B Y T

CNG HA X HI CH NGHA VIT NAM

c lp - T do - Hnh phc
S: 14/2012/TT-BYT

H Ni, ngy 31 thng 8 nm 2012

THNG T
Quy nh cc nguyn tc, tiu chun Thc hnh tt
sn xut bao b dc phm v hng dn trin khai, p dng

Cn c Lut Dc s 34/2005/QH11 ngy 14/6/2005;

Cn c Ngh nh s 188/2007/N-CP ngy 27/12/2007 ca Chnh ph quy
nh chc nng, nhim v, quyn hn v c cu t chc ca B Y t;
Cn c Quyt nh s 43/2007/Q-TTg ngy 29/3/2007 ca Th tng
Chnh ph v vic ph duyt n Pht trin cng nghip Dc v xy dng
m hnh h thng cung ng thuc ca Vit Nam giai on 2007 - 2015 v tm
nhn n nm 2020;
Xt ngh ca Cc trng Cc Qun l dc,
B Y t ban hnh Thng t quy nh cc nguyn tc, tiu chun Thc hnh
tt sn xut bao b dc phm v hng dn vic trin khai, p dng nh sau:
Mc I
QUY NH CHUNG
iu 1. Phm vi iu chnh
Thng t ny quy nh cc nguyn tc, tiu chun Thc hnh tt sn xut
bao b dc phm v hng dn vic trin khai, p dng cc nguyn tc, tiu
chun Thc hnh tt sn xut bao b dc phm trong lnh vc sn xut bao b
tip xc trc tip vi thuc.
iu 2. i tng p dng
Thng t ny quy nh p dng i vi cc c s sn xut, kinh doanh bao b
tip xc trc tip vi thuc v cc c s sn xut thuc lu thng trn th trng
Vit Nam.
Mc II
NGUYN TC TIU CHUN THC HNH TT SN XUT BAO
B DC PHM V HNG DN TRIN KHAI P DNG
iu 3. Nguyn tc tiu chun Thc hnh tt bao b dc phm
Cc nguyn tc, tiu chun Thc hnh tt sn xut bao b dc phm c
quy nh ti Ph lc 1 v Ph lc 2 nh km Thng t ny.
1

iu 4. T chc thc hin

1. Cc Qun l dc ch tr, phi hp vi cc n v lin quan t chc ph
bin cc nguyn tc, tiu chun Thc hnh tt sn xut bao b dc phm (sau
y gi tt l GMP bao b dc phm), danh mc kim tra GMP bao b dc
phm v hng dn trin khai, p dng GMP bao b dc phm cho S Y t cc
tnh, thnh ph trc thuc Trung ng, Y t cc ngnh v cc c s sn xut bao
b tip xc trc tip vi thuc.
2. Cc c s sn xut bao b tip xc trc tip vi thuc c nhu cu ng k
kim tra cp Giy chng nhn GMP bao b dc phm:
a) Nghin cu v hun luyn cc nguyn tc, tiu chun GMP bao b dc
phm v danh mc kim tra GMP bao b dc phm v cc quy nh c lin
quan cho cn b, nhn vin trong c s.
b) Cn c cc nguyn tc, tiu chun GMP bao b dc phm, quy m, ngun
lc v nh hng pht trin p dng ph hp vi thc t trin khai ti c s.
c) Da trn danh mc kim tra GMP bao b dc phm (Ph lc 3) xy
dng danh mc t kim tra ca c s mnh v tin hnh t kim tra pht hin
cc khim khuyt v khc phc cc tn ti.
iu 5. ng k kim tra
Cc c s sn xut bao b c nhu cu ng k kim tra cp Giy chng
nhn GMP bao b dc phm sau khi t kim tra, nh gi t GMP bao b dc
phm, np trc tip hoc gi theo ng bu in 01 b h s ng k kim tra
n Cc Qun l dc - B Y t.
Thnh phn h s ng k kim tra:
1. Trng hp ng k kim tra ln u:
a) Bn ng k kim tra GMP bao b dc phm (Ph lc 4 - Mu 1);
b) Bn sao Quyt nh thnh lp c s hoc Giy chng nhn ng k kinh
doanh hoc Giy chng nhn u t c xc nhn ca c s;
c) S t chc nhn s (bao gm h, tn, trnh chuyn mn ca cc cn
b ch cht);
d) S nh xng v cc khu vc kim tra cht lng, bo qun (bao gm
s tng th nh my; s ng i ca nhn vin, nguyn liu ban u, bn
thnh phm; s cp sch phng sn xut, phng kim nghim; s b tr
my mc, thit b,);
) Chng trnh, ti liu v bo co tm tt v hun luyn, o to GMP bao
b dc phm ti c s;
e) Danh mc thit b (sn xut, kim nghim v bo qun) hin c v sn
phm d kin sn xut;
g) Bo co t thanh tra ca c s t gn nht (trong vng 03 thng).
2. Trng hp ng k ti kim tra:
2

Trc 02 thng tnh n ngy Giy chng nhn t nguyn tc, tiu chun
GMP bao b dc phm ht hn, c s tin hnh np h s ng k ti kim tra.
C s sau khi np h s ng k ti kim tra vn c php sn xut theo
phm vi quy nh trong Giy chng nhn.
Thnh phn h s ng k ti kim tra:
a) Bn ng k ti kim tra GMP bao b dc phm (Ph lc 4 - Mu 2);
b) Bo co khc phc cc tn ti trong kim tra ln trc;
c) Bo co tm tt hot ng ca c s trong 03 nm qua;
d) Bo co nhng thay i ca c s trong 03 nm trin khai GMP bao b
dc phm (nu c).
) Bo co t thanh tra ca c s t gn nht (trong vng 03 thng).
3. C s c nhu cu b sung dy chuyn mi np h s ng k nh ng k
kim tra ln u (theo quy nh ti khon 1, iu 5). Trng hp giy chng
nhn GMP cha ht hn nhng c s c nhu cu ti kim tra cng vi ng k
kim tra b sung dy chuyn mi th c th np h s ng k ti kim tra (theo
quy nh ti khon 2, iu 5) ng thi vi ng k kim tra b sung dy
chuyn mi.
iu 6. Thm quyn, trnh t, th tc tip nhn, thm nh h s, kim
tra, v cp Giy chng nhn t nguyn tc, tiu chun GMP bao b dc
phm
1. Thm quyn
Cc Qun l dc chu trch nhim tip nhn v thm nh h s ng k
kim tra, thnh lp on v t chc kim tra thc t, x l kt qu sau kim tra
v cp Giy chng nhn t nguyn tc, tiu chun GMP bao b dc phm cho
c s sn xut bao b.
2. Trnh t, th tc gii quyt
a) Sau khi nhn h s ng k kim tra ca c s theo quy nh ti iu 5,
Cc Qun l dc tin hnh thm nh h s.
b) Trong vng 05 ngy lm vic k t khi nhn c h s v ph thm nh
theo quy nh hin hnh, Cc Qun l dc phi thng bo bng vn bn cho c
s bit v k hoch kim tra hoc tnh trng h s cha t yu cu.
c) Trong vng 20 ngy lm vic k t khi thng bo k hoch kim tra, Cc
Qun l dc phi ra quyt nh thnh lp on, tin hnh kim tra thc t.
iu 7. Kim tra, x l kt qu kim tra v cp Giy chng nhn t
nguyn tc, tiu chun GMP bao b dc phm
1. Thnh phn on kim tra
on kim tra bao gm Trng on, Th k on (Cc Qun l dc) v
cc thnh vin (i din ca Vin Kim nghim thuc Trung ng hoc Vin
Kim thuc thnh ph H Ch Minh, i din S Y t tnh, thnh ph trc thuc
3

Trung ng ni c a im c s sn xut ng k kim tra GMP bao b dc

phm v c th c thm i din ca Cc Qun l dc).
2. Tiu chun cn b kim tra
a) Cn b kim tra phi c trnh i hc tr ln; c kin thc, kinh nghim
v kim tra GMP, nm vng cc nguyn tc, tiu chun GMP, c o to
hun luyn v GMP v thanh tra, kim tra GMP.
b) C phng php thanh tra, kim tra khoa hc, cng quyt, c kh nng
pht hin nhanh cc sai st ca c s ng thi phi a ra c cc bin php
c tnh thuyt phc gip c s khc phc thiu st.
c) Trung thc, khch quan v nghim chnh chp hnh cc quy ch, quy nh
php lut trong qu trnh kim tra.
d) C sc khe, khng ang mc cc bnh truyn nhim.
3. Kim tra
a) on kim tra c trch nhim kim tra ton b cc hot ng ca c s
bao b tip xc trc tip vi thuc theo cc nguyn tc, tiu chun GMP bao b
dc phm v cc qui nh chuyn mn hin hnh:
- Bc 1: Thng bo Quyt nh thnh lp on kim tra.
- Bc 2: C s sn xut trnh by qu trnh trin khai GMP bao b dc
phm; kt qu t thanh tra; bo co tnh hnh hot ng, nhng thay i ca c
s sau 03 nm trin khai v kt qu khc phc nhng tn ti ca ln kim tra
trc (trong trng hp ng k ti kim tra); gii thch, lm r cc vn theo
yu cu ca on kim tra.
- Bc 3: on kim tra tin hnh nh gi thc t (nh xng, khu vc
kim tra cht lng, bo qun, cc tin ch ph tr) v kim tra cc h s, ti
liu c lin quan.
- Bc 4: Tho lun, thng nht thng qua bin bn kim tra.
b) Bin bn kim tra phi ch r cc tn ti trong vic trin khai p dng
GMP bao b dc phm, kt lun v mc p ng nguyn tc, tiu chun
GMP bao b dc phm. Trong trng hp c s sn xut khng nht tr vi
kin ca on kim tra, bin bn phi ghi r tt c cc kin bo lu ca c s.
Bin bn c ph trch c s cng trng on v th k on kim tra k xc
nhn; lm thnh 03 bn, 01 bn lu ti c s, 02 bn lu ti Cc Qun l dc.
4. X l kt qu sau kim tra v cp Giy chng nhn.
a) Nu c s c kim tra p ng cc nguyn tc, tiu chun GMP bao b
dc phm, Cc Qun l dc phi cp Giy chng nhn cho c s trong vng
05 ngy lm vic k t khi kt thc vic kim tra.
Giy chng nhn t nguyn tc, tiu chun GMP bao b dc phm c gi
tr 03 nm k t ngy k.
b) Nu c s c kim tra v c bn p ng cc nguyn tc, tiu chun
4

