GMP THC HNH SN XUT TT

1. Gii thiu chung 1.1. Gii thiu v GMP 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 , nhm m bo sn phm t cht lng v an ton. 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 sn 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 quy nh, th tc ca h thng GMP ca mi doanh nghip s khc nhau. 1.2. Lch s ra i 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 khon 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 sn xut v cc tiu chun ca sn phm ti cc doanh nghip c thc hin GMP phi ph hp vi cc tiu chun cng nghip, cc pht minh mi v cng ngh, khoa hc ngay ti thi im p dng. cGMP nhm nhc nh cc nh sn xut cn phi 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 phm 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 phm v M phm ti M. Nm 1996, cc nc thuc khu vc ASEAN ban hnh b tiu chun chung GMP - ASEAN cho sn xut dc phm v y t.

Nm 1996, 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 GHP Good Hygien Practice hoc GPP Good Pharmacy Practice Thc hnh nh thuc tt. Ti Vit Nam Nm 1997, Tng cc Tiu chun o lng Cht lng ban hnh Quyt nh 05/1997/TC Hng dn chung v nhng ni dung c bn ca GMP p dng trong cc c s sn xut thc phm. Nm 2004, B Y t ban hnh Quyt nh s 3886/2004/Q-BYT Trin khai p dng nguyn tc, tiu chun Thc hnh tt sn xut thuc (tn dc) theo khuyn co ca T chc Y t Th gii. Quyt nh yu cu n ht nm 2006, tt c cc c s sn xut thuc tn dc phi t GMP-ASEAN v n ht nm 2010 tt c cc doanh nghip sn xut thuc dng ngoi v thuc dc liu phi t GMP-WHO. Cng nm 2004, B Nng nghip v PTNT ban hnh Quyt nh s 08/2004/QBNN-TY ngy 30/03/2004 quy nh trin khai p dng cc nguyn tc, tiu chun Thc hnh tt sn xut thuc th y (GMP). Nm 2008, B Y t ban hnh Quyt nh s 5/2008/Q-BYT Quy nh cc c s sn xut thuc ng y phi p dng cc tiu chun thc hnh tt sn xut GMP nh c s sn xut thuc tn dc. Nm 2007, Th tng Chnh ph ban hnh Ch th s 06/2007/CT-TTg v vic trin khai cc bin php cp bch bo m v sinh an ton thc phm. Trong yu cu p dng GMP, GHP, HACCP trong sn xut thc phm v qun l an ton v sinh thc phm. 1.3. Tm tt v GMP 1.3.1. Phm vi v i tng kim sot ca GMP: - 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 sn xut, nh gi vic cung ng ca nh cung cp nguyn vt liu,
2

Cht lng sn phm: th nghim mu, Kim tra: nguyn liu, bn thnh phm, sn phm, 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

1.3.2. H thng ti liu ca GMP cho mi quy trnh sn xut bao gm: a) Cc Quy phm sn xut GMP: l quy nh cc thao tc, vn hnh trong cng ngh v thit b, quy nh thnh phn nguyn vt liu trong tng cng on sn xut, quy nh tiu chun ca sn phm c xy dng cho tng sn phm hoc nhm sn phm tng t, ca tng cng on hoc mt phn cng on sn xut trong quy trnh cng ngh ch bin thc phm. Ni dung Quy phm sn xut GMP c 4 phn: M t r yu cu k thut hoc quy trnh ch bin ti cng on hoc mt phn cng on sn xut , Nu r l do phi thc hin cc yu cu hoc quy trnh k thut nu, M t chnh xc cc thao tc, th tc phi tun th ti cng on hoc mt phn cng on sn xut nhm m bo t c yu cu cht lng, m bo an ton v sinh cho sn phm, ph hp v tiu chun k thut, Phn cng c th vic thc hin v quy nh gim st vic thc hin GMP.

