B y t

Cng ho x hi ch ngha vit nam

Cc qun l dc vit nam
c lp T do Hnh phc

S 2313/QLD-CL

H Ni, ngy 11 thng 5 nm 2007

V/v: ban hnh danh mc kim tra

GPP. GDP v mt s mu quy trnh.

Knh gi: S Y t tnh, thnh ph trc thuc Trung ng

thc hin Quyt nh s 11/2007/Q-BYT ngy 24/1/2007 ca B
trng B Y t v vic trin khai p dng nguyn tc Thc hnh tt nh thuc
(GPP) v Quyt nh s 12/2007/Q-BYT ngy 24/1/2007 ca B trng B Y
t v vic trin khai p dng nguyn tc Thc hnh tt phn phi thuc (GDP);
1. Cc Qun l Dc Vit Nam ban hnh Danh mc kim tra GPP v GDP
v mt s mu quy trnh: quy trnh cp giy chng nhn GPP, GDP.
2. Cc Qun l Dc Vit Nam ngh Gim c S Y t tnh, thnh ph
trc thuc Trung ng, Th trng Y t ngnh, Tng gim c Tng cng ty
Dc Vit Nam ph bin hng dn cho cc n v trc thuc thc hin Quyt
nh s 11/2007/Q-BYT v Quyt nh s 12/2007/Q-BYT ngy 24/1/2007
ca B Trng B Y t v bn Danh mc kim tra GPP, GDP km theo cng vn
ny.
S Y t tnh, thnh ph trc thuc Trung ng tin hnh kim tra cc n
v theo cc qui nh ti cc bn nguyn tc nh km Quyt nh ca B trng
B Y t, cc bn Danh mc kim tra kim tra, nh gi cp chng nhn
Thc hnh tt nh thuc, Thc hnh tt phn phi thuc.
3. S y t tnh, thnh ph trc thuc Trung ng p dng ng b mu quy
trnh ban hnh theo cng vn ny xy dng, ban hnh cc quy trnh kim tra
ph hp vi thc t v hng dn cc c s tham kho mu quy trnh xy
dng quy trnh thao tc cho cc hot ng ca c s.
Danh mc kim tra GPP, GDP v Quy trnh cp giy chng nhn GPP,
GDP c chuyn trn website: http://dav.gov.vn ca Cc Qun l Dc Vit
Nam.
Cc Qun l Dc Vit Nam thng bo cc n v bit v thc hin.
Ni nhn:
- Nh trn;
- TS. Trn Th Trung Chin-BT ( bo co);
- Vn phng, Thanh tra v cc V, Cc B Y t
( phi hp);
- Cc n v trc thuc B Y t;
- Vin KN thuc TW, Vin KN thuc Tp HCM;
- Cc Qun Y - B Quc phng;
- Cc Y t - B Cng an;
- S Y t- B GTVT;
- Tng Cng ty Dc VN;
- Lu QLD (02bn).

Danh mc kim tra Thc hnh tt nh thuc

( Ban hnh km theo cng vn s 2313/QLD-CL ngy 11 thng 5 nm 2007
ca Cc trng Cc Qun l dc Vit Nam)

STT
1
2
3

Ni dung
Tn c s:
a ch:
S in thoi:
Fax:
Tn ch c s/ ngi qun l hot ng chuyn mn
Giy chng nhn iu kin kinh doanh thuc:
Loi hnh ng k kinh doanh:
- H c th:
- a im bn l ca doanh nghip
- a im bn l ca c s KCB

TT

Ni dung

Email:

Tham
chiu

C
t

1
I

Nhn s

1.1.5

Ch c s (hoc ngi ph trch

chuyn mn)
C mt khi c s bn l hot ng
hoc thc hin u quyn theo quy
nh?
C trc tip tham gia bn thuc phi
k n?
C kim sot cht lng thuc khi
nhp v v trong qu trnh bo qun
ti nh thuc?
C thng xuyn cp nht kin thc
chuyn mn (tham gia cc lp tp
hun, bi dng chuyn mn....)?
C o to hng dn nhn vin?

1.1.6

C theo di cc tc dng khng III.4b

1.1.7

mong mun v thng bo vi c

quan y t ?
III.4b
C cng tc vi y t c s ?