GMP bao b dc phm v cn mt s tn ti nhng khng nh hng n cht

lng sn phm, c th khc phc c trong thi gian ngn, on kim tra yu
cu c s phi khc phc, sa cha v bo co kt qu khc phc nhng tn ti
m on kim tra nu ra trong bin bn gi v Cc Qun l dc trong vng
2 thng k t khi kt thc vic kim tra.
Trong vng 05 ngy lm vic k t khi nhn c bo co khc phc, Cc
Qun l dc phi cp Giy chng nhn t nguyn tc, tiu chun GMP bao b
dc phm cho c s nu bo co khc phc t yu cu hoc phi thng bo
bng vn bn cho c s bit v tnh trng bo co khng t yu cu.
Qu hai thng k t khi kt thc vic kim tra, nu c s khng gi bo co
khc phc hp l th phi tin hnh ng k kim tra nh ng k kim tra ln
u v np l ph theo quy nh.
c) Nu c s c kim tra cha p ng cc nguyn tc, tiu chun GMP,
c s phi khc phc sa cha cc tn ti c nu ra trong bin bn kim tra.
Sau khi t nh gi t yu cu, c s tin hnh ng k kim tra nh ng k
kim tra ln u v np l ph theo quy nh.
iu 8. Thanh tra, kim tra v x l vi phm
1. Hot ng thanh tra, kim tra nh gi vic tun th cc nguyn tc, tiu
chun GMP bao b dc phm c tin hnh nh k mi 03 nm hoc thanh,
kim tra t xut theo ngh ca c s hoc theo yu cu ca c quan chc
nng do B Y t (Cc Qun l dc) tin hnh.
2. Trong qu trnh kim tra, nu pht hin c s c vi phm nh hng
nghim trng n cht lng sn phm, trng on kim tra yu cu c s tm
dng vic sn xut, lp bin bn, bo co ngi c thm quyn ra quyt nh x
l chnh thc.
iu 9. K hoch trin khai
1. Cc c s sn xut bao b tip xc trc tip vi thuc nghin cu, p dng
nguyn tc, tiu chun GMP bao b dc phm. B Y t ban hnh cc chnh sch
c th v nhng quy nh ph hp nhm thc y vic trin khai, p dng
nguyn tc, tiu chun GMP bao b dc phm.
2. B Y t yu cu cc c s sn xut thuc phi s dng bao b t tiu
chun cht lng, kim sot c cht liu cu thnh v m bo v sinh.
3. Hi ng Dc in Vit Nam ch tr, phi hp vi Vin Kim nghim
thuc Trung ng, Vin Kim nghim thuc thnh ph H Ch Minh, Vin Kim
nh Quc gia v vc xin v sinh phm y t xy dng v trnh cp c thm
quyn ban hnh tiu chun cht lng ca cc loi bao b tip xc trc tip vi
thuc cc c s sn xut, kinh doanh thuc v cc c s sn xut, kinh doanh
bao b tip xc trc tip vi thuc c cn c thc hin.
4. Cc Qun l dc ch tr, phi hp vi cc n v lin quan tng cng
cng tc hu kim, nng cao hiu qu hot ng tin kim, m bo s dng bao
b ng gi dc phm t cht lng, ph hp vi dng bo ch v c tnh
5

ha, l, vi sinh ca thuc; c bit ch trng n nhng loi bao b tc ng

nhiu n cht lng thuc nh bao b khng lm sch c trc khi s dng,
bao b ng gi cc thuc v trng nh thuc tim, tim truyn, thuc nh mt,
nh mi, bao b ng gi thuc cha cc hot cht km bn vng, thuc dng
ng ung, bao b kh kim tra cht lng cu thnh nh bao b lm bng thy
tinh, cht do.
5. L trnh thc hin
a) K t ngy 01/4/2013, cc c s sn xut thuc lu thng trn th trng
ch s dng cc loi bao b cp 1 l loi khng lm sch c trc khi dng
nh bao b ng gi dng cun (mng nhm, mng PVC), u ng xt ca c s
t nguyn tc, tiu chun GMP bao b dc phm. Cc l bao b s dng phi
c phiu kim nghim, tem nhn gc ca nh sn xut km theo.
b) K t ngy 01/01/2014, cc c s sn xut thuc lu thng trn th trng
ch s dng cc loi bao b ng gi cp 1 i vi cc loi bao b ng gi khc
ca c s t nguyn tc, tiu chun GMP bao b dc phm. Cc l bao b s
dng phi c phiu kim nghim, tem nhn gc ca nh sn xut km theo.
c) Trc cc thi im nu trn, B Y t khuyn khch c s sn xut thuc
lu thng trn th trng s dng sn phm ca nhng c s t nguyn tc, tiu
chun GMP bao b dc phm.
iu 10. iu khon thi hnh
1. Thng t ny c hiu lc thi hnh k t ngy 15 thng 10 nm 2012.
1. Cc ng/b Chnh Vn phng, Cc trng Cc Qun l dc, Th trng
cc n v thuc B Y t, Gim c S Y t cc tnh, thnh ph trc thuc Trung
ng, Th trng y t cc ngnh v cc t chc, c nhn c lin quan chu trch
nhim thi hnh Thng t ny.
2. Trong qu trnh thc hin nu c kh khn, vng mc hoc pht sinh lin
quan, ngh cc t chc, c nhn c bo co gi v B Y t (Cc Qun l
dc) kp thi xem xt, gii quyt./.

Ni nhn:

Nh khon 2, iu 10;
UBND cc tnh, thnh ph trc thuc Trung ng;
Vn phng Chnh ph (Phng Cng bo);
Cng thng tin in t Chnh ph;
Cng thng tin in t B Y t;
B T php (Cc kim tra vn bn QPPL);
B Quc phng (Cc Qun y);
B Cng an (Cc Y t);
B GTVT (Cc Y t GTVT);
B trng, cc Th trng BYT;
Hi ng Dc in Vit Nam;
Vin Kim nghim thuc Trung ng;
Vin Kim nghim thuc Tp.HCM;
Vin Kim nh QG v Vc xin v Sinh phm y t;
Tng Cng ty Dc Vit Nam;
Hip hi cc Doanh nghip Dc Vit Nam;
Hi Dc hc Vit Nam;
Lu: VT, PC, QLD (02b).

KT. B TRNG
TH TRNG
( k)

Cao Minh Quang

PH LC 1
NGUYN TC, TIU CHUN GMP BAO B DC PHM
(Km theo Thng t s 14/2012/TT-BYT ngy 31/8/2012 ca B Y t)
Cc nguyn tc, tiu chun GMP bao b dc phm sau y l nhng quy
nh trong lnh vc sn xut bao b tip xc trc tip vi thuc. C s sn xut
bao b cn tham kho thm cc nguyn tc Thc hnh tt theo khuyn co ca
T chc Y t th gii (GMP-WHO) trong qu trnh trin khai, p dng ti c s.
1. Gii thch t ng
Mt s t ng sau y c hiu nh sau:
1.1. Bao b tip xc trc tip vi thuc l bao b dng cha ng, bo v
thuc v c lu thng cng vi thuc, bao gm bao b thng phm v bao b
khng c tnh cht thng phm.
1.2. Bao b thng phm ca thuc l bao b cha ng thuc v lu thng
cng vi thuc. Bao b thng phm ca thuc gm hai loi:
a) Bao b tip xc trc tip vi thuc (cn gi l bao b s cp hay bao b cp
1) l bao b dng cha ng, c tip xc trc tip vi thuc, to ra hnh, khi
hoc bc kn thuc theo hnh, khi, nh mng nhm, mng PVC, ng tup ng
thuc
b) Bao b ngoi (cn gi l bao b th cp hay bao b cp 2) l bao b dng
bao gi mt hoc mt s n v thuc c cha ng trong bao b trc tip,
khng tip xc trc tip vi thuc, nh hp giy, np nhm ngoi
1.3. Bao b thnh phm l sn phm bao b tri qua tt c cc cng on
sn xut, k c ng trong bao gi cui cng v c dn nhn.
1.4. Sn phm l kt qu ca qu trnh sn xut nhm mc ch kinh doanh
hoc tiu dng. Hng ha l sn phm c a vo th trng thng qua trao
i, mua bn, tip th.
1.5. Tiu chun cht lng sn phm bao gm cc quy nh v ch tiu, yu
cu k thut, phng php th nghim, yu cu v bao gi, bo qun v cc yu
cu khc lin quan n cht lng; do c s cng b, p dng, hoc t xy
dng, cng b p dng; c dng lm chun phn loi, nh gi, nhm nng
cao cht lng sn phm. Tiu chun cht lng phi ph hp vi quy chun k
thut tng ng, c lin quan do c quan nh nc c thm quyn ban hnh.
1.6. Nguyn liu l thnh phn chnh ca bao b tip xc trc tip vi thuc,
quyt nh cht lng bao b thnh phm v do c tc ng, nh hng n
cht lng thuc, nh nhm (bt nhm, mng nhm to v bm, v x, tup kem,
m), polyme (mng PVC, chai, l nha), thy tinh (l, ng), cao su (nt), keo
dnh, mc in, cht mu
1.7. Sn phm trung gian l sn phm c ch bin mt phn, phi tri
qua mt s giai on sn xut na c bn thnh phm.
7

1.8. Bn thnh phm l sn phm tri qua mt s cng on sn xut, cn

phi tri qua thm mt s cng on na c thnh phm.
1.9. Sn phm ch ng gi l sn phm qua cc giai on sn xut, tr
cng on ng gi.
1.10. Sn xut hiu theo ngha rng l bao gm cc hot ng lin quan n
sn phm, bt u t giai on nghin cu, pht trin sn phm, n hot ng
cung ng v nh gi cht lng nguyn vt liu ban u; sn xut v kim
tra/gim st trong qu trnh sn xut; cc hot ng kim tra cht lng, nh
gi h s l, xut xng; v qu trnh bo qun, phn phi sn phm v theo di
hu mi. Sn xut hiu theo ngha hp l vic tip nhn nguyn vt liu, pha ch,
ng gi v thc hin cc bin php kim sot nhng yu t nh hng n cht
lng sn phm.
1.11. Kim tra trong qu trnh sn xut l vic kim tra, gim st trong qu
trnh sn xut, bao gm nh gi tnh trng, iu kin mi trng sn xut,
nhm ngn nga, gim thiu vic nhm ln, nhim, nhim cho, m bo
tun th quy trnh sn xut v xc nhn s ph hp ca ton b l, m sn phm
theo tiu chun m kt qu phiu kim nghim mu i din cha phn nh ht
c cht lng ton b l/m sn xut.
1.12. L sn phm l bao gm cc sn phm ng nht v cht lng c
sn xut vi cng nguyn liu v ph liu, bi mt quy trnh v cng mt t.
Trong thc t, mt l c th bao gm mt s m, cc m ny phi c tp trung
li mt cng on nht nh nhm m bo tnh ng nht l.
1.13. Bit tr l tnh trng nguyn liu, sn phm trung gian/bn thnh phm
v thnh phm c bo qun ring bit bng bin php vt l hoc bi cch
thc ph hp, trong thi gian ch kim nghim, nh gi quyt nh chp
nhn s dng, sn xut tip, xut xng, tr nh cung cp, ti ch hay loi b.
1.14. Khu vc sch l vng c kim sot v mc nhim tiu phn bi v
vi sinh vt; c thit k, xy dng v s dng theo cch thc sao cho c th
gim thiu s pht sinh, pht trin v tch t cc yu t gy nhim. Nh sn xut
c th quy nh yu cu v nhit , m, nh sng hay n cho cc phng
sch ph hp vi mc ch s dng v iu kin lm vic ca nhn vin.
1.15. Cht gi l bung kn c hai hay nhiu ca, l li vo, ra cc khu vc
sch dnh cho ngi, nguyn vt liu, nm gia hai hay nhiu phng c cp
sch khc nhau. Trong mt s trng hp, nh sn xut c th b tr thm
airshower hoc lp t t gn qut ht/thi hoc pass-box dng chuyn dng
c, sn phm c tc dng nh cht gi.
2. H thng qun l cht lng
2.1. C s sn xut bao b cn phi thit lp mt h thng qun l cht lng
hot ng mt cch ton din, thng nht v c hiu qu; da trn cc nguyn
tc c bn v thc hnh tt sn xut.

