ASEAN GMP TEAM FRANCE BENCHMARKING 23 - 29 October 2005

ASEAN GMP TEAM FRANCE BENCHMARKING 23 - 29 October 2005

Project co-financed by European Union Project cofinanced by Asean ASEAN GMP TRAINING MODULE KIM TRA CHT LNG Prepared by : Stephanie Wong Choong Moy ~ Malaysia Eusebia Regodon ~ Philippines Approved by ASEAN GMP Team Endorsed by ASEAN Cosmetic Committee European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 1 Project co-financed by European Union NI DUNG TRNH BY Project cofinanced

by Asean Gii thiu Mc tiu Phm vi Nguyn tc kim tra cht lng Khi qut v kim sot cht lng m bo cht lng so vi kim tra cht lng Nguyn tc chung Yu cu c bn i vi vic kim tra cht lng n v kim tra cht lng Phng th nghim kim tra cht lng Trch nhim Ti liu kim tra cht lng Cng vic kim tra cht lng Tham kho European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 2 Project co-financed by European Union Project cofinanced by Asean

GII THIU European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 3 Project co-financed by European Union HNG DN Project cofinanced by Asean Thc hnh sn xut tt (GMP) l mt phn trong m bo cht lng rng m bo cc sn phm c sn xut v kim tra mt cch nht qun v ng tin cy. S nht qun v vic sn xut v kim tra ny rt cn thit. iu ny ch c c nh vo nhng m t r rng cch thc m theo cng vic s c thc hin. GMP c bit ch r cc ri ro tp nhim cho v ln ln m khng th kim tra y bng cch th nghim trn thnh phm. Nhng ri ro ny c th c kim sot tt nht bng mt h thng qun l cng vic thch hp. iu ny c ngha l h thng kim tra cht lng nn thit k sao

cho c th thy c cc ri ro ny v c th tm ra c bt k li no c th pht sinh. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 4 Project co-financed by European Union MC TIU Hiu c cc yu t chnh trong h thng kim sot cht lng. Hiu c cc yu cu c th v t chc, phng php, qui trnh v ngun lc. European Committee for Standardization Implementing Module 7

GMP Workshop Kuala Lumpur 1416 Nov 2005 Project cofinanced by Asean 5 Project co-financed by European Union PHM VI Kim sot cht lng lin quan n vic ly mu, thanh tra v th nghim cc nguyn vt liu ban u, sn phm trn dy chuyn, sn phm trung gian, sn phm ch ng gi v thnh phm. Nu c th, n bao gm, chng trnh kim tra mi trng, xem xt li h s l sn xut, chng trnh lu mu, cc nghin cu v s n nh v duy tr cc tiu chun k thut ng ca nguyn vt liu v thnh phm. European Committee for Standardization Implementing

Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 Project cofinanced by Asean 6 Project co-financed by European Union NGUYN TC KIM SOT CHT LNG European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 Project cofinanced by Asean 7 Project co-financed by European Union KHI QUT VIC KIM TRA CHT LNG Project cofinanced

by Asean S m bo m bo Mc ch s dng mong munc tiu Sn phm vi cht lng nht qun cho mc ch s dng mong munm vi cht lng nht qun cho mc ch s dng mong munc ch s dng mong mun dc ch s dng mong munng mong mun Thit lp cc yu cu v h thng cht lng Cch lm Sn phm lm bng nguyn vt liu tt, c cht lng v s lng c sn xut di iu kin thch hp theo SOP Ly mu iu tra v th nghim : Nguyn vt liu ban u, bn thnh phm v thnh phm Key Focus Area Chng trnh kim tra mi trng Chng trnh lu mu Xem xt ti liu ghi chp l Nghin cu s n nh S kim tra X l thuc th Tung/ Loi b : Kim sot cch b tr sn phm v cht liu

Ti ch European Committee for Standardization Implementing Kim tra tnh Module 7 nng k thut GMP Workshop Kuala Lumpur 1416 Nov 2005 Tr v 8 Project co-financed by European Union M BO CHT LNG SO VI KIM SOT CHT LNG Project cofinanced by Asean Thut ng m bo cht lng v kim tra cht lng thng c s dng hon i cho nhau ch nhng hnh ng m bo cht lng ca sn phm, dch v hay qui trnh C hai thut ng, tuy nhin cng c nhiu cch din gii bi v c nhiu nh ngha cho t m bo v kim sot V d nh nh ngha bn di, nhm mc ch ch ra s khc bit c trng gia 2 thut ng ny :