1.1
1.1.1

1.1.2
1.1.3

1.1.4

III.4b

III.4b
III.4b

III.4b

III.4b

Khng
t
5

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

1.1.8
1.2
1.2.1

1.2.2

1.2.3
1.2.4

1.2.5
1.2.6

Thc hin vic nim yt gi thuc v

bn theo gi nim yt?.
Ngi bn l

III.4b
(0 c)

C nhn vin phc v cho hot I.2

ng ca nh thuc?
S lng nhn vin:
Dc s i hc:.........
Dc s trung hc:.........
Dc t:......
Cc bng cp khc:
Bng cp chuyn mn v thi gian I.1.3
thc hnh ngh nghip ph hp vi
cng vic c giao?
Cc nhn vin c sc kho
m ng cng vic khng? C
nhn vin no ang mc bnh truyn
nhim ?
C xc nhn ca chnh quyn a
phng trong s yu l lch?
C mc o Blu v eo bin hiu ghi
r chc danh?
C c tham gia o to, cp nht
kin thc chuyn mn v php lut y
t?
C c hun luyn hiu r v
thc hin ng cc nguyn tc GPP?
C thi ho nh, lch s khi tip
xc vi khch hng?
C gi b mt thng tin v ngi
bnh?

III.4a
III.4a

III.4a
III.4a

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

II
2.1

2.2

2.3
2.4
2.5
2.6
2.7

2.8

III
3.1

C s vt cht k thut

Xy dng v thit k
- a im c c nh, ring bit?
- B tr ni cao ro, thong mt, an
ton, cch xa ngun nhim?
- Ni bn thuc c c xy dng bng
vt liu chc chn?
- Trn nh c chng bi?
- Tng v nn nh c phng, nhn, d
v sinh, lau ra?
Din tch v b tr :
Tng din tch c s:
Din tch ph hp vi quy m kinh
doanh ( ti thiu 10m2)?
C khu vc trng by?
C khu vc bo qun thuc?
C khu vc ngi mua thuc tip
xc v trao i thng tin?
C ni ra tay? C ni ra dng c
pha ch?
Cc hot ng khc:
- Nu c t chc pha ch theo n th
c phng ring pha ch thuc?
- Nu c ra l thuc th c khu vc
ring ra l?
- Nu c kho bo qun th c t yu
cu bo qun thuc?
- C phng hoc khu vc t vn v gh
cho khch hng trong thi gian ch
i?
M phm, thc phm chc nng,
dng c y t c khu vc ring,
khng nh hng n thuc?

II.1

II.2a

II.2a
II.2a
II.2b, 2d
II.2b

II.2c

Trang thit b

Thit b bo qun thuc

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

3.1.1

3.1.2

3.2
3.2.1
3.2.2

3.2.3

3.2.4

3.2.5
3.2.6

Thit b bo qun thuc trnh c

nh hng bt li ca nh sng, nhit
, m, s nhim , s xm nhp
ca cn trng:
- C t quy bo qun thuc?
- T, quy, gi k d v sinh, m
bo thm m?
- Nhit k, m k? C ghi chp
theo di?
- Qut thng gi?
- Ni bn thuc c nh sng
m bo cc thao tc din ra
thun li v khng nhm ln?
- nh sng mt tri c chiu trc
tip vo ni trng by, bo qun
thuc?
C s c thit b bo qun p
ng vi yu cu bo qun ghi trn
nhn: C t lnh, iu ho nhit ,
my ht m?
Ni bn thuc c c duy tr nhit
phng (nhit di 30o C, m
bng hoc di 75%)?
Dng c, bao b ra l v pha ch theo
n :
C bao b ra l thuc?
Trng hp thuc khng cn bao b
tip xc trc tip th bao b c kn
kh?
Thuc dng ngoi v thuc qun l
c bit c c trong bao b d
phn bit?
Thuc bn l c ng trong bao b
mang tn thuc khc hoc cha ni
dung qung co ca mt thuc khc?
Thuc pha ch theo n ng trong
bao b dc dng?
Dng c ra l v pha ch theo n c
ph hp v d lau ra, lm v sinh?