2.2. H thng qun l cht lng l cng c thc hin chnh sch cht
lng ca c s; bao gm c cu t chc, chc nng, trch nhim, quy trnh,
hng dn v cc ngun lc thc hin cng tc qun l cht lng. H thng
qun l cht lng khng ngng c cng c v hon thin thng qua hot
ng t thanh tra.
2.3. H thng qun l cht lng lin quan n tt c cc lnh vc sn xut v
kim tra cht lng, bao gm cc hot ng cung ng, bo qun, sn xut, kim
nghim, vic kim sot mi trng sn xut, vic vn hnh thit b, cc ph tr
c lin quan v cng tc theo di h thng phn phi, gim st hu mi.
2.4. H thng qun l cht lng bao gm b phn qun l sn xut v b
phn qun l hay m bo cht lng. Hai b phn ny phi do nhng ngi
khc nhau ph trch. Nhng ngi ny c s hp tc v cng chia s trch
nhim vi nhau v cht lng nhng phi c lp, khng ph thuc ln nhau.
B phn qun l cht lng bao gm phng m bo cht lng v phng kim
nghim. Phng m bo cht lng l n v iu hnh trc tip h thng cht
lng. Phng kim nghim l n v tc nghip chuyn mn, c th thuc phng
m bo cht lng. C s c th gp chung hoc b tr ring mt s b phn
lin quan n cht lng nh thit b c in, bo qun; phn cng ngi chu
trch nhim theo di h thng phn phi, gii quyt khiu ni, thu hi sn phm.
2.5. C s cn phi thit lp v duy tr vic kim tra, gim st qu trnh sn
xut. Hot ng ny c thc hin bi nhm cc nhn vin trc tip sn xut
v nhn vin IPC. Nhim v cc nhm nhn vin ny phi c quy nh r
rng vi tn sut ph hp i vi nhng hot ng c th. Ty thuc quy m,
m hnh t chc v nng lc qun l ca c s, nhn vin IPC c th thuc b
phn m bo cht lng, kim tra cht lng hoc/v thuc b phn sn xut.
2.6. h thng cht lng hot ng c hiu qu, c s sn xut cn xy
dng tiu chun khch hng ni b gia cc b phn ca nh my theo chu
chuyn sn phm, t khu cung ng nguyn vt liu u vo, nghin cu sn
xut th, qua cc cng on sn xut, ng gi, n hot ng bo qun v phn
phi sn phm. Cc b phn thc hin vic nh gi s tun th tiu chun ni
b ln nhau h tr cng tc qun l cht lng ton din.
3. Nhn s v o to
3.1. Nguyn tc chung
a) C s sn xut bao b phi c cn b, nhn vin c sc khe, trnh
p ng yu cu. C bn m t cng vic cho mi nhm i tng nhn vin.
b) Cc cn b ch cht phi c trnh v kinh nghim thc tin m bo
thc thi tt nhim v c giao.
c) Phi c vn bn quy nh r nhim v, quyn hn ca cc cn b ch
cht. Cn b ch cht c th y quyn cng vic cho cn b cp ph hoc nhn
vin di quyn nhng khng c thoi thc trch nhim.

d) Trng b phn qun l sn xut v trng b phn qun l cht lng c

mt s trch nhim chung hoc cng phi hp thc hin mt s cng vic lin
quan n cht lng nh nh gi thit b sn xut, thm nh quy trnh sn
xut nhng phi quy nh c th trnh s chng cho hoc li khong
trng trong vic p dng GMP.
3.2. Nhim v v quyn hn ca trng b phn qun l sn xut
a) iu hnh hot ng sn xut v chu trch nhim kim tra, gim st nhn
vin thc hin ng cc quy nh trong sn xut;
b) T chc son tho, ph duyt v hun luyn v cc SOP trong sn xut;
c) Tham gia son tho quy trnh sn xut, quy trnh v sinh thit b sn xut,
nh xng, xy dng tiu chun sn phm trung gian, bn thnh phm;
d) Ch tr hot ng nh gi lp t, vn hnh, hiu nng cc thit b sn
xut; Tham gia hot ng thm nh quy trnh sn xut, quy trnh v sinh;
) m bo nh xng c bo dng, iu kin mi trng sn xut p
yu cu; cc thit b sn xut c bo tr, trong tnh trng hot ng tt, ng
h hin th thng s vn hnh c kim nh, hiu chun;
e) m bo nh xng thit b, dng c sn xut c v sinh sch, dn
quang dy chuyn trc khi sn xut, sp xp nguyn vt liu, sn phm gn
gng, khng b nhm ln, nhim, nhim cho;
g) m bo vic sn xut c thc hin ng quy trnh, kt qu thc hin
c ghi chp kp thi ng quy nh, h s l cng on c kim tra bi
nhn vin c phn cng chnh thc v ton b h s l c sot xt;
h) T chc hot ng kim tra trong qu trnh sn xut v m bo tnh ng
nht l/m sn phm trong qu trnh sn xut;
i) Gn nhn tnh trng bit tr i vi sn phm ch chuyn tip cng on
hoc ch xut xng;
k) Tham gia xy dng chng trnh, ni dung v ch tr vic hun luyn o
to cho nhn vin sn xut;
l) Tham gia hot ng t thanh tra.
3.3. Nhim v v quyn hn ca trng b phn m bo cht lng
a) Xy dng chnh sch cht lng, s tay cht lng ca cng ty.
b) iu hnh b phn m bo cht lng v t chc trin khai hot ng
ca h thng qun l cht lng;
c) Chu trch nhim ph duyt hoc kim tra cc quy trnh sn xut, quy
trnh v sinh, cc SOP lin quan n cht lng. T chc vic xy dng cc SOP
ca b phn m bo cht lng. m bo cc quy trnh c r sot nh k;
d) Ph duyt cc tiu chun khch hng ni b v gii quyt thc mc v
cht lng sn phm gia cc b phn trong cng ty;
10

) Tham gia nh gi nh cung cp. C quyn chp nhn s dng hoc khng
s dng i vi nguyn liu, bao b. Gn nhn tnh trng chp nhn hoc loi b
i vi nguyn liu u vo;
e) Xy dng k hoch thm nh gc v t chc hot ng thm nh quy
trnh sn xut;
g) nh gi ton b qu trnh sn xut (h s l sn phm, phiu kim
nghim, kt qu nh gi iu kin sn xut, kim tra trong qu trnh sn
xut). Quyt nh xut xng v chu trch nhim v cht lng thnh phm;
h) Theo di vic sn xut/kim nghim theo hp ng. Chu trch nhim gii
quyt khiu ni, thu hi sn phm;
i) Xy dng chng trnh, k hoch v t chc vic o to hun luyn, o
to cn b, nhn vin ton nh my;
k) Xy dng chng trnh, k hoch v t chc hot ng t thanh tra;
l) Lu tr h thng ti liu v h s v cht lng.
3.4. Nhim v v quyn hn ca trng phng kim tra cht lng
a) iu hnh phng kim nghim;
b) Xy dng s tay cht lng phng kim nghim;
c) Ch tr, phi hp son tho, r sot, cp nht cc tiu chun cht lng
nguyn liu, bao b, thnh phm, cc SOP c lin quan;
d) m bo c s vt cht phng kim nghim c bo tr, bo dng v
thit b phn tch c kim nh/hiu chun y ;
) Chu trch nhim t chc thm nh v ph duyt hoc kim tra cc quy
trnh kim nghim. Phi hp b phn m bo cht lng v b phn sn xut
thc hin thm nh quy trnh sn xut, quy trnh v sinh;
e) Gn nhn tnh trng bit tr ch kim nghim, ch ti kim i vi
nguyn nguyn liu, bao b. T chc ly mu, lu mu v kim tra cht lng
i vi nguyn liu, bao b, sn phm trung gian, bn thnh phm, thnh phm,
th n nh v cc th nghim c lin quan trong vic nh gi mi trng
sn xut v v sinh thit b sn xut;
g) Theo di kim nghim theo hp ng v nh gi cc phiu kim nghim
gc. Tham gia nh gi nh cung cp. m bo tiu chun cht lng nguyn
liu, bn thnh phm nhp v ph hp vi tiu chun thnh phm v cc quy
chun lin quan;
h) Tham gia xy dng chng trnh, ni dung v ch tr vic hun luyn o
to cho nhn vin phng kim nghim;
i) Tham gia hot ng t thanh tra;
k) Lu tr phiu kim nghim, h s kim nghim, s tay kim nghim vin
v cc h s, ti liu c lin quan.
11

3.5. o to
a) C s phi xy dng chng trnh, k hoch, ni dung o to, hun
luyn cc kin thc c bn v GMP bao b dc phm, kin thc chuyn mn,
nghip v, quy trnh sn xut, kim nghim, cc SOP cho ton b cn b,
nhn vin.
b) Chng trnh, k hoch, ni dung cn phi ph hp vi tng nhm i
tng cn b, nhn vin, phi c cp nht, duy tr thng xuyn v c
ngi c thm quyn xem xt, nh gi, ph duyt.
c) Ngi hun luyn phi c kin thc, c o to v GMP v cc kin
thc c lin quan, l ngi ca c s hoc do c s mi tham gia.
d) C s cn phi nh gi kt qu hun luyn, o to v lu y h s.
4. Nh xng
4.1. Nh xng c thit k, xy dng p ng yu cu phng chng lt
bo, chng cn trng, chut b xm nhp; c v tr ngn cch cc ngun ly
nhim t bn ngoi.
4.2. Khu vc sn xut bao b tip xc trc tip vi thuc phi b tr bit lp
vi khu vc sn xut cc loi sn phm khc v cn ph hp vi cc khu vc
khc nh kho bo qun nguyn liu ban u, vt liu bao gi, thnh phm.
4.3. Vic thit k, xy dng phi ph hp vi dy chuyn sn xut (dng sn
phm, cng sut d kin). Cc phng sn xut cn c b tr thun chiu di
chuyn ca nhn vin, nguyn liu, sn phm v rc thi.
4.4. Cc phng trong khu vc sn xut phi rng thun li cho vic lp
t, bo dng thit b, t nguyn liu, sn phm, dng c sn xut v thao
tc ca nhn vin.
4.5. Cp sch ca phng sn xut phi ph hp vi cc loi sn phm nh
bao b ng gi thuc v trng, thuc ung, thuc dng ngoi khng c vt
thng h; ph hp vi nhng bao b phi lm sch (ra, hp, sy, lm kh)
trc khi dng hay khng; ph hp vi cng on sn xut (khi sn phm ang
trong tnh trng h, tip xc trc tip vi khng kh (cn, pha ch), hoc bao gi,
bo qun... (Ph lc 2).
4.6. i vi dy chuyn sn xut cc sn phm khng lm sch c trc
khi ng gi dc phm nh cun mng PVC/mng nhm dng p ti/v
thuc, tup nhm nh sn xut phi duy tr cp sch nhng khu vc ny tng
ng vi cp sch khu vc ng gi s cp i vi loi dc phm tng ng.
4.7. Cc phng cn, cp pht, ly mu nguyn liu, phng pha ch, bit tr
bn thnh phm, hnh lang sch, bao gi ln 1 phi c b tr trong khu vc
c cp sch thch hp, cng vi cc bin php khc nh nh gi nh cung
cp v kim sot gii hn nhim khun nguyn vt liu u vo m bo
sn phm t tiu chun sch trong ton l thnh phm.
12