Assurance = The act of giving m bo: l hnh ng em li s tin confidence, the state of being certain, tng, s chc chn, hoc hnh ng or the act of making certain. lm cho chc chn Kim sot : L cng vic nh gi a ra cu tr li thch hp, l vic hng dn hay trnh by v s thay i ca mt qu trnh l do mt h thng bt bin ca cc nguyn nhn thay i. European Committee for Standardization Implementing m bo cht lng : Tt c cc hot ng c h thng, c k hoch c thc hin trong h thng cht lng c th chng t l cung cp s tin tng v mt sn phm hoc dch v t c cc yu cu v cht lng. Kim sot cht lng : l k thut v cng vic m bo cc yu cu v cht lng Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 9

Project co-financed by European Union NGUYN TC CHUNG Project cofinanced by Asean Mi doanh nghip sn xut hp php xut cn c mt b phn kim sot cht lng. S c lp vi b phn sn xut v cc phng ban khc c xem l iu c bn phi lm. Di quyn iu hnh ca ngi c kinh nghim v c kh nng thch hp cng vi mt hoc mt vi phng th nghim kim tra m ngi c th tu nghi s dng. Nu khng c iu kin, c th nh cc phng th nghim ng tin cy bn ngoi. European Committee for Standardization Implementing

Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 10 Project co-financed by European Union Project cofinanced by Asean CC YU CU C BN I VI VIC KIM TRA CHT LNG European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 11 Project co-financed by European Union CC YU CU C BN Project cofinanced by Asean

B phn kim tra cht lng nn c : Cc ngun l m boc: phng tin Nhn s c nng lc C cc phng php bng vn bn c duyt Nhim vc ch s dng mong mun : Ly mu, thanh tra, th nghim Xut kho hoc loi b. Gim st i tng kim tra: Nguyn vt liu ban u, sn phm trung gian, sn phm ch ng gi v thnh phm Cc sn phm b tr li; Module 7 GMP Workshop Kuala Lumpur 14 Cc iu kin thuc mi trng. 16 Novv 2005 European Committee for Standardization Implementing 12 Project co-financed by European Union

Project cofinanced by Asean PHNG KIM TRA CHT LNG C phng kim tra cht lng ring cho mi n v sn xut. Phng th nghim phi c kh nng thc hin tt c cc th nghim theo cc tiu chun c duyt, hoc thc hin c cc phn chnh, v cc phn ph th giao cho cc phng th nghim hp ng c duyt. Phng th nghim kim tra cht lng phi c tch bit khi khu vc sn xut, c bit l i vi phng th nghim vi sinh. Cc phng th nghim nn c thit k ph hp vi cc hot ng cn c thc hin . Phi c khng gian trnh ln ln v tp nhim cho. Phi c ch cc sn phm mu v cc bo co. Cc phng ring bit i khi cn thit bo v cc dng c nhy cm khi chn ng, nhim in, m t, vv European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 13 Project co-financed

by European Union Project cofinanced by Asean B PHN KIM SOT CHT LNG Cng ty ln : B phn kim sot cht lng. Cng ty nh : C cc nhim v c th vi mt s dng c th nghim gii hn, hoc Phn tch theo hp ng k kt vi cc phng th nghim bn ngoi Trch nhim c xc nh trong cc phng php bng vn bn c lp vi b phn sn xut v cc phng khc l iu c bn Di quyn ca mt chuyn gia c kh nng v kinh nghim thch hp European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 14 Project co-financed by European Union TRCH NHIM

Project cofinanced by Asean Kim tra, chp thun hay loi b cc nguyn vt liu nhp vo, bn thnh phm, thnh phm, v cc sn phm b tr v. Phi kim tra trong sut qu trnh sn xut (kim sot qu trnh) Thit lp, tiu chun ho, v thc hin tt c cc th tc kim tra cht lng, cng nh xy dng cc tiu chun k thut ca mi nguyn vt liu. Cng vi trng b phn sn xut xy dng cc tiu chun k thut ca sn phm trung gian, sn phm ch ng gi v thnh phm. Duyt cc hng dn v x l li v cc hng dn ti ch Xem xt li tt c cc bo co sn xut tm ra li v m bo thc hin cc cuc iu tra v c bin php khc phc. Tham gia vo tt c cc quyt nh c lin quan n cht lng sn phm. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 15 Project co-financed by European Union

CC TRCH NHIM KHC Project cofinanced by Asean Thit lp, thm tra v thc hin tt cc cc th tc kim tra cht lng. nh ga, duy tr, bo qun, v gim st tt c cc tiu chun dng tham kho v cc mu lu. Xem xt li h s l sn xut. Duy tr tiu chun k thut ph hp cho nguyn vt liu v thnh phm. Kim tra s n nh ca mi thnh phm. Tham gia vo : iu tra cc khiu ni sn phm Gim st mi trng Hun luyn GMP. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005

16 Project co-financed by European Union Project cofinanced by Asean CC TI LIU KIM TRA CHT LNG European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 17 Project co-financed by European Union Project cofinanced by Asean KIM TRA TIU CHUN K THUT Mi tiu chun k thut phi c duyt, k v ghi ngy thng, v phi c lu gi bi b phn kim tra cht lng.