Hnh thc Quy phm sn xut GMP: c th hin di dng vn bn, gm hai phn: Cc thng tin v hnh chnh (tn, a ch cng ty, tn sn phm hoc nhm sn phm, s v tn quy phm, ngy v ch k ph duyt ca ngi c thm quyn), Bn ni dung chnh nu trn.

b) Cc Quy phm v sinh chun SSOP (Sanitation Standard Operating Procedure): l cc quy trnh, th tc, hng dn lm v sinh ngun nc, nh xng, thit b ch bin v nhng b mt tip xc trc tip vi sn phm, v sinh c nhn v cc th tc kim sot v sinh ti ni sn xut. Quy phm v sinh chun c xy dng v p dng t c cc yu cu v v sinh chung ca GMP. Ni dung ca Quy phm v sinh chun gm 4 phn: Yu cu (hoc mc tiu) ca doanh nghip v cc quy nh ca c quan c thm quyn, - iu kin hin c: M t iu kin c s vt cht v v sinh thc t hin c ca doanh nghip, - Cc th tc cn thc hin: M t chi tit cc th tc v thao tc phi thc hin t yu cu v sinh,
3

Phn cng trch nhim thc hin v quy nh gim st vic thc hin SSOP.

Hnh thc mt Quy phm v sinh chun SSOP: c th hin di dng vn bn, gm hai phn: - Cc thng tin v hnh chnh (tn, a ch cng ty, tn sn phm hoc nhm sn phm, s v tn quy phm, ngy v ch k ph duyt ca ngi c thm quyn), Bn ni dung chnh nu trn. c) Cc ti liu khc: Vn bn quy nh ca php lut hin hnh, - Cc tiu chun, quy nh k thut v thit b, nguyn liu, sn phm, cc yu cu thao tc k thut, Cc bn v thit k nh xng, thit b, Cc yu cu, phn hi ca khch hng, Cc thng tin khoa hc mi, Kinh nghim thc tin ca doanh nghip, Kt qu nghin cu/th nghim mu

2. Mc ch Gip doanh nghip sn xut, gia cng, ng gi thc phm, dc phm, thit b y t c th thit k, xy dng, lp t thit b, nh xng m bo iu kin v k thut v qun l, nhm sn xut c sn phm c cht lng, p ng yu cu ngy cng kht khe ca cc th trng trong v ngoi nc. 3. ngha v li ch 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, kim sot mt cch r rng, Chi ph thp hn do qu trnh sn xut v vic kim 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.
4

4. Trit l

Lm ng ngay t u l cht lng nht, tit kim nht

Sn phm c to ra t mt qu trnh lin kt tt c cc cng on, cc b phn ca nh my sn xut. V vy, khng ch c cc thng s k thut ca cc cng on sn xut cn phi m bo chnh xc, m hiu qu hot ng ca cc b phn khc nh hnh chnh, nhn s, ti chnh, cung tiu ... cng c nh hng n cht lng sn phm. Tt c cc cng on, b phn u thc hin ng cc yu cu, thao tc, cht lng cng vic ... s m bo c cht lng sn phm. S kim sot, phng nga sai li hay s khng ph hp ngay t nhng cng on u tin s m bo gim thiu sn phm hng khng ng c, tit kim c thi gian, nhn lc...v tng nng sut. V vy tit kim c chi ph sn xut. Vic thit k nh xng, dy chuyn cng ngh sn xut, lp t thit b ng ngay t u chnh l p dng hiu qu GMP. 5. Nguyn tc: Tun th 8 nguyn tc ca Qun l cht lng: Nguyn tc 1: nh hng vo khch hng Nguyn tc 2: Vai tr ca Lnh o Nguyn tc 3: S tham gia ca mi ngi Nguyn tc 4: Tip cn theo qu trnh Nguyn tc 5: Phng php h thng Nguyn tc 6: Ci tin lin tc Nguyn tc 7: Quyt dnh da trn s kin Nguyn tc 8: Hp tc cng c li vi nh cung ng

p dng SSOP v GMP tt s gim thiu gnh nng cho p dng HACCP 6. Cc ni dung v yu cu ca GMP 6.1. Cc yu cu ca GMP - Yu cu v 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. Xy dng k hoch o to, hun luyn nghip v cho cn b, cng nhn. - Yu cu v 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. - Yu cu kim sot v sinh nh xng, mi trng: 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 him, kim sot sinh vt gy hi v v sinh c nhn, v sinh mi trng v nh xng. - Yu cu v kim sot qu trnh ch bin: cn xy dng cc quy nh v phng php ch bin, th tc, hng dn 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. - Yu cu v kim sot qu trnh bo qun v phn phi sn phm: Cn a ra cc yu cu v vic vn chuyn v bo qun sao cho thnh phm phi m bo khng b nhim bn bi cc tc nhn vt l, ho hc, vi sinh, khng thay i cht lng. . . v khng nhm ln sn phm, vn gii quyt khiu ni ca khch hng v thu hi sn phm sai li. 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 phm. 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. 6.2. Yu cu khi p dng GMP - 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 cc ca cc b phn c lin quan, T chc tt cng tc o to, trong :