4.8. nhng khu vc c kim sot cp sch, trn, tng, sn phi nhn, d
lm v sinh, gc tip ni c bo trn, c h thng cp kh gn mng lc vi s
ln trao i khng kh v mc chnh p ph hp, c cc airlock hoc pass-box
cho nguyn liu/sn phm, cc airlock nhn vin (c th ng thi l phng
ra/sy tay, thay trang phc lao ng, c k inox xoay dp/giy
thng/sch), n chiu sng c lp sao cho c th lm v sinh t bn
ngoi gim thiu tch t bi bn, nhim hay nhim cho. Cc thng s nh
s ln trao i khng kh, chnh lch p sut gia cc phng vi hnh lang cn
c thit lp v duy tr gim thiu tnh trng nhim, nhim cho.
4.9. Nhit , m, nh sng, khng gian, n, rung, t trngti
cc phng sn xut cn kim sot cho ph hp vi quy trnh sn xut, cc thao
tc vn hnh thit b, tnh chu nhit, m ca sn phm v iu kin lm vic ca
nhn vin (Ph lc 2).
4.10. Vic cn, cp pht nguyn liu nn thc hin trong khu vc sn xut.
C phng bo qun nguyn liu sau khi cn chia l, phn m vi cc k gi,
cha v bin php qun l thch hp khc ngn nga s nhm ln.
4.11. Cn phi c cc khu vc bo qun nguyn liu ban u, bao gi v
thnh phm. Cc khu vc ny c thit k, xy dng c nhit , m, nh
sng ph hp v c trang b cc gi k bo qun. C cc khu vc bit tr (ch
kim nhn, xut xng, nhp kho, ch x l hay tr nh cung cp), khu vc bo
qun hng t, bo qun sn phm ch tiu hy. Nu khng th tch ring cc
khu vc ny th phi c bin php qun l thch hp, trnh nhm ln, ln xn.
Vic ly mu nu thc hin ti kho th phi c bin php ph hp trnh s
nhim hay nhm ln. i vi cc sn phm b tc ng bi nhit , m nh
mng PVC, mng nhm nh sn xut phi duy tr iu kin bo qun ph hp
(nhit 28 0C, m 70 %), trnh nh hng n cht lng (m mc,
gim kt dnh hoc khng duy tr c kn ti/v) ca dc phm trong
qu trnh lu hnh.
4.12. B tr phng bo qun khun, mu, ph kin thit b c th tho ri.
Cn c k hiu nhn bit hoc m ha trnh nhm ln.
4.13. Cc khu vc cha rc thi, x l nc thi, bo qun ha cht d chy
n, nh xe, phng thay/gi qun o/t trang c nhn, phng v sinh, nh n,
phng ngh phi b tr cch bit khu vc sn xut, kim nghim v bo qun.
4.14. C s cn phi tin hnh nh gi tng th iu kin sn xut trc khi
a vo vn hnh v thc hin theo nh k.
5. Thit b
5.1. Nh sn xut phi c cc thit b, dng c cn thit, ph hp vi hot
ng sn xut cc mt hng d kin sn xut.
5.2. Cng vi vic thit k, xy dng nh xng hp l, cn b tr, lp t
thit b sn xut (s lng, cng sut) cho tng cng on mt cch ph hp.
13

5.3. Cc thit b sn xut phi c thit k, ch to, lp t thun li v

m bo an ton khi vn hnh, d bo tr, bo dng, lm v sinh, trnh tch t
bi bn v nhng tc ng bt li n sn phm.
5.4. C cng v h s nh gi lp t, vn hnh, hiu nng, cc SOP
vn hnh v s nht k vn hnh, nht k lm v sinh i vi mi thit b.
5.5. Phi c chng trnh, ni dung bo tr, bo dng nh k cho cc thit
b. Thit b cn c gn nhn ch r tnh trng c bo tr bo dng, hot
ng tt hoc ang b h hng, khng c s dng.
5.6. Cn v cc thit b/ng h o p lc phi c kim nh bi c
quan chc nng theo quy nh. Cc thit b/ng h hin th thng s khc cn
c hiu chun m bo tin cy ca kt qu o.
5.7. Cn trang b phng tin vn chuyn ph hp trong qu trnh phn phi
sn phm v c bin php kim sot iu kin bo qun (nhit , m, )
trong qu trnh lu thng i vi nhng bao b chu tc ng nh mng nhm,
cun p ti,
6. V sinh v iu kin v sinh
6.1. Nguyn tc chung
a) Bao b cp 1 tip xc trc tip vi thuc nn vn v sinh trong sn xut
bao b cp 1 cng phi c quan tm nh trong sn xut thuc.
b) Sn phm c th b nhim bn v vt l, ha hc, vi sinh vt t nh xng,
khng kh, thit b, dng c sn xut, nguyn vt liu u vo, nhn vin sn
xut hoc nhim cho. Nh sn xut phi c chng trnh, ni dung chi tit cho
vic v sinh nh xng, thit b, nhn vin v cc bin php kim sot nhim,
nhim cho khc. Cc SOP v sinh cn c thm nh/nh gi.
c) Mi nhn vin c lin quan u phi c hun luyn v c nh gi
vic hun luyn cc SOP v sinh c nhn, nh xng, thit b, dng c.
d) Cn c du hiu nhn bit tnh trng sch ca phng sn xut, thit b,
dng c, trang phc bo h lao ng v ngy lm sch tip theo.
) Vic lm v sinh cn c ghi chp v lu gi.
6.2. V sinh c nhn
a) Nhn vin phi c sc khe tt. Hn ch nhn vin ang mc bnh ly
nhim hay c vt thng h nh hng n sn phm i vo khu vc sn xut.
b) Phi c bo h lao ng v quy trnh v sinh c nhn ph hp vi cp sch
phng lm vic. Cm n ung, ht thuc hay mang dng c nhn vo khu
vc sn xut.
c) Ch ngi c phn s mi c php vo nh xng. Khch tham quan
mun vo nh xng phi lm v sinh c nhn nh nhn vin sn xut.
d) C s phi c bin php qun l v hnh thc gim st m bo mi
14

ngi tun th ng quy nh v v sinh c nhn.

6.3. V sinh thit b v dng c
a) Phi c quy trnh v sinh cho mi loi thit b. Phng php v sinh, thi
gian thc hin, loi cht ty ra cn c thit lp t thc tin lm v sinh i
vi sn phm kh lm sch nht.
b) Cn b tr ring phng v sinh cc dng c, thit b sn xut c th tho
ri, di chuyn c. C phng bo qun dng c sch sau khi lm kh, sch.
c) Nc trng ln cui hay kh nn lm kh phi c tinh khit, cp sch
ph hp vi cp sch phng, thit b sn xut sn phm cng on .
6.4. V sinh nh xng
a) Nh xng phi c lm v sinh thng xuyn. nh k tit trng h
thng cung cp khng kh v cc phng sn xut.
b) Cn c quy nh trch nhim lm v sinh cc airlock, pass-box, hnh lang
chung, ng cp/hi ca h thng iu ha khng kh,
c) Cn c quy nh v vic phn loi, thu gom, x l rc thi sinh hot v
cht thi nguy hi m bo cng tc v sinh mi trng.
7. Nguyn vt liu
Nguyn vt liu bao gm nguyn liu ban u v bao gi. Nguyn liu
ban u c th l thy tinh, nha PVC, cao su, mc in hoc l sn phm cha
hon tt nh ng thy tinh, mng PVC, mng nhm dt mng sn.
Quy nh chung
7.1. Cc nguyn liu ban u phi c kim nghim, nh gi hoc kim
sot ph hp vi tiu chun cht lng, ang trong thi hn s dng, c b
phn qun l cht lng chp nhn mi a vo s dng.
7.2. Cn phi c phiu kim nghim gc hay giy chng nhn xut xng
ca nh my sn xut i vi nguyn liu ban u. C s sn xut bao b tip
xc trc tip vi thuc phi nh k ly mu kim tra cht lng hoc c bin
php nh gi ph hp i vi nhng tiu ch, php th m phng kim nghim
ca c s khng thc hin c nh xc nh thnh phn ha hc, gii hn kim
loi nng ca nguyn liu ban u.
7.3. Trong trng hp c s sn xut bao b nhp sn phm cha hon tt v
gia cng th ngoi vic ly mu kim tra cht lng, c s cn phi nh gi
nh cung cp, xem xt h s l sn phm, m bo sn phm t tiu chun
cht lng v ng nht trong ton b l hng.
7.4. Nc s dng sn xut bao b c coi l nguyn liu ban u, cng
vi nc ngun (nc my thnh ph), cn c nh k ly mu ti cc im
s dng kim tra cht lng.
7.5. C s phi lu y h s kim tra, kim sot cht lng v h s
15

nh gi nh cung cp i vi nguyn liu ban u.

Mc in
7.6. Mc in l nhng ch phm gm c cc thnh phn nh cht mu, cht
kt dnh, cht ha do, cht lm kh, c ha tan, phn tn trong nc hay
dung mi hoc c x l bi nng lng UV (ultraviolet), EB (electron beam).
7.7. Mc dng trong cng nghip dc c mc in nguyn liu (v nang) v
mc in bao b tip xc trc tip vi thuc. Mc in bao b tip xc trc tip vi
thuc gm c mc dng in mt ngoi l, np, ng, cha ng thuc (t c
nguy c thi, nhim ln thuc) v mc in bao b ng gi dng cun, khng th
lm sch c trc khi s dng (mng nhm, mng cht do, ti ng cht ht
m, ).
7.8. i vi mc in bao b s cp c nguy c thi, nhim (mc in) ln thuc,
cht lng mc ti thiu phi t tiu chun dng cho thc phm (FDA). Khng
c s dng loi mc in khng kim sot c c t nh mc in gc dung
mi. C s phi cung cp h s chng minh tnh an ton ca mc in bao gm
phiu kim nghim gc v cc ti liu c lin quan cho c quan chc nng khi
c yu cu.
Mng nhm, mng cht do
7.9. Bao b mng nhm, mng cht do c ng gi dng cun nn khng
lm sch c trc khi dng p v, p ti. Do cn phi kim sot cht ch
iu kin sn xut m bo yu cu v sinh trong qu trnh sn xut.
7.10. Cc giai on dt phin, ct, in, cun cun, bao gi, (khi sn phm
ang trong tnh trng h, tip xc trc tip vi mi trng khng kh xung
quanh) phi c thc hin khu vc t cp sch D.
7.11. Cc cun mng nhm, mng cht do trc v sau khi ct, in, cun
cun phi t yu cu v gii hn nhim khun (nm mc, nm men: 19
cfu / 100 cm2; vi khun hiu kh: 190 cfu / 100 cm2; cc vi khun gy bnh
E.coli, S.aureus, P.aeruginosa, Salmonella: khng c c).
7.12. C s sn xut mng nhm, mng cht do phi p ng cc quy nh
ti cc mc 7.1, 7.2 v 7.3, Ph lc 1.
8. Sn xut
8.1. Hot ng sn xut phi c t chc, qun l v gim st bi nhng
ngi c trnh v thc hin bi i ng nhn vin c kinh nghim.
8.2. Ty theo tiu chun thnh phm v tnh cht ca sn phm trung gian,
bn thnh phm m b tr cng on sn xut ti cc phng c cp sch ph
hp.
8.3. Ch tin hnh cc thao tc sn xut, bao gm vic cn, cp pht nguyn
liu, khi phng c dn quang, thit b sch, trong tnh trng hot ng tt v
cc nguyn liu u c gn chp nhn. Nguyn liu cn phi c lm v
16

sinh/g b bao gi bn ngoi trc khi a vo khu vc sch.