Cc tiu chun k thut sau ti thiu nn c duy tr v kim sot : Tiu chun k thut ca nguyn vt liu ban u Tiu chun k thut v qu trnh x l nc. Sn phm trung gian v sn phm ch ng gi, nu c th Tiu chun k thut ca thnh phm. Cng thc gc Bo co l sn xut. Module(BMR) 7 European Committee for Standardization Implementing GMP Workshop Kuala Lumpur 1416 Nov 2005 18 TIU CHUN K THUT CA NGUYN VT LIU BAN U Project co-financed by European Union

Cc chi tit sau y cn c trong tiu chun k thut : Tn c ch nh, v m tham chiu ni b nu c th. Cc yu cu v cht lng v s lng vi gii hn cho php. Da vo thc t ca cng ty, cc yu cu khc c th c thm vo tiu chun k thut: Nh cung cp v nh sn xut ban u Hng dn ly mu v kim tra, v vic tham chiu n mt phng php c duyt. iu kin bo qun hoc ch Thi k bo qun ti a trc khi kim tra li European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 Project cofinanced by Asean 19 Project co-financed by European Union

TIU CHUN K THUT CA NC C X L Project cofinanced by Asean Tiu chun nc ung c xc nh nh l tiu chun ti thiu cho vic s dng trong qu trnh sn xut m phm. Cc tiu chun k thut v cht lng ho hc v vi sinh thch hp cn c thit lp da trn im s dng. Cn thc hin kim tra nh k, v d hng tun S x l thm c th cn thit da trn cng thc sn phm, quy trnh v cc yu cu i hi. Cc yu cu k thut ca nc vi s x l thm s c xy dng da trn cc tiu chun k thut xy dng bi nh cung cp hoc tiu chun v thuc. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 Microsoft PowerPoint Presentation 20 Project co-financed

by European Union Project cofinanced by Asean TIU CHUN K THUT CA THNH PHM Cc tiu chun k thut ca thnh phm cn bao gm : Tn ngi c b nhim, m tham kho ni b nu c th. S cng thc M t v thnh phm v chi tit ng gi. Cc yu cu v s lng v cht lng vi mc gii hn cho php Hng dn th nghim v ly mu hoc tham chiu n mt phng php c duyt. iu kin bo qun hoc ch , nu c th. Tui th ca sn phm, nu c. Yu cu ghi s l (bao gm ngy sn xut v ngy ht hn) European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 21 Project co-financed by European Union

KIM SOT QU TRNH Project cofinanced by Asean Vic thanh tra hoc th nghim da trn vic gim st quy trnh hoc th nghim sn phm mu thc t trong mt khu vc hoc gia cc khong thi gian xc nh. S c lu thnh ti liu trong H s l sn xut (BMR). Kt qu s phi ph hp vi cc yu cu v H s l sn xut/ng gi Biu kim tra/ cc cng c thng k khc i vi kh nng x l c s dng theo xu hng phn tch. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 22 Project co-financed by European Union TI LIU TH NGHIM KHC

Project cofinanced by Asean Ti liu th nghim khc bao gm Phng php ly mu Bo tr v hiu chun thit b Phng php kim tra tnh n nh, nu c th Gim st mi trng, nu c th Cc phng php v bo co th nghim (bao gm cc bng nhp v/hoc nht k th nghim) Bo co phn tch v/hoc cc chng th European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 23 Project co-financed by European Union LU GI H S CHT LNG Project cofinanced by Asean Cng thc gc v cc s liu sn xut l nn c gi trong sut tui th ca sn phm + 1 nm.

Cc bo co th nghim khc (nh kt qu kim tra phn tch, kim tra mi trng) th c ngh l gi theo cch m c th nh gi c xu hng Cc d liu khc nh s nht k th nghim v/ hoc cc bo co c gi tnh trng sn sng c th s dng. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 24 Project co-financed by European Union Project cofinanced by Asean CC CNG VIC KIM TRA CHT LNG European Committee for Standardization Implementing Module 7

GMP Workshop Kuala Lumpur 1416 Nov 2005 25 Project co-financed by European Union Project cofinanced by Asean QUY TRNH KIM TRA CHT LNG Bt u Nguyn vt liu u vo Nc Sn phm vi cht lng nht qun cho mc ch s dng mong munm b tr li ghi chp li QC/QA Status Kimdch dch Kim Quarantine Quarantine 2. Nhn Sn phm vi cht lng nht qun cho mc ch s dng mong munm d dang Sn phm vi cht lng nht qun cho mc ch s dng mong munm chnh Thnh phm vi cht lng nht qun cho mc ch s dng mong munm Kim tra mi trng