+ o to kin thc c bn v GMP (nhp mn) cho tt c mi 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 ng 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 phm no c vn t cc ca hng hay kho d tr v x l cc sn phm ny. 7. Cc bc p dng: a. Tp hp cc ti liu cn thit, bao gm: - Cc quy nh ca php lut hin hnh, - Cc tiu chun nguyn liu, sn phm, cc yu cu thao tc k thut, - Cc yu cu, phn hi ca khch hng,
6

- Cc thng tin khoa hc mi, - Kinh nghim thc tin ca doanh nghip, - Kt qu nghin cu/th nghim mu b. Xc nh phm vi p dng GMP, c. Lp k hoch tin v phn cng c nhn ph trch, d. Thit lp cc th tc, quy nh, tiu chun cho tng cng on, e. Hun luyn cng nhn, f. p dng th, thm tra, g. Chnh sa thit b, nh xng, hun luyn cng nhn nu c s cha ph hp, h. Ph duyt p dng chnh thc, i. Gim st vic thc hin: nh gi hiu qu, ci tin.

8. V d minh ha
8.1. Phm vi kim sot ca GMP - Qun l nhn s, Nh xng, Thit b, Ngun nc, 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 sn xut, cung ng ca nh cung cp nguyn vt liu, Cht lng sn phm: th nghim mu, Kim tra: nguyn liu, bn thnh phm, sn phm, thao tc ca cng nhn, nh gi nh cung ng, v sinh, X l sn phm khng ph hp, X l rc thi, nc thi, kh thi (nu c), Bo dng thit b, hiu chun thit b o lng, Ti liu, h s thc hin .

8.2. Danh mc mt s ti liu cn bin son ca chng trnh GMP

a) Cc GMP: Yu cu v tr, thit k v xy dng nh xng, Yu cu thit k v lp t thit b, dng c ch bin, Quy nh v tuyn dng, o to nhn s,
7

Quy trnh ch bin, Yu cu k thut ca tng cng on ch bin, Vn hnh cc thit b, Tiu chun nguyn vt liu, bn thnh phm, sn phm cui Yu cu v pha ch, phi trn nguyn liu, Yu cu ly mu phn tch, phng php th, Yu cu hiu chun thit b, dng c o lng, Yu cu kim sot nguyn liu, sn phm, qu trnh sn xut, nh cung ng, Yu cu thng tin sn phm v ghi nhn, Yu cu thu hi sn phm sai li v x l, Quy nh bo tr thit b, Quy trnh hiu chun phng tin theo di, kim tra, & o lng, Quy nh v gii quyt khiu ni khch hng,

Yu cu v cp thot nc, thng gi, . Yu cu thit k v lp t cng trnh, phng tin v sinh, Yu cu ngun nc, nc (nu c),
V sinh b mt tip xc thc phm, Quy nh v sinh thit b ch bin, Yu cu ngn nga s nhim cho, Yu cu v sinh c nhn: trang phc bo h lao ng, ra tay, ..., Quy nh v yu cu, bo qun, s dng ho cht ty ra, Quy nh v kim tra sc kho cng nhn, Quy nh v kim sot ng vt gy hi, Quy nh v x l cht thi, Quy nh v v sinh vt liu bao gi ...., Cc hng dn cng vic v h thng cc biu mu/phiu (i km th tc/quy trnh/hng dn). Cc quy nh ca php lut, Cc yu cu, phn hi ca khch hng, Cc thng tin khoa hc mi,
8

b) Cc SSOP:

c) Cc ti liu khc: -

Kt qu nghin cu/th nghim mu, Quy nh v thit lp ti liu, lu h s ,

9. Ti liu tham kho

Quyt nh 05/1997/TC Hng dn chung v nhng ni dung c bn ca GMP p dng trong cc c s sn xut thc phm, TNG CC TIU CHUN O LNG CHT LNG, 1997. Quyt nh s 3886/2004/Q-BYT Trin khai p dng nguyn tc, tiu chun Thc hnh tt sn xut thuc (tn dc) theo khuyn co ca T chc Y t Th gii, B Y T, 2004. Quyt nh s 08/2004/Q-BNN-TY Quy nh trin khai p dng cc nguyn tc, tiu chun Thc hnh tt sn xut thuc th y (GMP), B NNG NGHIP V PTNT, 2004.

www.nafiqad.gov.vn http://www.fda.gov