8.4. Phi thc hin ng quy trnh sn xut v ghi kt qu y , kp thi
vo h s l. Hn ch ti a vic lm khng ng thng s quy nh. Trng
hp bt kh khng th cn phi c ngi c thm quyn cho php v ghi r l
do.
8.5. Gn nhn nhn dng tnh trng bit tr, chp nhn hay loi b
(vng/trng, xanh, ) i vi sn phm trong qu trnh sn xut, k c nguyn
liu sau chia l, phn m v c phng lu gi vi k gi, thng cha thch hp.
8.6. Nh sn xut cn phi t chc hot ng kim tra trong qu trnh sn
xut, nht l vi nhng cng on, cc thng s trng yu, xc nhn s ph
hp ca ton b l, m sn phm theo tiu chun cht lng. Bn cnh vic xem
xt phiu kim nghim v nh gi h s l, cn phi cn c vo kim tra gim
st trong qu trnh sn xut quyt nh cho php hay khng vic sn xut tip
hay xut xng thnh phm.
8.7. D, ph phm trong qu trnh sn xut phi ghi r tnh trng, s lng,
v bo qun ni ph hp trnh nhm ln.
9. Kim tra cht lng
9.1. Nguyn tc chung
a) C s sn xut bao b dc phm phi c phng kim nghim v phi
c thit k v xy dng ph hp vi cc hot ng kim tra cht lng sn
phm v nh gi mi trng sn xut ti c s.
b) Phi nhn lc c trnh ph hp, c hun luyn, o to p
ng yu cu cng tc. Cn b tr ngi c trnh i hc chuyn ngnh dc,
ha hc, vi sinh ph trch phng, cc b phn.
c) Phi c phng kim nghim vi sinh vt vi cp sch theo quy nh GMPWHO p ng yu cu nh gi mi trng sn xut v kim tra nhim
khun ca sn phm.
d) Phi trang b cc thit b, cn phn tch, dng c o lng c kim
nh/hiu chun, lun trong tnh trng hot ng tt kim tra cht lng sn
phm theo tiu chun c s v th nghim c nhng ch tiu chnh ca
nguyn liu ban u.
Cc c s sn xut cun mng nhm, mng PVC phi kim nghim c
cc ch tiu v dy, kh nng nh hnh, nh lng khi lng mng, bn
c hc, co dn, bm dnh v kn ca ti, v sau khi p dn.
) Phi c h thng h s ti liu, c cc quy trnh thao tc chun, quy trnh
phn tch, kim nghim v c ngi c thm quyn ph duyt phc v hot
ng kim tra cht lng.
9.2. Ly mu v lu mu
a) Vic ly mu phi c tin hnh bi nhn vin c o to, theo quy
17

trnh thao tc chun v cho mi ln nhp hng/tng l nguyn liu ban u cho
cc l sn phm m bo tnh i din cho c l hng nhp v.
b) Thit b, dng c v cch thc ly mu c thc hin sao cho trnh s
nhim hay nhim cho. Cn tnh n cc yu cu c bit i vi cc v t li u
c c tnh, tc ng n mi trng v nh hng nhn vin ly mu.
c) S lng mu lu v thi gian lu mu ca mi i tng phi ph hp
vi vic theo di cht lng v phc v gii quyt khiu ni sn phm.
9.3. Kim nghim
a) Cng vi vic kim tra, gim st trong qu trnh sn xut, vic kim tra
cht lng phi m bo i din cho c l sn phm.
b) Phi c h s kim nghim, s tay kim nghim vin, nht k s dng
thit b phn tch.
c) Trong mt s trng hp nht nh, c th cn c phiu kim nghim gc
ca nguyn liu ban u xem xt vic a vo s dng hay khng (Xem thm
mc 7.2, Ph lc 1).
9.4. Theo di n nh
B ph n kim tra cht lng cn phi nghin cu n nh a ra hn
s dng iu kin bo qun thch hp i vi mi loi thnh phm bao b tip
xc trc tip vi thuc (Xem thm mc 4.12, 5.7, Ph lc 1).
10. Thm nh
10.1. Nguyn tc chung
a) C s sn xut phi xc nh nhng cng vic thm nh cn thc hin
chng minh cc yu t trng yu tc ng n cht lng sn phm (nh xng,
ph tr, thit b, quy trnh) c kim sot. Cc yu t ny cn c xc nh
r rng vi chng trnh ph hp nu trong k hoch thm nh gc.
b) Cn phi thnh lp ban thm nh, trong c nhng nhn s am hiu,
tinh thng lnh vc tham gia. C s c th mi thm chuyn gia bn ngoi.
c) Cn phi xy dng cng thm nh bao gm phng php thc hin,
thit b s dng, nhn s tham gia, tiu chun chp nhn, thi gian ti thm nh,
cho mi ni dung thm nh. Thc hin ng vi cng c ph
duyt. Lu gi y kt qu thc hin, bo co tm tt v kt lun.
d) Sau t thm nh tng th ban u, c s sn xut cn phi m bo duy
tr lin tc hot ng thm nh vi ni dung v tn sut ph hp cho mi yu t
cn nh gi. Bt c s thay i no ca cc yu t c lin quan u phi c
xem xt, cn nhc quyt nh vic c phi thm nh li hay khng.
10.2. Mt s ni dung thm nh, nh gi trong GMP bao b dc phm
a) nh gi kt qu hun luyn, o to nhn vin;
b) nh gi mi trng sn xut (s liu, d liu o c, quan trc v nhit
18

, m, cp sch), cp sch v tnh hp l ca phng kim nghim vi sinh

vt; nh gi hiu nng cc tin ch ph tr (h thng cp kh nn, nc sch,
phng chy cha chy, x l cht thi);
c) Kim nh, hiu chun thit b, ng h, o lng;
d) nh gi (hiu qu thc hin ng theo) cc quy trnh thao tc chun;
) nh gi thit b sn xut, thit b kim nghim;
e) Thm nh quy trnh phn tch, quy trnh v sinh v quy trnh sn xut;
g) nh gi nh cung cp; sn xut (gia cng), kim nghim theo hp ng.
11. Ti liu v h s
11.1. H s ti liu l mt phn thit yu ca h thng m bo cht lng v
cn phi c cho mi kha cnh ca GMP.
11.2. Mc ch ca h s ti liu l xc nh tiu chun, quy trnh, phng
php, cch thc tin hnh; nhn vin lin quan hiu cn phi lm g, lm vo
lc no; ngi c thm quyn c c tt c thng tin cn thit khi xem xt,
quyt nh xut xng sn phm v x l khiu ni v cht lng sn phm;
m bo s liu cn thit cho vic thm nh, r sot, thng k; v cung cp
bng chng cho thanh tra.
11.3. Cn phi c vn bn quy nh vic son tho, trch dn, tham chiu, ph
duyt, sao chp, phn pht, ph bin, hun luyn, p dng, ghi chp, r sot, sa
i, cp nht, lu tr v tiu hy cc h s, ti liu.
11.4. Trng hp p dng h thng my tnh trong vic qun l h s, ti liu
th phi c vn bn quy nh v vic truy cp, chnh sa, sao chp, lu tr
11.5. Vic thit k, qun l v s dng h thng h s ti liu ty thuc vo
nh sn xut. Mt s trong cc h s ti liu c bn sau y c th c gp
chung hoc tch ring.
Mt s h s ti liu chnh
11.6. Cc quy trnh thao tc chun
Quy trnh thao tc chun (Standard operation process - SOP) l vn bn c
ngi c thm quyn ph duyt, a ra cc ch dn thc hin mt hoc mt s
thao tc. Quy trnh thao tc chun khng nht thit phi ch p dng ring
bit cho mi sn phm, nh SOP vn hnh, bo dng hay v sinh mt thit b
sn xut. Mt s SOP c th c s dng b sung cho quy trnh sn xut, v
d SOP quy nh vn hnh my in, hoc b sung cho h s l sn phm nh
SOP quy nh kim tra trong qu trnh sn xut cng on in mng nhm, hoc
c qun l ring nh SOP v thm nh h thng iu ha khng kh, hay
SOP nh gi thit b sn xut.
11.7. H thng nhn
a) C s cn phi thit lp h thng nhn theo mu thng nht cho cc nhm
19

i tng nh nguyn liu u vo, vt liu bao gi, nhn sn phm lun chuyn
trong qu trnh sn xut, thnh phm; nhn phng, thit b, khun mu, dng
c
b) Nhn cn phi c thng tin cn thit v th hin c tnh trng (bit
tr, loi b, chp nhn s dng hay c php sn xut tip, ngy thng v sinh,
bo tr, bo dng, kim nh, hiu chun, thi gian thc hin tip theo).
c) Nhn bao b thnh phm ti thiu phi c cc thng tin sau y: Tn sn
phm, tn/a ch/s in thoi c s sn xut/nhp khu, quy cch ng gi, s
l/ngy sn xut, hn s dng, iu kin bo qun, cnh bo hay thn trng cn
thit.
11.8. Tiu chun cht lng v h s kim nghim
a) C s sn xut bao b phi xy dng tiu chun cht lng ca bao b
thnh phm, trn c s xc nh tiu chun chp nhn i vi nguyn liu
ban u trong vic nh gi nh cung cp. Trong trng hp cn thit c s c
th xy dng tiu chun cht lng vt liu bao gi, sn phm trung gian, bn
thnh phm (xem thm mc 2.6, Ph lc 1).
b) Cc tiu chun cht lng ca bao b thnh phm v nguyn liu ban u
phi ph hp vi nhng chuyn lun chung v bao b trong Dc in Vit
Nam. C s c th tham kho v p dng cc dc in thng dng nh Dc
in Anh, Hoa K, Nht Bn, Chu u, Quc t hoc theo quy nh ca Lut v
sinh an ton thc phm ca Nht Bn v tiu chun i vi thc phm, ph gia
thc phm.
c) Cc ch tiu, yu cu k thut ca bao b thnh phm v nguyn liu ban
u phi tng thch vi loi thuc c ng gi (thuc v trng, thuc ung
hay dng ngoi, ), p ng c yu cu bo v thuc, khng c tng k
vi thuc, phi m bo tnh an ton v tin dng cho ngi s dng.
d) Phng php kim nghim cn c thm nh v nh gi trong hon
cnh thc t ti c s (xem thm cc mc 7.2, 9.1, 12.2, Ph lc 1).
) Phiu kim nghim bao b thnh phm ti thiu phi c cc thng tin sau
y: S phiu, tn sn phm (mu), tn/a ch/s in thoi c s sn xut/nhp
khu, s l/ngy sn xut, hn s dng, c l v quy cch ng gi, tiu chun
cht lng (tham chiu), tn (cc) ch tiu/yu cu k thut/kt qu, kt lun,
ch k/h, tn/con du/ngy, thng, nm pht hnh phiu.
e) H s, ti liu khc: S tay kim nghim vin, h s phn tch, s
giao/nhn mu, s theo di ha cht, thuc th, cht chun, dung dch chun ,
h s v kim nh/hiu chun thit b/dng c phn tch/kim nghim....
11.9. Quy trnh sn xut
a) Quy trnh sn xut bao gm cng thc gc (thnh phn, tiu chun, s
lng ca cc nguyn, ph liu u vo), bn m t chi tit ni dung cc bc
thc hin, cc thng s vn hnh thit b sn xut (nu c) v nhng yu cu
20