3. Ly mu u 4. kim tra mu u 5. Xem li ghi chp li ghi chp l Bo co Th nghim Xutkho kho Xut Yu cu k thut Trv v Tr NO YES Xutkho kho Xut 6. Tung hng Kt thc European Committee for Standardization

Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 7. Khng ph hp hay khng t tiu chun 8. Loi b hng Loib b Loi Kt thc 26 Project co-financed by European Union TIP NHN Project cofinanced by Asean Phi c phng php bng vn bn v vic tip nhn, dn nhn ni b, bit tr v bo qun nguyn vt liu ban u, nguyn liu ng gi v cc nguyn liu khc khi thch hp. Da trn vic tip nhn hng ho c cung cp, nhn dng ca n, tnh r rng ca s l, tnh trng nguyn vn ca bao b v du nim phong

phi c xc nh trc khi tip nhn. Nh cung cp phi cung cp chng ch phn tch cng vi vic tip nhn nguyn vt liu ban u. Nhng hng ho bit tr phi c cch ly ra khi nhng l hng c duyt xut. Hng ho b tr li phi c gi mt ni xc nh m li vo cn phi c kim sot (nh ni c th kho li) European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 27 Project co-financed by European Union LY MU Project cofinanced by Asean Vic ly mu phi c thc hin theo nhng phng php bng vn bn m t di y :

Phng php ly mu Dng c dng ly mu S lng mu cn ly Loi v iu kin ca thng ng mu (v d: chai thu tinh mu h phch) Xc nh cc thng hng c ly mu Lu c bit cho cc nguyn vt liu nguy him iu kin bo qun (nu c th) Hng dn lm sch v bo qun dng c ly mu Hng dn vic nim phong li cc thng hng b m ra. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 28 Project co-financed by European Union QUI TRNH LY MU

Project cofinanced by Asean Dc ch s dng mong munng cc ch s dng mong mun ly mu u nh dao, km, ca, ba, cha vn ai c, phng tin loi bi (tt nht l my ht bi) Cht liu ng li kin hng (nh dy rng), cng nh cc nhn dnh ch ra nhng th bn trong c ly ra khi kin hng hay thng hng. Cc thng hng c ly mu nn c lau chi trc khi ly mu nu cn. Cn c phng php c th bng vn bn m t hot ng ly mu. Phng php ny nn bao gm nhng yu t v an ton v sc kho trong khi ly mu. Thng hng c dng lu tr mu phi khng tng tc vi cc cht liu ly mu cng nh khng c s nhim khun. Nn bo v cc mu trnh nh sng, khng kh, hi m, vv.. theo yu cu cc hng dn lu tr mu nguyn vt liu c ly. Dng c dng ly mu vi sinh phi c ty trng trc khi s dng. K thut v trng nn c s dng trong sut qu trnh ly mu. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 29

Project co-financed by European Union Project cofinanced by Asean K HOCH LY MU 1. Nguyn vt liu Vic ly mu cho nguyn vt liu nn da trn tiu chun ly mu c sn, v d : k hoch n da trn cng thc n=1+N, trong N l s lng mu ang k gi; k hoch p da trn cng thc p = 0.4 N, trong N l s sn phm ly mu; hoc k hoch rn theo cng thc r = 1.5N . Gim k hoch ly mu, v d p plan ch c xem xt khi c mt s bo m v tnh ng nht ca cht liu 2. Nguyn liu ng gi v thnh phm K hoch ly mu i vi nguyn liu ng gi da trn tiu chun ly mu c xc nh, v d tiu chun Anh BS 6001-1, ISO 2859 hoc ANSI/ASQCZ1.4-1993. European Committee for Standardization Implementing

Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 Microsoft Word Document 30 Project co-financed by European Union DNG C LY MU Project cofinanced by Asean Xng dng cho cht cng ng nhn cho cht lng Xin dng cho ti Bnh cha dng cho bn cha ln European Committee for Standardization Implementing

Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 31 Project co-financed by European Union TH NGHIM & PHN TCH Project cofinanced by Asean Tt c cc th nghim phi c thc hin theo phng php c nu ra trong tiu chun k thut. Vic gim t l th nghim phi c lu vo h s. Vic th nghim c th c thc hin bi phng th nghim ca nh sn xut hoc phng th nghim bn ngoi. Khi th nghim c thc hin ti cng ty, phng th nghim phi sn sng. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005

32 Project co-financed by European Union Project cofinanced by Asean D LIU PHNG TH NGHIM (1) B phn Kim tra cht lng cn duy tr cc bo co phn thch lin quan n vic kim tra nguyn vt liu v sn phm. Cc bo co cn bao gm cc ni dung sau : Kt qu ca mi ln th nghim, bao gm s quan st v tnh ton, lin quan n cc tiu chun k thut c xy dng (cc tnh ton c thc hin trn giy nhp phi c bao gm trong bo co) Ngun gc ca tiu chun k thut c s dng. Ch k ca ngi thc hin phng php kim tra cht lng. Xem xt ln cui (v d: ban lnh o phng th nghim), quyt nh a ra v ngy xc nhn bi chuyn gia c u quyn (ngi gim st/ngi qun l) European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005

