nh cc chng nhn v ngun gc. Nam Dc vi nh hng tin phong pht trin tinh hoa thuc Nam, nh n thc c t m quan trng ca cht lng dc liu, coi l yu t then cht c sn ph m thuc tt. V cng t , Nam Dc tp trung ht sc mnh nghin cu su 1 s dc liu thuc Nam, to bc t ph v cht lng sn phm, in hnh l cy u nnh quen thuc nhng c gi tr rt ln trong y hc. Vi m hnh sn xut cht ch gn b gia 3 Nh: Nh Khoa hc - Nh Nng Nh Doanh nghip, nh my Nam Dc p ng vic lm v thu nhp cho ngi nng dn, ng thi p ng nhu cu s dng nguyn liu sch, an ton vi 100% thnh phn t thin nhin kt hp cng ngh chit xut tin tin. Kim sot quy trnh ch bin to thnh phm H thng kim sot bng hnh nh: H thng camera c lp t tt c cc phng trong khu vc sn xut, phng hp, hi trng, cng ra vo. H thng iu khin trung tm bao gm 3 my ch lu tr cc hnh nh gim st v hot ng sn xut v cc hot ng lm vic ca ton b cn b cng nhn vin cng ty. Tt c nhng hnh ng c coi l li trong sn xut c lu tr v pht li vo cc bui cho c sng th hai hng tun CBCNV rt kinh nghim v hc tp. Hnh nh h thng camera c lp t:

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Qun tr cht lng-GMP

GVHD: H Thin Thng Minh

Kim sot cht lng Phng Kim tra cht lng nm tch bit hn vi khu vc sn xut gm c: + Phng Kim nghim vi sinh: c trang b thit b to dng khng kh bt nh hng, to iu kin kim tra v trng v mt s kim tra vi sinh khc. p sut mi khu vc trong phng l khng ging nhau trnh hin tng pht tn nhim. Cc yu t nh hng kh, tc kh, hiu qu lc HEPA v thit b gim st mi trng thng xuyn c kim tra. + Phng kim nghim ha l: c thit k vi khng gian rng, trnh hin tng pha trn v lan truyn nhim. Phng c trang b t ht ht cc dung mi v ha cht c hi sau th nghim.

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Qun tr cht lng-GMP

GVHD: H Thin Thng Minh

+ Phng lu mu: lu tr cc mu nguyn vt liu th (bao gm cc thnh phn dc v t dc), bn thnh phm v thnh phm. Nhit v m ti ni ny c kim sot cht ch. + H thng x l kh thi phng kim nghim: Mt cng on ht sc cn thit v khng th thiu ca qu trnh phn tch cc loi mu ca Phng Th nghim l chit, tch cc cht trong mu vt, chuyn chng sang mt trng thi thch hp cho cc cng on phn tch tip theo nh sc k, quang ph, trc quang, ha hc, ha l... Thng thng, l trng thi ha tan trong cc h dung dch, dung mi trng thi lng, d bay hi. Vi h thng qut ht v t ht ti cc phng th nghim v cc kho ha cht, ton b kh thi ca phng th nghim c thu gom ti hp thu gom, gim m iu tit lu lng cho qut ht kh thi cng sut 4,5KW khng gy ra ting n v rung. Thng qua ng ng dn kh thng thng bng ng PVC (chu c ha cht), kh thi t hp thu gom c a vo thit b lc hp ph v thit b lc hp th (s dng cc cht hp ph v dung dch hp th ph hp). Kh sau khi ra khi thit b hp th s c thi thng vo mi trng theo tiu chun quy nh. Bao b ng gi Bao b ng gi lun lun c kim sot cht ch iu kin sn xut m bo yu cu v sinh. Quy trnh ng gi sn phm c lm hon ton bng dy chuyn hin i, tin tin, tit kim c thi gian, tnh chnh xc cao Bo qun v phn phi Kho nguyn ph liu:

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Qun tr cht lng-GMP

GVHD: H Thin Thng Minh

-H thng nh kho theo chun GPS( thc hnh t bo qun thuc) -Lnh vc p dng: Tn tr, vn chuyn v phn phi 3. nh gi thc trng p dng GMP ti Nam Dc Hu nh cc quy trnh c Nam Dc thc hin kh tt, tuy nhin v n cn tn ti mt s vn sau: Th nht: Cha c cc chng trnh o to kin thc v GMP cho Cng nhn vin tr i ng qun tr. a phn cc hot ng o to mang tnh g n kt t chc, thng l cc kha k nng mm, pht trin hot ng bn hng. Do khng phi tt c cc thnh vin c a doanh nghip u hiu r vai tr v tm quan trng ca h thng t gic thc hin cc quy nh, hiu r v GMP. Th hai: Cn th ng trong vn x l sai st trong qu trnh sn xut. Cha kim sot c cht lng ng thi i m, ngay ti phn xng sn xut. Cc sai st c a nhn vin ch dng li vic rt kinh nghim v hc tp, cn thit c nhng bin php c th x l sai st trong qu trnh sn xut. Nhn vin phi c trau di y kh nng chuyn mn, c th nhn bit v khc phc li sai ngay khi pht hin. Th ba: Do h thng nh xng my mc hin i v hu nh mi hon ton, cha c sai st nhiu trong qu trnh sn xut m doanh nghip cha thc s quan tm n vic bo dng. Cha c cc cuc o to chnh thc v c cu vn hnh ca cc loi my mc, cch khc phc nu c bin c xy ra

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Qun tr cht lng-GMP 4. ngha ca vic p dung GMP ti Nam Dc

GVHD: H Thin Thng Minh

Trc s trn lan ca thuc gi, thuc km cht lng th cht lng thuc ang l vn m tt c cc nc trn th gii quan tm.Nhng quy inh m GMP a ra c vai tr quan trng i vi vic sn xut thuc m bo cht lng. p dng GMP vo doanh nghip gp phn nng cao sc khe con ngi, gi m thiu cc v ng c, sc thuc, to nim tin i vi khch hng, trch tn tht kinh t v nhim mi trng. IV. KT LUN Mt doanh nghip p dng tiu chun GMP s ci thin c c bn v ton din iu kin v sinh an ton ca c s sn xut cng nh cc hot ng sn xut v p ng cc yu cu ca php lut v qun l v sinh an ton thc phm. L mt cch thc kim sot sn xut, trn c s s gip nh sn xut gi n nh cht lng; ci tin nng sut; gim s lng ph v gim t l sn phm b ph phm. Khi sn phm c chng nhn c ngha l sn phm c cc ch tiu cht lng, v sinh an ton ph hp vi qui nh trong tiu chun (hoc quy chun k thut) c lin quan. iu ny to lng tin ca khch hng i vi nh sn xut, gp phn nng cao uy tn ca nh sn xut, v th gip cho nh sn xut d dng trong vic m rng th trng v thuyt phc khch hng chp nhn sn phm. Nhng sn phm c chng nhn s c u th cnh tranh i vi nhng sn phm cng loi nhng cha c chng nhn, chnh v vy m GMP tr thnh cng c tip th hu hiu cho nh sn xut. V. TI LIU THAM KHO -Thng t 16/2011/TT-BYT, quy nh nguyn tc sn xut thuc t dc li u v l trnh p dng nguyn tc, tiu chun thc hnh tt sn xut thuc (GMP) i vi c s sn xut thuc t dc liu -Quyt nh 27/2007/Q-BYT ngy 19/4/2007 v vic ban hnh l trnh tri n khai p dng cc nguyn tc, tiu chun Thc hnh tt sn xut thuc" v nguyn tc Thc hnh tt bo qun thuc" -Quyt nh s 05/TC- Q ngy 04-01-1997 ca Tng cc tiu chun o lng cht lng. -Trang thng tin Cng ty c phn Nam dc www.namduoc.vn -Trang web: www.isovietnam.com.vn, www.gmp.com.vn www.vi.scribd.com/doc/39980282/Ap-Dung-GMP-GHP-HACCP

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Qun tr cht lng-GMP

GVHD: H Thin Thng Minh

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