kim tra, gim st i vi cc thng s/thao tc trng yu trong qu trnh sn

xut.
b) C s cn thm nh quy trnh sn xut cung cp chng c bng h s
rng khi c sn xut theo quy trnh th cc l sn phm u t tiu chun
cht lng v ng nht. Mi s thay i trong quy trnh (nu c) cn c cn
nhc, xem xt mc nh hng n cht lng ca sn phm.
11.10. H s l sn phm
a) H s l sn phm l ton b h s, ti liu c lin quan n vic sn xut
mt l thnh phm, th hin lch s mi l sn phm v cung cp thng tin lin
quan n cht lng l sn phm .
b) B h s l sn phm gm cc thnh phn c bn sau:
- Lnh sn xut kim phiu xut nguyn ph liu;
- Nhn chp nhn (QA passed), phiu kim nghim/kim sot ca cc nguyn
liu chnh, nhn cc nguyn, ph liu sau cn v phiu cn (nu c);
- Nhn tnh trng sch phng, thit b sn xut v phiu kim tra dn quang
dy chuyn trc khi sn xut;
- Kt qu thc hin quy trnh sn xut v cc phiu/kt qu kim tra trong
qu trnh sn xut;
- Nhn chp nhn v phiu kim nghim/kim sot (nu c) ca cc sn
phm trung gian, bn thnh phm;
- Phiu kim nghim thnh phm;
- Lnh xut xng.
11.11. Mt s h s, ti liu khc:
- H s v nhn s (bn m t trch nhim, quyn hn cc cn b ch cht,
m t cng vic cc nhm nhn vin, h s o to, h s khm sc khe);
- Quy trnh v kt qu nh gi cc thit b sn xut, thit b kim nghim,
thit b ph tr v h thng tin tch lin quan.
- Nht k s dng cc thit b sn xut/kim nghim;
- cng v kt qu thm nh khu vc sn xut, kim nghim v bo
qun;
- H s theo di iu kin sn xut (nhit, m , cp sch);
- cng v kt qu thm nh quy trnh sn xut;
- H s bo qun, lu thng, phn phi sn phm;
- H s v nh gi nh cung cp, sn xut/kim nghim theo hp ng, gii
quyt khiu ni, thu hi sn phm;
- H s v an ton lao ng, phng chy cha chy v bo v mi trng;
21

- H s t thanh tra.
12. Sn xut v kim nghim theo hp ng
12.1. Vic sn xut v kim nghim theo hp ng cn phi c xc nh r
rng, thng nht v c kim sot trnh hiu lm nh hng n cng vic v
cht lng sn phm.
12.2. Vic sn xut, kim nghim theo hp ng cn phi hn ch trong phm
vi sn xut gia cng mt vi cng on nht nh hay kim tra cht lng mt s
ch tiu c th (khng bao gm cc ch tiu c bn quy nh ti 9.1, Ph lc 1),
khi m bn giao hp ng thc s khng iu kin u t v/hoc thc hin
t. Trnh lm dng vic sn xut, kim nghim theo hp ng.
12.3. Bn nhn hp ng phi c nh xng, thit b, kin thc, kinh
nghim v nhn lc ti thiu p ng cc nguyn tc, tiu chun GMP bao b
dc phm mi c thc hin sn xut hay kim nghim theo hp ng
(nhng cng vic trong phm vi nng lc ca mnh).
12.4 Bn giao hp ng chu trch nhim nh gi nng lc bn nhn hp
ng m bo nguyn tc GMP bao b dc phm c tun th. H s nh
gi phi c lu tr v cung cp cho c quan c thm quyn khi c yu cu.
12.5. Bn nhn hp ng khng c chuyn cho bn th ba cng vic
c giao khi cha c bn giao hp ng nh gi v chp nhn.
12.6. Cn xy dng bn hp ng gia bn giao hp ng v bn nhn hp
ng trong nu r trch nhim c th ca mi bn, chng hn trch nhim ly
mu, kim nghim, kim tra trong qu trnh sn xut, quyt nh chp nhn hay
loi b nguyn liu, quyt nh c php chuyn tip cng on sn xut.
12.7. Hp ng cn phi ch r cch thc ngi c y quyn thc hin y
trch nhim ca mnh i vi vic ph duyt xut xng thnh phm.
12.8. Hp ng cn quy nh bn giao c quyn kim tra, gim st s tun
th ca bn nhn; bn nhn sn sng to iu kin cho cc hot ng kim tra.
12.9. Bn giao hp ng phi cung cp cc thng tin cn thit thc hin
cc iu khon trong hp ng v m bo cc vn c th gy hi nh xng,
thit b, nhn vin v sn phm c bn nhn hp ng nhn thc y .
12.10. Nhng quy trnh p dng trong nh my ca bn nhn phi ph hp
vi cc quy trnh p dng trong nh my ca bn giao.
12.11. H s sn xut, kim nghim v mu lu phi c sn bn giao hp
ng phc v cho vic nh gi cht lng, gii quyt khiu ni sn phm v
cung cp cho thanh tra khi cn thit.
13. X l khiu ni, thu hi sn phm v x l sn phm b tr v
13.1. Nguyn tc chung
a) Phi p dng quy trnh chnh thc kim tra cc khiu ni sn phm
nhn c v nhng thng tin v sn phm khng t hoc c nghi ng v cht
22

lng khc.
b) Nu cn thu hi sn phm th cn tin hnh vic ny tht nhanh chng,
hiu qu.
c) Phi ch nh ngi ph trch v c nhm nhn vin chu trch nhi m v
vi c x l khiu ni, thu hi v x l sn phm thu hi v.
13.2. Khiu ni sn phm
a) Nu pht hin hay nghi ng c sn phm khng t tiu chun cht lng
th cn tin hnh xem xt, nh gi cc yu t nh hng, nu cn th xem xt
thm cc l khc c lin quan.
b) Cn phi phn tch nguyn nhn cc trng hp sn phm b khiu ni
a ra cc bin php khc phc hay phng trnh.
c) Phi c h s lu kt qu x l khiu ni sn phm; ghi r l sn xut c
lin quan v bin php x l tng ng.
13.3. Thu hi sn phm
a) Phi c quy trnh chnh thc quy nh v vi c thu hi sn phm v t
chc c h thng c kh nng thu hi nhanh, c hi u qu i vi cc sn
phm km cht lng.
b) Vi c thu hi sn phm phi c tin hnh cng sm cng tt n tt c
cc c s phn phi, s dng nhng sn phm km cht lng. Bi t tr nhng
sn phm thu hi v ti ni ph hp trong khi ch quyt nh x l.
c) Phi theo di qu trnh thu hi sn phm v l p thnh h s; bo co cui
cng phi cho bit s lng sn phm phn phi v s lng thu hi c.
14. T thanh tra
14.1. Mc ch ca hot ng t thanh tra l nh sn xut bao b nh gi
s tun th cc nguyn tc, tiu chun GMP bao b dc phm trong cc hot
ng sn xut v kim tra cht lng, pht hin khim khuyt v ra chng
trnh hnh ng v bin php khc phc ph hp.
14.2. C s cn thnh lp Ban t thanh tra. Cc thnh vin ca Ban t thanh
tra l nhng ngi c trnh , nng lc nh gi y , khch quan vi c
trin khai, p dng cc nguyn tc, tiu chun GMP bao b dc phm, l trng
cc b phn c lin quan ca nh my. C s c th mi chuyn gia bn ngoi.
14.3. Cc c s sn xut bao b tip xc trc tip vi thuc cn c danh mc
kim tra (Ph lc 3) xy dng danh mc t thanh tra p ng yu cu theo
cc nguyn tc, tiu chun GMP bao b dc phm v ph hp vi thc t trin
khai ti c s. Danh mc ny cn c nh k r sot, cp nht.
14.4. Vic t thanh tra cn c tin hnh nh k t nht mi nm mt ln v
t thanh tra trong mt s trng hp c bit nh khi sn phm lin tip khng
t cht lng, khi c khiu ni v sn phm hoc khi nhn c k hoch thanh
kim tra ca c quan chc nng.
23

14.5. Sau mi t t thanh tra cn phi c bo co kt qu t thanh tra, nh

gi, phn loi mc khim khuyt; ra bin php, k hoch khc phc; tin
hnh khc phc, theo di v nh gi mc hon thnh.
14.6. Ty thuc ni dung, tnh cht ca t t thanh tra, phm vi thc hin c
th ton b hay mt s phn trong cc lnh vc chnh sau y:
a) Nhn s v o to;
b) Nh xng v h thng ph tr;
c) Bo tr, bo dng nh xng, thit b;
d) V sinh nh xng, thit b v v sinh c nhn;
) Nguyn liu v nh gi nh cung cp;
e) Sn xut v kim tra trong qu trnh sn xut;
g) Nhn v ghi nhn;
h) Hot ng kim tra cht lng v cng tc tiu chun ha;
i) Hiu chun, kim nh thit b v dng c o;
k) Cng tc bo qun, lu thng, phn phi, khiu ni, thu hi sn phm;
l) nh gi hot ng sn v kim nghim theo hp ng;
m) An ton lao ng, bo v mi trng.
15. An ton lao ng, phng chy cha chy v bo v mi trng
C s sn xut bao b tip xc trc tip vi thuc phi tun th cc quy nh
php lut v cng tc phng chy cha chy, an ton lao ng v bo v mi
trng.
KT. B TRNG
TH TRNG

( k)

Cao Minh Quang

24

PH LC 2
KHI NIM V PHN LOI CP SCH THEO GMP
(Km theo Thng t s 14/2012/TT-BYT ngy 31 /8/ 2012 ca B Y t)
Khu vc sch l nhng khu vc c kim sot v gii hn tiu phn l v vi
sinh vt trong khng kh v b mt thit b sn xut, sn, tng, trn phng sn
xut. Khu vc ny phi c thit k, xy dng nhm gim thiu cc nguy c
gy nhim, nhim cho v duy tr cp sch.
Cp sch ca cc phng sn xut cn c thit lp cho ph hp vi dy
chuyn sn xut cc loi sn phm nh bao b ng gi thuc v trng, thuc
ung hay thuc dng ngoi khng c vt thng h; bao b phi lm sch
(ra, hp, sy, lm kh, ...) trc khi dng hay c s dng ngay. Cp sch
phng sn xut phi ph hp vi mc gy nhim n sn phm ti ni din
ra thao tc sn xut nh cc phng cp pht nguyn liu, phng pha ch (khi sn
phm ang trong tnh trng h, tip xc trc tip vi mi trng khng kh),
hoc n giai on bao gi, bo qun....
Cc thng s nh s ln trao i khng kh/n v thi gian, chnh lch p
sut gia cc phng/hnh lang/phng c thit lp cng vi cc bin php khc
m bo duy tr cp sch.
Nhng thng s nh nhit , m, nh sng cn c thit lp, duy tr
theo quy nh GMP-WHO v ph hp vi c tnh sn phm (chu nhit, m),
mc pht sinh bi v iu kin lm vic ca nhn vin.
Cp sch