33 Project co-financed by European Union Project cofinanced by Asean D LIU PHNGTH NGHIM (2) D liu phng th nghim phi c lu h s theo cch bo m tnh chnh xc, tnh xc thc v tnh y , duy tr c tnh ton vn v bo m kh nng truy nguyn. D liu ghi chp phi r rng, thng xuyn (khng ghi bng bt ch) c kh nng truy li n cc ch tiu c kim tra. H s vit bng tay hay bng my ni chung, phi c xem xt li, k v ghi ngy thng. C chnh sch bng vn bn v vic ly s trung bnh, gch xo nhng ch sai, nhng biu quan trng, x b cc trang nht l th nghim, hoc cch in vo ch trng, vv. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 34

Project co-financed by European Union MU LU (1) Project cofinanced by Asean Mu lu phi i din cho l nguyn vt liu hoc sn phm m chng c ly. Mu lu phi c s lng cho php t nht 2 ln kim tra li. Cc mu lu cho mi l thnh phm phi c gi trong mt thi k xc nh Thnh phm cn c gi trong bao b cui cng v c bo qun trong iu kin c ngh (v d, ngi tiu dng s dng sn phm nhit phng) European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 35 Project co-financed by European Union

MU LU (2) Project cofinanced by Asean D liu v mu lu phi c lu gi cng vi thng tin v mu, s l v ni bo qun gip d dng truy nguyn. Trc khi hu b cc mu lu, phi thc hin kim tra cm quan. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 36 Project co-financed by European Union Project cofinanced by Asean KIM TRA VIC CHP NHN NGUYN VT LIU BAN U 1. Tt c cc nguyn vt liu ban u phi c

thm tra trc khi s dng 2. Vic thm tra cn bao gm : Xem xt Kt qu th nghim ca nh sn sut so vi cc tiu chun k thut c xt duyt. Nhng th nghim khc c thc hin khi thch hp : Kim tra nhn dng/ nhn dng bao b v cc tnh cht khc ca nguyn liu phi c kim tra. Bao b trc tip vi sn phm: khng b lng rch hay c ch b bc ra, du nim phong cn nguyn. Nhn d c, c s l Tn sut: mi l trong cc l ca nh sn xut. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 37 Project co-financed by European Union KIM TRA VIC CHP NHN NC X L Project cofinanced

by Asean Ti thiu phi t c tiu chun nc ung ca WHO hoc tiu chun quc gia. Tiu chun k thut ca nc c x l phi da vo c tnh c thit k ca nh cung cp hoc tiu chun ca sch hng dn y t. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 38 Project co-financed by European Union KIM TRA VIC CHP NHN Project cofinanced by Asean SN PHM CH NG GI TRN DY CHUYN Vic th nghim v thanh tra sn phm trong qu trinh sn xut c thc hin bng cch gim st qui trnh hoc phn tch mu thc t

mt v tr v thi im c xc nh. Kt qu phi m bo theo ng cc thng s qui trnh c thit lp hoc cc dung sai c th chp nhn c. Dn dp v sinh dy chuyn phi c thc hin trn tt c cc dy chuyn ng gi. Khi cn thit, tiu chun tham kho v ghi nhn v cc yu cu v ghi m s phi c sn. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 39 Project co-financed by European Union KIM TRA VIC CHP NHN Project cofinanced by Asean THNH PHM Xem xt li h s l sn xut Xem xt tt c nhng im khng ph hp hoc lch c lu trn h s l sn xut v hng dn sn xut hoc ti ch li.

Xem xt li cc kt qu vt l, ho cht v vi sinh Xem xt li cc mu t cc l thm tra s khng ph hp ca n vi yu cu ca BMR Xt duyt kt qu phn tch vi kt lun r rng v tnh trng sn phm, nh xut kho hay loi b European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 40 Project co-financed by European Union Project cofinanced by Asean IU TRA V MU KHNG T TIU CHUN K THUT Cn c sn phng php bng vn bn. Mt cuc iu tra tiu biu bao gm : Xem xt vic tnh ton m bo chng chnh xc. Xem xt cc phng php th nghim c dng. Xem xt cc thit b, ct, biu v cc phn tch trc y ca cc mu ca cc sn phm/nguyn liu ging nhau. Xem li cc thuc th/ s tiu chun ho c thc

hin cho vic th nghim (nh ng ht). Mt cuc iu tra v nh gi y cc kt qu ban u trc khi lm th nghim li. Xem xt li lai lch sn phm/ nguyn liu Phn cng mt ngi c trch nhim iu tra Lu li thnh ti liu i vi th nghim li hoc ly mu li. Ti liu thch hp ca cc cuc iu tra, ngh phi c trin khai. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 41 Project co-financed by European Union Project cofinanced by Asean THUC TH TRONG PHNG TH NGHIM Thuc th nn c pha ch theo nhng phng php bng vn bn. Dung dch chun, ngy tiu chun ho gn nht v h s hiu chnh gn nht cn phi ghi r. Khi cn thit nn ghi ngy nhn thuc th trn bao b.

