Chng 6: chng trnh GMP

1. nh ngha: GMP l ba ch ci ca ba t ting Anh: Good Manufacturing Practices, ngha l thc hnh sn xut tt. + GMP l quy phm sn xut, tc l cc bin php, thao tc thc hnh cn tun th nguyn tc m bo sn xut ra nhng sn phm t yu cu cht lng v sinh an ton. + Quy phm sn xut thng tp trung vo cc thao tc, vn hnh trong cng ngh v thit b, thng c xy dng cho tng sn phm hoc nhm sn phm tng t, bao gm cc GMP ca tng cng on hoc mt phn cng on sn xut trong quy trnh cng ngh ch bin thc phm. 2. Phm vi kim sot ca GMP: + GMP gip kim sot tt c nhng yu t lin quan n CLVSATTP ca sn phm trong qu trnh sn xut ch bin, t khu tip nhn nguyn liu n thnh phm cui cng. (xem s hnh 8)
Ho cht Ph gia Nc Nc

Nguy n liu

Tay ngh

Thi gian

Nhit

Thnh phm

Mi trng

Hnh 8. Phm vi kim sot ca GMP + Phm vi c th ca GMP c th chia ra: - Phn cng: L cc iu kin sn xut nh: Yu cu v thit k v xy dng nh xng. Yu cu v thit k, lp t thit b, dng c ch bin. Yu cu v thit k v xy dng cc phng tin v cng trnh v sinh. Yu cu v cp, thot nc. -Phn mm: Bao gm cc quy nh v cng ngh, vn hnh sau y: Yu cu k thut ca tng cng on ch bin. Quy trnh ch bin. Quy trnh vn hnh thit b. Quy trnh pha ch, phi trn thnh phn.

Quy trnh ly mu, phn tch. Cc phng php th nghim. Quy trnh hin chun thit b, dng c o lng. Quy trnh kim sot nguyn liu, thnh phn. Quy trnh thng tin sn phm, ghi nhn. Quy trnh thu hi sn phm. 3. Ni dung v hnh thc Quy phm sn xut GMP: 3.1. Ni dung Quy phm sn xut: Mi GMP bao gm t nht cc ni dung sau: 1) M t r yu cu k thut hoc quy trnh ch bin ti cng on hoc mt phn cng on sn xut ; 2) Nu r l do phi thc hin cc yu cu hoc quy trnh k thut nu; 3) 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 k thut v kh thi; 4) Phn cng c th vic thc hin v biu mu gim st vic thc hin GMP. 3.2. Hnh thc mt quy phm sn xut: Quy phm sn xut c th hin di dng vn bn bao gm: Cc thng tin v hnh chnh (tn, a ch cng ty, tn mt hng hoc nhm mt hng, s v tn quy phm, ngy v ch k ph duyt ca ngi c thm quyn) v 4 ni dung chnh ca Quy phm sn xut. (Quy trnh; gii thch/l do; cc th tc cn tun th v phn cng trch nhim v biu mu gim st) 4.
(Tn, a ch cng ty) Quy phm sn xut - GMP (Tn sn phm) (GMP s: ) (Tn Quy phm: ) 1. Quy trnh (Processing) 2. GIi thch /l do (Explaining) 3. Cc th tc cn tun th (procedure) 4. PHn cng trch nhim v biu mu gim st (Responsibility and supervise) Ngy thng nm (Ngi ph duyt)

Phng php xy dng quy phm sn xut GMP: 4.1. Ti liu lm cn c xy dng GMP: 1) Cc lut l, quy nh hin hnh. 2) Cc tiu chun, quy phm k thut. 3) Cc yu cu k thut ca khch hng. 4) Cc thng tin khoa hc mi.

5) Phn hi ca khch hng. 6) Kinh nghim thc tin. 7) Kt qu thc nghim 4.2. GMP v chng trnh GMP: + Mi GMP l 1 Quy phm cho mt cng on sn xut v c th xy dng mt Quy phm cho nhiu cng on tng t. + Chng trnh GMP c xy dng da trn quy trnh sn xut ca tng mt hng c th hoc nhm mt hng tng t, t khu tip nhn nguyn liu n thnh phm cui cng. + Chng trnh GMP ca mt mt hng l tp hp ca nhiu Quy phm. V d: Hnh 9: Quy trnh ch bin v tn cc Quy phm sn xut (GMP) ca mt hng: Ph n lin
1. Nguyn liu (Bt m, nc, mui, phm mu TP) GMP.1.1