+ 0,5 (m)

3.520

3.520

+ 5,0 (m)

20

29

S lng tiu phn c

trong 1 m3 khng kh:
- Lc ngng ngh:
352.000 3.520.000
2.900

29.000

- Lc hot ng:
+ 0,5 - 5,0 (m)

3.520

352.000 3.520.000

+ Trn 5,0 (m)

20

2.900

29.000

- cfu/m3 (1)

<1

10

100

200

- cfu/a/4 gi (2)

<1

50

100

- cfu/a tip xc (3)

<1

25

50

- cfu/gng tay (4)

<1

25

25

25

Gii hn vi sinh vt:

Nhit

25
25

Cp sch

70 %

70 %

70 %

70 %

p sut (tuyt i) &

bin (pascal)

28 5

18 4

10 3

42

(14 - 22)

(7 - 13)

(2 - 6)

Trao i khng kh
(ln/gi)

(4,5 m/s)

20

15 - 20

10 - 15

(23 - 33)
20

(1): Phng php ly mu khng kh;

(2): Phng php t a thch ng knh 90 mm trong 4 gi;
(3): Phng php a thch tip xc ng knh 55 mm;
(4): Phng php in 5 ngn gng tay;
KT. B TRNG
TH TRNG

( k)

Cao Minh Quang

26

PH LC 3
DANH MC KIM TRA GMP BAO B DC PHM
(Km theo Thng t s 14/2012/TT-BYT ngy 31 /8/ 2012 ca B Y t)
Cch ghi kt qu (ty theo cu hi):

Stt

(1)

- Khng c/ Khng t

- C khng y / Cha t

- C/ t

- in vo ch trng (Ghi ch)

(th d: Cp C)

Ni dung

(2)

Tham
chiu

Khng
t

(3)

(4.1)

(4.2)

1.

H thng qun l cht lng

a.

C s c thit lp c h thng qun

l cht lng bao gm cc quy trnh,
ngun lc v c cu t chc c lin
quan hay khng.

2.1

b.

B phn sn xut v b phn qun l

cht lng c lp c vi nhau hay
khng.

2.4

c.

Trng b phn m bo cht lng c

kim trng b phn kim tra cht
lng hay khng.

2.4

d.

C s c thit lp v duy tr hot ng

kim tra trong qu trnh sn xut
khng.

2.5

C s c tin hnh kim tra gim st

ln nhau gia cc b phn thng qua
vic nh gi s ph hp tiu chun
c ph duyt hay khng.

2.6

2.

Nhn s v o to

a.

Tng s cn b cng nhn vin.

3.1

b.

Trong : i hc (dc/khc); Cao

ng, trung cp (dc/khc); S cp

3.1

Khng
c

Ghi
ch

(5)

(6)

2.2
2.3

27

(1)

(2)

(3)

(4.1)

(4.2)

(5)

(6)

dc/khc); Lao ng ph thng.

c.

Trong : Phng m bo cht lng/

Phng Kim tra cht lng/ Xng sn
xut/ Cc b phn khc (kho, c
in, ...).

d.

Hng nm c tin hnh khm sc khe

cho cn b nhn vin hay khng.

C bn m t cng vic ca tng nhm

nhn vin hay khng.

3.1

e.

C bn m t nhim v v quyn hn
ca trng b phn qun l sn xut

3.2

g.

C bn m t nhim v v quyn hn
ca trng b phn m bo cht lng

3.3

h.

C bn m t nhim v v quyn hn
ca trng phng kim tra cht lng

3.4

i.

C s c xy dng k hoch, chng

trnh, ni dung o to, bao gm o
to bn ngoi, ph hp vi cc i
tng lin quan hay khng.

3.5

k.

Lit k cc ni dung o to theo

chuyn ti c s.

3.5

l.

Ngi o to c kin thc, kinh

nghim v c o to v GMP hay
khng.

3.5

m. Sau mi t o to c c nh gi
kt qu v lu li y h s hay
khng.

3.5

3.

Nh xng

a.

Nh xng c c thit k v xy
dng p ng yu cu phng chng
bo lt, cn trng xm nhp v cch ly
cc ngun ly nhim.

4.1

b.

Nh v sinh (i tin) c c b tr
tch bit khi khu vc sn xut

4.2

c.

Khu vc sn xut bao b c c b tr

bit lp vi khu vc sn xut cc loi

4.2

28

(1)

(2)

(3)

(4.1)

(4.2)

(5)

(6)

sn phm khc v ph hp vi cc khu

vc khc nh kho nguyn liu ban u,
khu vc bo qun vt liu bao gi, kho
thnh phm hay khng.
d.

e.

Cc phng sn xut c c b tr theo

nguyn tc mt chiu v c khng gian
rng hay khng.

4.3

Cp sch cc phng sn xut c c

thit k, xy dng ph hp vi cc
dng sn phm v cng on sn xut
hay khng.

4.6

C cc bin php m bo duy tr

cp sch v iu kin sn xut ph hp
nh chnh p, trao i khng kh,... hay
khng.

4.9

4.4

4.7
4.8
4.10

g.

Cc khu vc bo qun c p ng c
iu kin v ph hp vi i tng bo
qun hay khng.

4.12

h.

C tin hnh nh gi tng th nh

xng trc khi a vo s dng v
nh k thc hin vic nh gi li v
lu li h s hay khng.

4.15

4.

Thit b

a.

C s c trang b cc thit b p ng
yu cu sn xut, kim nghim hay
khng.

5.1
5.2

b.

C xy dng cc cng v tin hnh

nh gi thit b trc khi a vo s
dng hay khng.

5.3
5.4
5.5

c.

Cc thit b c c nh k bo tr,
bo dng, nh gi li v gn nhn
tnh trng ph hp khng.

5.5

d.

C tin hnh kim nh, hiu chun i

vi cn, p k v nhng thit b o
lng khc hay khng.

5.6

C cc phng tin vn chuyn hng

ha, sn phm ph hp khng.

5.7

29

(1)

(2)

(3)

5.

V sinh v iu kin v sinh

a.

C s c chng trnh v sinh tng th

nh xng v bin php phng chng
nhim, nhim cho hay khng.

6.1

b.

C quy nh v vic ra vo khu vc

sn xut i vi ngi khng c phn
s, nhn vin mc bnh hay khch
tham quan hay khng.

6.2

c.

C du hiu phn bit trang phc bo

h lao ng, giy dp dng trong nh
my i vi cc nhm nhn vin ng
gi, nhn vin thao tc trong vng c
kim sot cp sch v qun o ln 1
mc bn ngoi khng.

6.2

d.

Cc SOP v sinh c nhn v thit b

sn xut c c thm nh/nh gi
v lu li h s hay khng.

6.1

Nhn vin c ra, sy tay ngay sau khi

v sinh v trc khi mc trang phc
bo h hay khng.

6.1

e.

C nhn tnh trng (v sinh sch) i

vi thit b, dng c sn xut hay qun
o bo h lao ng khng.

6.1

g.

C phng lm v sinh, phng bo qun

ring cho nhng dng c sn xut, ph
kin tho ri hay khng.

6.3

h.

Nc trng ln cui cc thit b, dng

sch l nc g.

6.3

i.

Kh nn c c nh gi v nhim
bi vt l v vi sinh khng.

6.3

k.

nh k c tin hnh thanh, tit trng

cc phng sn xut (bao gm h thng
cp kh) hay khng.

6.4

l.

C s c quy nh v vic thu gom rc

thi, v sinh mi trng v lm v sinh
i vi cc khu vc chung nh hnh
lang, pass-box,... hay khng.

6.4

(4.1)

(4.2)

(5)

(6)

30

(1)

(2)

(3)

6.

Nguyn vt liu

a.

Lit k mt s nguyn liu u vo

chnh c s dng ti c s.

b.

C s dng loi nc dng trong sn

xut bao b.

7.4

c.

Tm tt phng php, tn sut nh

gi cht lng nc u vo.

7.4

d.

C s c xy dng tiu chun cht

lng ca cc nguyn vt liu s dng
trong nh my khng.

7.1

Tiu chun cht lng nguyn liu ban

u c ph hp vi tiu chun cht
lng v mc ch s dng ca thnh
phm hay khng.

11.8

e.

Tiu chun cht lng ca nguyn liu

v thnh phm ph hp vi Dc in
no, chuyn lun g.

11.8

g.

C quy trnh nh gi nh cung cp, v

tin hnh nh gi, lu li h s hay
khng.

7.3

h.

Nguyn liu nhn v c c bit tr

(gn nhn vng) trong thi gian ch ly
mu kim nghim, nh gi xem th c
chp nhn s dng hay khng.

7.1

i.

Nu iu kin bo qun nguyn liu

ban u.

4.12

k.

Vic xem xt chp nhn c c thc

hin cho mi l, ln nhp hng v c
ngi c thm quyn ph duyt hay
khng.

7.1

l.

Lit k nhng tiu ch, php th c s

cha kim nghim c.

7.5

m. C s p dng bin php g trong

vic kim sot, nh gi cht lng i
vi nhng tiu ch, php th phng
kim nghim c s cha lm c.

7.5

n.

7.5

C lu gi cc phiu kim nghim gc

(4.1)

(4.2)

(5)

(6)

31

(1)

(2)

(3)

(4.1)

(4.2)

(5)

(6)

ca nguyn liu ban u hay khng.

o.

C s c s dng mc in bao b hay

khng. Nu r loi mc.

7.8

p.

C sn h s chng minh tnh an ton

loi mc hay khng.

7.8

7.

Sn xut

a.

S lng, trnh v kinh nghim ca

ngi qun l phn xng, cc t
trng v nhn vin sn xut c p
ng yu cu hay khng.

8.1

b.

Lit k tm tt nhn s tham gia sn

xut trc tip.

8.1

c.

Cc cng on sn xut c c b tr
ti khu vc c cp sch ph hp v
m bo nguyn tc mt chiu hay
khng.

4.3
8.2

d.

Nguyn liu ban u c c ngi c

thm quyn cho php, c gn nhn
chp nhn (nhn xanh) trc khi a
vo s dng khng.

8.3

Phng sn xut v thit b c c lm

v sinh sch, m bo trong tnh trng
vn hnh tt trc mi ca sn xut
khng.

8.3

e.

C quy trnh sn xut c ph

duyt cho mi sn phm khng.

8.4

g.

S quy trnh sn xut c thm nh /

tng s c ban hnh.

10.4

h.

C ghi chp kt qu thc hin kp thi

vo h s l hay khng.

8.4

i.

C s c t chc hot ng kim tra

trong qu trnh m bo thc hin
ng quy trnh sn xut v tun th
nguyn tc GMP hay khng.

8.6

k.

S lng nhn vin IPC / thuc b

phn no.

2.5
8.6

32

(1)

(2)

(3)

C SOP m t nhim v nhn vin IPC

v nu r tn sut thc hin cho mi
hot ng c th hay khng.

2.5

m. C cc SOP vn hnh, v sinh thit b

sn xut hay khng.

5.4
6.3

n.

Sn phm sau mi cng on chnh c

c bit tr ch kt qu kim nghim
v/hoc kin ngi c thm quyn
trc khi c php sn xut tip hay
khng.

8.6

o.

Ai l ngi c thm quyn cho php

xut xng thnh phm. Cn c
xut xng c bao gm vic xem xt
h s l, kt qu kim tra trong qu
trnh, cc phiu kim nghim v cc
yu t lin quan khc hay khng.