Nn tun th cc hng dn s dng v bo qun. Khi cn, th nghim nhn dng v/hoc cc th nghim khc v thuc th phi c thc hin khi tip nhn hoc trc khi s dng. Thuc th phi c chng nhn bi nh sn xut ban u v cht lng ca loi thuc th c mua, phi c chng nhn cp quyn xem xt v lm r khi chp nhn. Phi c s tay an ton trong phng th nghim m bo hot ng an ton vi thuc th v ho cht. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 42 Project co-financed by European Union Project cofinanced by Asean THUC TH TRONG PHNG TH NGHIM Tt c cc thuc th dng mong mun nn dn nhn bao gm cc thng tin sau : Tn thuc th Nng hoc m c

Ngy ht hn Ngy pha ch Tn ca ngi pha ch Bng d liu an ton nguyn liu European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 43 Project co-financed by European Union GIM ST MI TRNG (1) Project cofinanced by Asean Gim st mi trng c thc hin khi c th Mc tiu l chng minh rng mi trng sn xut ang mc kim sot vi sinh thch hp cho mi sn phm/ mi nhm sn phm c th. S la chn a im ly mu da trn : Thit k/ kch thc phng Qu trnh sn xut Tnh nhy cm ca sn phm Nhng a im ly mu c th bao gm

Phng/ khu vc ly mu nguyn vt liu ban u Khu vc phn phi Khu vc sn xut Phng th nghim vi sinh European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 44 Project co-financed by European Union GIM ST MI TRNG (2) Project cofinanced by Asean Gii hn Cnh bo v Hnh ng cn c xy dng da theo phng php thng k. S la chn mi trng dng cho pht hin v tng trng ca cc vi sinh gy tp nhim khng kh phi c xy dng. Tn sut ly mu phi c xy dng, v d hng tun. Phng php trc tip v gin tip phi sn sng, thng c s dng nht l dng c ly

mu khng kh STA, SAS v a c chun b sn. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 45 Project co-financed by European Union NGHIN CU N NH (1) Project cofinanced by Asean Th nghim n nh ch c thc hin khi cn Thi gian n nh thc t phi ko di n ht tui th ca cc sn phm mi v phi bao gm cc thng s sau : S lng l i cho cc c l khc nhau Phng php kim tra l tnh, ho tnh, vi sinh c lin quan Tiu chun chp nhn M t h thng ng kin hng Khong cch gia cc thi im kim tra M t iu kin bo qun

European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 46 Project co-financed by European Union NGHIN CU N NH (2) Project cofinanced by Asean S lng l v tn s ly mu phi cung cp d liu cho php vic phn tch xu hng. Trng hp xu nht phi c bao gm trong thi gian thc t ca chng trnh o n nh sau bt k s thay i hoc lch ng k ti qui trnh hay ng gi, v d: sau khi ti ch. Bng tng hp d liu phi c bin son, vi kt lun tm thi da trn xu hng phn tch. Kt qu nghin cu v n nh phi c xem xt bi nhng ngi c quyn. European Committee for Standardization

Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 47 Project co-financed by European Union HIU CHUN Project cofinanced by Asean Nhm duy tr tnh ng v chnh xc ca thit b th nghim vo mi thi im m bo s tin tng cao nht i vi cc phng php o lng c nh hng n quyt nh phn b nguyn vt liu, m vn khng ph v cc mc xch truy tm lai lch sn phm theo tiu chun quc gia. Xc nh xem thit b c cn ph hp vi mc ch d kin khng. Da trn vic so snh ca tiu chun ban u hoc dng c o lng c bit l chnh xc vi mt thit b khc (cn c hiu chnh) N c s dng tm ra, bo co, loi tr bng cch iu chnh bt k s sai bit no ca thit b c hiu chnh. European Committee for Standardization

Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 48 Project co-financed by European Union PHN LOI THIT B Project cofinanced by Asean Thit b quan trng : Thit b o lng trc tip nh hng n cht lng ca sn phm cui cng. Vic o lng cc thng s sn xut quan trng trong cc yu cu k thut ca qui trnh. Thit b khng quan trng : Thit b o lng khng trc tip khng nh hng n cht lng sn phm cui cng. Phi c bo tr theo lch bo tr ca cng ty. European Committee for

Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 49 Project co-financed by European Union Project cofinanced by Asean KHONG THI GIAN GIA 2 LN HIU CHUN Da vo: S phn loi quan trng hay khng quan trng Vic s dng (s dng nng hay nh) Vic vn hnh (nng hay nh) ngh ca nh sn xut Tham kho NIST hoc hng dn ca mt t chc chng nhn cho mt h thng o lng c th. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005

50 Project co-financed by European Union TIU CHUN BAN U Project cofinanced by Asean Trt t chnh xc cao nht trong h thng o lng C th truy li du vt theo tiu chun quc gia v quc t European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 51 Project co-financed by European Union Project cofinanced by Asean

TIU CHUN*/TI LIU THAM KHO Tiu chum vi cht lng nht qun cho mc ch s dng mong munn tham kho Phi c hiu chun bi mt t chc c th cung cp vic truy nguyn. Cc tiu chun o lng tham kho gi trong phng th nghim ch dng cho vic hiu chun. N s c hiu chun trc hoc sau bt k s iu chnh no. Ti liu tham kho Khi c th, s truy nguyn li cc n v o lng quc t, hoc cc Ti liu Tham kho c chng nhn. Ti liu Tham kho ni b s c kim tra n thc tin k thut v kinh t. European Committee for Standardization Implementing Note: Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 * Working Standards 52 Project co-financed by European Union KT QU HIU CHUN Project cofinanced by Asean

C th theo di theo tiu chun Quc gia hoc Quc t Tiu chun o lng c xc nh vi thi gian hiu lc Kt lun c lp da trn tnh hiu lc ca hiu chun Chng nhn phi c xt duyt li bi ngi c thm quyn European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 53 Project co-financed by European Union S THM TRA Project cofinanced by Asean p dng i vi cc thit b khng th hiu chun (sa cha, i chiu tng quan, vv) Vic thm tra tiu chun o lng vi h s hiu chnh phi c lu h s. Bo co thc t v kt qu phi bao gm h s

hiu chnh. H s hiu chnh nhit - 2 0C. Gi tr o: 240 C Gi tr bo co = 24 0 C 2 0 C= 22 0 C European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 54 Project co-financed by European Union Project cofinanced by Asean KHNG T YU CU HIU CHUN Loi b khng dng thit b na Vic kim tra OOC c thc hin xc nh nguyn nhn ca s sai lch. nh gi nh hng ca kt qu OOC i vi cht lng thnh phm v cc thng s o lng trc . Tt c nhng pht hin khi iu tra phi c lu trong h s. European

Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 55 Project co-financed by European Union BO CO HIU CHUN Project cofinanced by Asean K hoch hiu chun gc. Bao gm vic kim sot tt c cc thit b o lng quan trng cha cc chi tit sau : Tn Cch nhn dng bi s model v s seri V tr Ngi chu trch nhim Tn sut hiu chun Ngy n hn hiu chun Chng ch hiu chun Phng php hiu chun European Committee for Standardization Implementing

Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 56 Project co-financed by European Union CHNG CH HIU CHUN Project cofinanced by Asean Tn v a ch ca phng th nghim hiu chun theo hp ng Tn v a ch ca khch hng M t v nhn dng cc khon mc c hiu chun. iu kin mi trng khi thc hin hiu chun Ngy tip nhn dng c, ngy hiu chun v ngy hiu chun k tip. Phng php hiu chun Kt qu hiu chun Ch k v chc v ca ngi chu trch nhim hiu chun Hp ng hiu chun bn ngoi phi c cng nhn bi cc t chc nh nc. European Committee for

Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 57 Project co-financed by European Union NHN DNG HIU CHUN Project cofinanced by Asean Tnh trang hiu chun thit b phi sn sng v c gn/dn trn thit b nu c th. Nhn dng thit b phi c nhng thng tin sau : tn ca thit b s seri ngy c hiu chun tnh trng k hoch hiu chun ln k tip v ch k ca ngi thc hin hiu chun European Committee for Standardization Implementing

Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 58 Project co-financed by European Union TI CH (1) Project cofinanced by Asean Ti ch bao gm c nh ngha ca Reprocessing and Rework nh ngha Reprocessing: a ton b hoc mt phn l hng ca sn phm ch ng gi, sn phm trung gian hoc sn phm ca mt l ring l tr li cng on trc ca qui trnh sn xut/ng gi c xt duyt do khng t tiu chun k thut Rework: a ton b hoc mt phn l hng sn phm ch ng gi, sn phm trung gian hoc sn phm ca mt l ring l tr li qui trnh sn xut/ng gi k tip do khng t tiu chun k thut European Committee for Standardization Implementing

Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 59 Project co-financed by European Union TI CH (2) Project cofinanced by Asean Hon tt bo co khng t tiu chun (OOS)/khng ph hp vi nh gi v cc nguy c da theo phng php c duyt. Hng dn Ti ch bao gm cc chi tit sau: Thnh phn b sung, nu cn Hng dn ti ch Trch nhim K hoch ly mu Cc ch tiu chp nhn Hng dn Ti ch c duyt bi QC. Nu l hng c iu chnh theo yu cu kim tra trong qu trnh sn xut, n khng c xem nh hot ng ti ch. European Committee for Standardization Implementing Module 7

GMP Workshop Kuala Lumpur 1416 Nov 2005 60 Project co-financed by European Union KIM SOT SN PHM TI CH Project cofinanced by Asean t cc ch tiu chp nhn ca bng Hng dn Ti ch. Khi n nh ca sn phm b nghi ng, cn thc hin th nghim b sung bt k thnh phm no qua ti ch, nghin cu v n nh cng cn c thc hin. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 61 Project co-financed

by European Union SN PHM TR LI (1) Project cofinanced by Asean nh ngha- Thnh phm c phn phi v nay b thu hi v nhiu l do khng ch do nguyn nhn sn phm b khiu ni. Sn phm b tr li c nhn bit v gi li. Nu cc iu kin m sn phm c gi, bo qun, xp ln tu trc hoc trong qu trnh sn phm c tr v, hoc cc bao b cha sn phm, ghi nhn c du hiu nghi ng v an ton hay cht lng, sn phm tr v s phi c hu b tr khi cc kim tra, th nghim chng minh rng sn phm vn t cc yu cu v an ton, nhn bit v cht lng. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 62 Project co-financed by European Union

SN PHM TR LI (2) Project cofinanced by Asean Mt sn phm c th c x l li v sn phm sau khi x l phi t cc tiu chun, yu cu k thut v c im thch hp. H s v sn phm ti ch phi c lu gi v bao gm tn, s l (hay s kim sot hay s m), l do b tr li, s lng tr li, vv European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 63 Project co-financed by European Union SN PHM TR LI (3) Project cofinanced by Asean

Nu mt sn phm b thu hi c xc nh c lin quan n cc l sn phm, phi thc hin iu tra thch hp. Phng php i vi vic gi li, kim tra v ti ch sn phm b thu hi phi c ghi thnh vn bn v theo di. Vic hu b cc sn phm thu hi phi da trn cc phng php c duyt. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 64 Project co-financed by European Union Project cofinanced by Asean KIM TRA CC SN PHM B THU H Cc sn phm c bo qun trong cc iu kin khng thch hp bao gm vic nhit , m, khi , p sut hay bc x tng qu mc do cc thm ho t thin nhin, do chy, tai nn hay cc thit b khng hot ng s khng c tn dng v a ra th trng. Bt c lc no nu c s nghi ng rng mt sn phm c lin

quan n cc iu kin nh ni trn, th vic tn dng ch c th c thc hin khi t c cc ch tiu chp nhn sau y: Ghi nhn sn phm t theo yu cu qui nh Kt qu th nghim cho thy sn phm t cc tiu chun k thut Kt qu kim tra v cm quan trn sn phm v bao b c lin quan khng b nh hng v vn tng ng vi tiu chun. European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 65 Project co-financed by European Union Project cofinanced by Asean RELATED HYPERLINK DOCUMENTS

Trainer Manual of GMP ASEAN Quality Control ASEAN GMP Supplementary Module : Water ASEAN GMP Supplementary Module : Calibration WI of QC Working Procedure WI of Sampling of Incoming Raw Materials WI of Sampling of Incoming Packaging Materials WI of Handling Incoming Materials WI of Handling Finished Goods WI of Handling and Testing of Raw Materials WI of Stability Study WI of Environment Monitoring European Committee for Standardization Implementing Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 66 Project co-financed by European Union REFERENCES

1. Guideline on ASEAN Cosmetic GMP (2003) 2. U.S. Food Drug Administration, Center for Food Safety Applied Nutrition, Cosmetic Compliance program 3. NIST 4. WHO Guideline for Drinking Water Quality 5. EUDRALEX, Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice, ,Volume 4. 6. WHO, Good Manufacturing Practices: Starting Materials. 7. Ariffin F., Consultation to Discuss : Stability Studies in a Global Environment. 8. International Pharmacopoeia 9. WHO Guideline For Sampling OF Pharmaceuticals and related materials. 10. PDA Technical Report No. 13 revised, Fundamentals of Module 7 Program an Environmental Monitoring European Committee for Standardization Implementing GMP Workshop Kuala Lumpur 1416 Nov 2005 Project cofinanced by Asean 67 Project co-financed by European Union

European Committee for Standardization Implementing Project cofinanced by Asean Module 7 GMP Workshop Kuala Lumpur 1416 Nov 2005 68

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