II.3a, 3b

II.3a,
3b

II.3c
II.3c

II.3c

II.3c

II.3c
II.3

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

3.2.7
IV
4.1

4.2

5.1
5.1.1
5.1.2
5.2
5.2.1
5.2.2
5.3

C thit b tit trng cc dng c pha II.3

ch thuc theo n?
Ghi nhn thuc

Thuc bn l khng ng trong bao II.3d

b ngoi ca thuc c km theo cc
thng tin sau:
- Tn thuc, dng bo ch?
- Nng , hm lng?
Nu khng c n thuc km theo,
phi c thm thng tin:
- Cch dng?
- Liu dng?
- S ln dng?
Thuc pha ch theo n, ngoi quy II.3d
nh nh phn trn, c cc thng tin
sau:
- Ngy pha ch?
- Ngy ht hn s dng?
- Tn bnh nhn?
- Tn, a ch ni pha ch?
- Cnh bo an ton cho tr em
(nu c)?
h s s sch v ti liu chuyn mn

H s php l :
C chng ch hnh ngh dc?
C h s nhn vin?
Ti liu hng dn s dng thuc :
C ti liu hng dn s dng thuc?
C cc quy ch chuyn mn dc
hin hnh?
H s s sch lin quan hot ng
kinh doanh thuc :

I.1
I.3
II.4a
II.4a

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

5.3.1

Theo di s l, hn dng thuc v II.4b

cc vn c lin quan :
- Theo di bng my tnh?
- Theo di bng s?
- Theo di vic pha ch theo n
(nu c). C s pha ch ?
- Lu gi h s s sch t nht 1
nm k t khi thuc ht hn
dng?

5.3.2

5.3.3

5.4
5.4.1

5.4.2

C Theo di d liu lin quan n II.4b

bnh nhn khng, v d n thuc
hoc bnh nhn cn lu :
- Theo di bng my tnh?
- Theo di bng s?
H s, s sch c th tra cu kp thi
khi cn thit?
Theo di vic kinh doanh bo qun II.4b
thuc gy nghin, thuc HTT v tin
cht :
- Theo di bng my tnh?
- Theo di bng s?
Xy dng v thc hin cc quy trnh
thao tc chun :
Cc hot ng chuyn mn ti c s II.4c
c c m t v quy nh di dng
vn bn mi ngi trong c s
bn l c th c v p dng?
C cc quy trnh c bn theo yu II4.c
cu:
- Quy trnh mua thuc v kim
sot cht lng?
- Quy trnh bn thuc theo n?
- Quy trnh bn thuc khng k
n?
- Quy trnh bo qun v theo di
cht lng?
- Quy trnh gii quyt vi thuc b
khiu ni hoc thu hi?

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

5.4.3
5.4.4

5.4.5
VI
6.1

6.2

VII
7.1

7.2

Khng

Khng
t

C cc quy trnh khc? (lit k)

II.4c
Cc quy trnh thao tc chun lin Ph lc
quan n cc hot ng chuyn mn 2
ca c s c do ngi ph trch
chuyn mn ph duyt v k ban
hnh khng?
Nhn vin bn thuc c p dng thc II.4c
hin y cc quy trnh?
Ngun thuc
C h s cc nh cung ng thuc c III.1a
uy tn gm :
- Bn sao GCN iu kin hnh
ngh?
- C danh mc cc mt hng cung ng?
- Ho n hp php?
Tt c thuc mua vo c phi l thuc
c php lu hnh hp php (c SK,
hoc c s giy php nhp khu)?
Nh thuc c y cc loi thuc III.1
dng cho tuyn C trong Danh mc
thuc thit yu Vit Nam (do SYT
quy nh)?
Thc hin quy ch chuyn mn THc hnh ngh nghip
Thuc gy nghin, thuc hng tm III.4a
thn v tin cht c khu vc
ring hoc t ring?
Mua bn thuc gy nghin, thuc III.4a
hng tm thn:
- C s d tr v duyt ng quy nh?
- C mua theo quy nh?
- Trnh chuyn mn ca ngi bn?
- C bn theo n?
- C lu n bn?
- C bn theo s y b hp l?
- C ghi s bn y ?
- C ghi chp s mua bn y ?

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

7.3

7.4

7.5

7.6

Kim k nh k thuc gy nghin,

thuc hng tm thn v tin cht
theo quy nh?
- C bo co xin hu thuc qu hn,
km phm cht ?
- C bo co cp trn nh k theo quy
nh?
Kim tra i chiu s lng thuc
GN, thuc HTT, tin cht trn s
sch v thc t c khp ?
Khi bn thuc, ngi bn l c hi
ngi mua cc thng tin v triu
chng bnh, v tnh trng ngi dng
thuc trnh ri ro khi dng
thuc?
Ngi bn l c trnh chuyn mn
ph hp bn cc thuc k trong
n thuc khng?