2. Nho trn

GMP.1.2

3. Cn mng, ct thnh si ph

GMP.1.3

4. Hp

GMP.1.4

5. Ct on

GMP.1.5

6. Chin

GMP.1.6

GMP.1.9

7. Lm ngui

GMP.1.7

8. Kim tra, chnh ph 9. Hn hp gia v (mui, m chnh, ti, t, ht tiu, hng liu)

GMP.1.8

10. Ch gia v

GMP.1.10

11. Giy OPP

12. ng gi

GMP.1.12

GMP.1.11

13. Nhp kho

GMP.1.13

4.3. Phng php xy dng Quy phm sn xut GMP:

4.3.1. tng cng on (hoc mt phn cng on) tin hnh: Nhn din cc yu t c th nh hng n cht lng sn phm v ra cc th tc hot ng kim sot c cc yu t ny. V d:
Nc ch bin Dng c ch bin Nhit bn thnh phm ch s dng nc sch ch s dng cc dng c sch p

4.3.2. Cc th tc nu trong Quy phm phi nhm t c nhng mc tiu hoc thng s ra trong quy trnh sn xut ch bin. 4.3.3. Cc th tc trong Quy phm cn c ra theo ng trnh t trong sn xut 4.3.4. Mi mt cng on xy dng mt Quy phm (mt GMP). Ton b cc cng on tp hp thnh: "Bng tng hp xy dng Quy phm sn xut (GMP)" Bng tng hp xy dng Quy phm theo mu sau:
Cng on Cc thng s, yu cu trong quy trnh Cc yu t nh hng n CLVSATTP Cc th tc cn tun th Gim st v biu mu gim st

5. Biu mu gim st v t chc thc hin: 5.1. Thit lp biu mu gim st: + Hiu qu gim st ph thuc vo: - Biu mu gim st - Phn cng gim st + Yu cu i vi biu mu gim st: - Tn v a ch x nghip - Tn biu mu - Tn sn phm - Ngy sn xut - Ngi gim st - Mc yu cu ca cc thng s cn gim st - Tn sut gim st - Cc thng s cn gim st - Ngy v ngi thm tra C th kt hp gim st nhiu cng on trn 1 biu mu 5.2. T chc thc hin: + Tp hp cc ti liu cn thit:

+ Thit lp chng trnh: Thit lp s quy trnh Thuyt minh quy trnh Son tho cc quy phm K hoch ly mu thm tra trn dy truyn Thit lp cc biu mu gim st + Thm tra li chng trnh + Ph duyt cho p dng + o to + Phn cng thc hin + Gim st vic thc hin + Lu tr h s V d:
X nghip ch bin thu sn Kim Hng Huyn X, Tnh Y

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Quy phm sn xut (GMP)

Tn sn phm: Tm bin luc bc v ng IQF GMP 1.5: Cng on ra 2

I. Quy trnh:

Sn phm sau khi phn c c ra 3 ln: ln th nht trong nc sch, ln th 2 trong nc sch c pha chlorine nng 10 ppm v c ra li ln th 3 trong nc sch. Nhit nc ra < 5oC. Tm sau khi ra c ro 5 pht trc khi c chuyn sang cng on luc.
2. Gii thch /L do:

Sn phm c ra trc khi gia nhit nhm gim bt lng vi sinh vt trn b mt v loi b tp cht cn ln trong sn phm.
3. Cc th tc cn tun th:

- Ch s dng nc sch ra sn phm - Ch s dng dng c c lm v sinh sch s - Cng nhn phi v sinh sch s trc khi tip xc vi sn phm - Chun b 3 thng nc: mi thng 100 lt nc sch, lm lnh bng vy n nhit < 5oC. Thng th 2 pha chlorine nng 10 ppm. - Mi ln ra khng qu 3 kg sn phm trong r nha ln lt qua 3 thng nc - Khuy o nh tm v gt cc tp cht ra ngoi - Thi gian ra mi r khng qu 2 pht. - Thm sau khi ra khong 5 r. - Thay nc sau khi ra ti a 10 r. - Sau khi ra, cc r tm c ro t nht 5 pht trn gi trc khi chuyn sang cp ng. - Khng cc r tm chng ln nhau.
4. Phn cng trch nhim v biu mu gim st:

- Qun c chu trch nhim t chc thc hin quy phm ny. - Cng nhn cng on ra 2 c trch nhim lm ng quy phm ny.

- QC ph trch cc cng on ch bin chu trch nhim gim st vic thc hin quy phm ny: kim tra nhit nc ra v nng chlorine trc mi ln chun b nc ra, kim tra cc thng s khc nhau sau mi 30 pht. - Kt qu gim st c ghi vo bo co gim st cc cng on ch bin (ra 1, bc v, phn c, ra 2). Ngy 13 thng 1 nm 2004 (ngi ph duyt)
Gim c

Kim Hng * * *