8.6

p.

C s nht k ghi chp vic s dng v

lm v sinh i vi nhng thit b sn
xut chnh hay khng.

5.4

q.

C SOP quy nh vic thu gom, bit

tr, x l d/ph phm v h s ghi
chp kt qu thc hin hay khng.

8.7

8.

Kim tra cht lng

a.

C s c phng kim nghim kim

tra cht lng nguyn liu u vo, sn
phm trung gian, thnh phm v nh
gi mi trng sn xut khng?

9.1

b.

S lng, trnh v kinh nghim ca

trng phng, cc t trng v nhn
vin phng kim nghim c p ng
yu cu hay khng.

9.1

c.

Lit k tm tt nhn s phng kim

nghim.

9.1

d.

C phng kim nghim vi sinh vt p

ng yu cu v cp sch nh gi
mi trng sn xut v kim tra
nhim khun sn phm hay khng.

9.1

C cc thit b kim nghim p ng

9.1

l.

(4.1)

(4.2)

(5)

(6)

33

(1)

(2)

(3)

(4.1)

(4.2)

(5)

(6)

yu cu kim tra cht lng nguyn

liu v sn phm hay khng.
e.

Cc thit b c c bo tr/bo dng,

kim nh/hiu chun hay khng.

9.1
5.6

g.

Lit k cc thit b kim nghim hin

c ti c s.

9.1

h.

C cc quy trnh kim nghim c

ph duyt hay khng.

9.1

i.

Nhng php th no c s cha thc

hin c.

9.3
7.2

k.

Nu mt s cn c chp nhn s ph
hp tiu chun ca nguyn liu ban u
trong trng hp c mt s tiu ch m
phng th nghim ca c s khng th
nghim c.

7.2
7.4

l.

Vic ly mu nguyn liu c thc

hin ti ni no.

9.2

m. S lng, thi gian v iu kin lu

mu, bao gm mu thnh phm, c p
ng yu cu theo di cht lng v gii
quyt khiu ni hay khng.

9.2

n.

C s c tin hnh nghin cu n

nh, xc nh tui th cc sn phm
sn xut ti nh my khng.

9.4

o.

Nu hn s dng v iu kin bo qun

tng ng cc sn phm ca c s.

9.4

p.

Nu iu kin bo qun thnh phm

trong qu trnh lu kho v trong qu
trnh vn chuyn

9.4
4.12

9.

Thm nh

a.

C s c k hoch thm nh gc hay

khng.

10.1

b.

K hoch thm nh gc c quy nh

cc ni dung c bn cn phi thc hin.

10.1

c.

C s c thnh lp ban thm nh, nhn

s ph hp vi lnh vc thc hin hay

10.2

34

(1)

(2)

(3)

d.

Lit k cc ni dung m c s thm

nh, nh gi.

10.5

C cng cho tit i vi mi ni

dung cn thm nh trong nu r
phng php thc hin, thit b s
dng, nhn s tham gia, tiu chun
chp nhn, thi gian ti thm nh, ...
khng.

10.3

e.

Vic thm nh c c thc hin theo

ng k hoch v cng; c bo co
y v lu li h s hay khng.

10.3

(4.1)

(4.2)

(5)

(6)

khng.

10. Ti liu v h s
a.

C quy trnh thao tc chun quy nh

vic xy dng, ban hnh, qun l cc
h s s ti liu v cc SOP khng.

11.3

b.

C quy nh vic truy cp, sa cha,

lu tr h s, ti liu bng h thng
my tnh.

11.4

c.

C xy dng cc quy trnh thao tc

chun hng dn vic thc hin nhng
thao tc khng.

11.6

d.

H s, ti liu v kim tra cht lng

ti thiu c:
- Tiu chun cht lng (yu cu,
phng php th) nguyn liu, thnh
phm, bn thnh phm;

11.8

- H s kim nghim (s tay kim

nghim vin, phiu phn tch, phiu
kim nghim);
- Nht k s dng cc thit b phn tch
chnh

11.11

- H s v kim nh/hiu chun thit

b/dng c phn tch/kim nghim,;

11.8

- S theo di ha cht, thuc th, cht

chun, dung dch chun ; giao, nhn
mu;

11.8

35

(1)

(2)

H s, ti liu lin quan n sn xut

ti thiu c bao gm:

e.

(3)

- Quy trnh sn xut (gc) cho mi sn

phm.

11.9

- H s l sn phm.

11.10

- cng thm nh v h s thm

nh tng quy trnh sn xut.

11.9
11.11

- Nht k vn hnh cc thit b sn xut

chnh v theo di iu kin sn xut

11.11

(4.1)

(4.2)

(5)

(6)

C s c thit lp, thc hin v lu gi

cc h s, ti liu khc nh:
- H thng nhn.

11.7

- H s nh gi thit b/mi trng

sn xut/kim nghim/bo qun;

11.11

- H s v bo qun, lu thng, gii

quyt khiu ni, thu hi sn xut;

11.11

- H s v nh gi nh cung cp, sn
xut/kim nghim theo hp ng;

11.11

- H s nhn s;

11.11

- H s v an ton lao ng, phng

chy cha chy v bo v mi trng

11.11

- H s t thanh tra

11.11

11. Sn xut v kim nghim theo hp

ng
a.

C c c thc hin vic sn xut hay

kim nghim theo hp ng hay khng.
Nu c th ni dung.

12.2

b.

C tin hnh nh gi bn nhn hp

ng v vic p ng cc nguyn tc,
tiu chun GMP bao b dc phm v
lyu li h s hay khng.

12.4

c.

Hp ng c nu c th trch nhim
mi bn hay khng.

12.6

12. X l khiu ni, thu hi sn phm v

x l sn phm b tr v
36

(1)

(2)

(3)

a.

C quy trnh quy nh vic tip nhn,

x l thng tin khiu ni sn phm, thu
hi sn phm v x l sn phm b tr
v khng.

13.1
13.3

b.

C thnh lp ban x l khiu ni, thu

hi sn phm.

13.1

c.

C lu h s v x l khiu ni, thu hi

sn phm.

13.2
13.3

(4.1)

(4.2)

(5)

(6)

13. T thanh tra

a.

C quyt nh thnh lp ban t thanh

tra bao gm b phn qun l cht lng
v i din cc b phn c lin quan
hay khng.

14.2

b.

C xy dng danh mc t thanh tra ph

hp vi thc t ca c s hay khng.

14.3

c.

Nu tn sut t thanh tra ti c s.

14.4

d.

Sau mi t t thanh tra c bo co,

phn loi khim khuyt, tin hnh khc
phc v nh gi hnh ng khc phc
khng.

14.5

14. An ton lao ng, phng chy cha

chy v bo v mi trng
a.

An ton lao ng:

15

- Cc khu vc sn xut, kim nghim

v bo qun c c kim sot v
n, nh sng v cc tc ng khc n
sc khe nhn vin.
- Cc thit b c nguy c nh hng
n sc khe nh l hi, kh nn, ...
c c kim nh khng.
- Nhn vin c c o to v an ton
lao ng.
b.

Phng chy, cha chy:

15

- Trong xng v kho c ni quy phng

v cha chy.
- Cc b phn c y cc thit b
37

(1)

(2)

(3)

(4.1)

(4.2)

(5)

(6)

phng v cha chy.

- Tt c nhn vin c o to v
phng v cha chy.
- C h s kim tra ca c quan chc
nng v cng tc phng chy cha
chy.
c.

Bo v mi trng:

15

- C h thng hay bin php thu gom,

x l kh thi pht sinh trong qu
trnh sn xut/kim nghim/bo
qun/khc hay khng.
- C h thng hay bin php thu gom,
x l cht thi rn pht sinh trong qu
trnh sn xut/kim nghim/bo
qun/khc hay khng.
- C h thng thu gom, x l cht thi
lng pht sinh trong qu trnh sn
xut/kim nghim/bo qun/khc hay
khng.
- C ti liu hng dn v h s v
cng tc bo v mi trng.
- C ti liu tp hun v h s o to
cho cn b/nhn vin lin quan v
cng tc bo v mi trng.
- C h s t kim tra nh k ca c
s v cng tc bo v mi trng.
- C h s kim tra ca c quan chc
nng v cng tc bo v mi trng.
KT. B TRNG
TH TRNG

( k)

Cao Minh Quang

38

PH LC 4
MU BN NG K KIM TRA
(Km theo Thng t s 14/2012/TT-BYT ngy 31 /8/ 2012 ca B Y t)
Mu 1 - Bn ng k kim tra
N V CH QUN

CNG HA X HI CH NGHA VIT NAM

TN C S

c lp - T do - Hnh phc

S: ./..

........., ngy...... thng...... nm 20........

BN NG K KIM TRA
THC HNH TT SN XUT BAO B DC PHM
Knh gi: Cc Qun l dc - B Y t
Tn c s:
a ch cng ty/nh my sn xut:
in thoi/Fax/E-Mail:
Thc hin Thng t s 14/2012/TT-BYT ngy 31/8/2012 ca B Y t quy
nh cc nguyn tc, tiu chun Thc hnh tt sn xut bao b dc phm v
hng dn vic trin khai, p dng, sau khi tin hnh t thanh tra v nh gi
t yu cu; c s chng ti xin ng k vi B Y t (Cc Qun l dc) kim
tra GMP bao b dc phm i vi dy chuyn sn xut cc dng bao b ng
gi dc phm sau: ..
Chng ti xin gi km bn ng k ny cc ti liu sau y:
a) Bn sao Quyt nh thnh lp c s (hoc Giy chng nhn ng k
kinh doanh hoc Giy chng nhn u t) c xc nhn ca c s;
b) S t chc nhn s;
c) Ti liu, h s v hun luyn, o to;
d) S nh xng;
) Danh mc thit b hin c v sn phm d kin c sn xut;
e) Kt qu t thanh tra.
Ph trch c s
(K, ghi r h tn, ng du)

39

Mu 2 - Bn ng k ti kim tra
N V CH QUN

CNG HA X HI CH NGHA VIT NAM

TN C S

c lp - T do - Hnh phc

S: ./..

........., ngy...... thng...... nm 20........

BN NG K TI KIM TRA
THC HNH TT SN XUT BAO B DC PHM
Knh gi: Cc Qun l dc - B Y t
Tn c s:
a ch cng ty/nh my sn xut:
in thoi/Fax/E-Mail:
C s chng ti c B Y t (Cc Qun l dc) cp Giy chng nhn
GMP bao b dc phm theo Quyt nh s ..........., ngy ..../...../....., ti ...........
i vi nhng dy chuyn sn xut cc dng bao b tip xc trc tip vi thuc.
Sau khi tin hnh t thanh tra v nh gi t yu cu, chng ti xin ng k vi
B Y t (Cc Qun l dc) ti kim tra GMP bao b dc phm i vi dy
chuyn sn xut cc dng bao b tip xc trc tip vi thuc nu trn.
Chng ti xin gi km bn ng k ny cc ti liu sau y:
a) Bo co khc phc cc tn ti trong kim tra ln trc;
b) Bo co tm tt hot ng ca c s trong 03 nm qua;
c) Bo co nhng thay i ca c s trong 03 nm qua.
d) Kt qu t thanh tra.
Ph trch c s
(K, ghi r h tn, ng du)

40