III.4a

III.4a

III.2a

III.2c

C kim tra n thuc trc khi

bn?

7.7

Nu n thuc khng hp l, ngi

bn thuc c:
- Hi li ngi k n?
- Thng bo cho ngi mua?
- T chi bn?
Ngi bn l l dc s i hc c
thay th thuc trong n thuc bng
thuc c cng hot cht, dng bo ch,
liu lng?
Khi bn thuc, ngi bn l c t III.2
vn v thng bo cho ngi mua:
- La chn thuc ph hp nhu cu iu
tr v kh nng ti chnh?
- Cch dng thuc?
- Cc thng tin v thuc, tc dng ph,
tng tc thuc, cc cnh bo?
- Nhng trng hp cn s chn on
ca thy thuc mi dng thuc?
- Nhng trng hp khng cn s dng
thuc?

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

7.8

7.9

7.10

Hng dn s dng thuc c va III.2a

bng li ni, va ghi nhn theo quy
nh?
Khi giao thuc cho ngi mua, ngi III.2a
bn l thuc c kim tra i chiu
cc thng tin sau:
- Nhn thuc?
- Cht lng thuc bng cm quan?
- Chng loi thuc?
- S lng?
Ngi bn l, c s bn l c tin III.2b

hnh cc hot ng thng tin,

qung co thuc tri vi quy nh
v thng tin, qung co. (v d
qung co thuc k n cho cng
chng)?

7.11
7.12
7.13

VIII
8.1

Ngi bn l thuc c khuyn khch

ngi mua mua nhiu thuc hn cn
thit khng?
III.1c
Thuc c nhn?
Nhn thuc v thuc bn trong ng III.1c
v khp vi nhau?
Sp xp thuc:
III.3
- Sp xp gn gng, d ly, trnh nhm
ln?
- Sp xp theo iu kin bo qun ghi
trn nhn?
- C khu vc ring cho Thuc k
n?
Kim tra/ m bo cht lng thuc
Khi nhp thuc, ngi bn l c III. 1c
v III.1d
kim tra:
- Hn dng ca thuc?
- Thuc cn nguyn vn trong bao b
gc ca nh sn xut?
- Cc thng tin trn nhn thuc (theo
yu cu quy ch nhn), kim sot cht
lng bng cm quan khng?

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

8.2

IX
9.1

9.2
9.3
9.4
9.5
9.6
9.7

Khng

Nhn
xt

Khng
t

Trong c s c cc loi thuc sau III.1c

khng:
- Thuc khng c lu hnh?
- Thuc qu hn dng?
- Thuc khng r ngun gc sn xut
v kinh doanh ?
- Thuc gy nghin (tr nh thuc c
php bn)?
- Thuc hng tm thn? (i vi c
s khng c duyt mua)?
- Thuc b nh ch v thu hi?
Gii quyt i vi thuc b khiu ni hoc thuc phi thu hi
C tip nhn thng tin hoc lu cc III.3c
thng bo v thuc khiu ni, thuc
khng c php lu hnh, thuc
phi thu hi ?
C kim k i vi thuc khiu ni, III.3c
thuc phi thu hi?
C thng bo thu hi cho khch III.3c
hng ?
C thu hi v lp h s thu hi theo III.3c
quy nh?
III.3c
C tr li ni mua hoc hu?
III.3c
C bo co cc cp theo quy nh?
C s theo di tc dng ph ca III.3b
thuc do khch hng phn nh?
Ch thch:
- Mc Tham chiu theo cc ni dung ti Chng II Nguyn tc, tiu chun Thc hnh tt
nh thuc ban hnh km theo Quyt nh s 11/2007/Q-BYT ngy 24/01/2007 ca B
trng B Y t.
- Cc mc in nghing l nhng phn hi khi kim tra hoc kt hp gia quan st v hi khi
kim tra.
- Nhng ni dung lin quan n dch v m nh thuc khng cung cp (v d: bn thuc gy
nghin) th ngi kim tra ghi r v b qua cc ni dung ny khi nh gi.

10

U BAN NHN DN........

S Y T..........

QUY TRNH
CP GIY CHNG NHN T TIU CHUN
THC HNH TT NH THUC (GPP)
QT.QLD.GPP

Ngi vit
H v tn
K

Ngi kim tra

Ngi ph duyt

QT.QLD.GPP

M s: QT.QLD.GPP

QUY TRNH

S Y T.....

CP GIY CHNG NHN

T TIU CHUN
THC HNH TT
NH THUC (GPP)

Ngy ban hnh:

Ln sa i:
Tng s trang:

1. Ngi c lin quan phi nghin cu v thc hin ng cc ni dung

ca quy nh ny.
2. Mi phng c lin quan c phn phi 01 bn (c ng du kim

sot). File mm c cung cp trn......

NI NHN (ghi r ni nhn ri nh du X bn cnh)

THEO DI TNH TRNG SA I (tnh trng sa i so vi bn trc )

Ln sa i

Ngy sa i

Ni dung v hng mc sa i

-1Ngy p dng:

Ln sa i: 00

QT.QLD.GPP

1. Mc ch
Tiu chun ha vic xem xt cp Giy chng nhn t tiu chun GPP nhm
m bo:
- S cng khai, minh bch trong qu trnh xem xt, thm nh v cp .
- Vic xem xt, thm nh v cp Giy chng nhn t nguyn tc, tiu
chun GPP c tin hnh thng nht, khch quan, dn ch, kp thi,
v theo ng cc quy nh hin hnh.
2. PHM VI P DNG
Tt c cc i tng tham gia trong qu trnh tip nhn h s, xem xt, thm
nh v cp Giy chng nhn t nguyn tc, tiu chun GPP.
3. TI LIU THAM CHIU
- TCVN ISO 9001:2000
- Lut Dc ban hnh ngy 14/6/2006.
- Ngh nh s 79/2006 ngy 09/08/2006 Quy nh chi tit thi hnh mt s
iu ca Lut Dc.
- Quyt nh s 11/2007/Q-BYT ngy 24/01/2007 ca B trng B Y t
v vic ban hnh nguyn tc, tiu chun Thc hnh tt nh thuc
4. NH NGHA V CH VIT TT
- CBCC: cn b, cng chc
- ISO: L ch vit tt ca tn ca T chc quc t tiu chun ho, c tn
ting Anh l International Organisation of Standardisation.
- QT: l ch vit tt ca quy trnh.
- SYT: l ch vit tt ca S Y t tnh, thnh ph trc thuc Trung ng
- GCN: Giy chng nhn t tiu chun GPP
5. NI DUNG QUY TRNH
5.1. S Quy trnh cp GCN

-2Ngy p dng:

Ln sa i: 00

QT.QLD.GPP

Ngi thc hin

Trnh t thc hin

Ti liu tham
chiu, biu mu

C s bn l

H s ngh ,
h s b sung

5.2.1

Vn th SYT

Nhn,
Trnh lnh o S

5.2.2

Lnh o SYT

Phn chuyn phng

chc nng

5.2.3

Lnh o Phng

Nhn h s,
Phn cng gii quyt

5.2.4
5.2.5

Phiu tip nhn

CV c phn cng

HS
thiu

HS y

CV, Lnh o Phng,

Lnh o SYT
on thm nh

CV, Lnh o Phng,

Lnh o SYT

Vn bn
tr li

Lnh o SYT
Vn th SYT,

5.2.7
BM.QLD.GPP.01

Kt lun

D tho GCN

5.2.8

K Duyt

5.2.9

ng du, chuyn c s,
Lu h s

-3Ngy p dng:

Yu cu
b sung

Thm nh

Khng
t

5.2.6

Yu cu
b sung

Quyt nh thnh lp
on thm nh

5.2.10

Ln sa i: 00

QT.QLD.GPP

5.2. M t Quy trnh cp GCN

5.2.1. C s bn l lp h s :
C s ngh cng nhn t tiu chun GPP lp h s theo quy nh ti
iu 28 Ngh nh 79/2006/N-CP, di y gi chung l h s.
5.2.2. Nhn h s:
B phn vn th ca S Y t c trch nhim tip nhn h s vo s cng
vn n trnh lnh o SYT.
5.2.3. Lnh o SYT chuyn vn bn n cc phng chc nng:
Lnh o SYT xem xt chuyn h s cho phng chc nng.
5.2.4. Lnh o phng chc nng phn cng h s n chuyn vin:
Lnh o phng chc nng phn cng n cc chuyn vin th l h s.
5.2.5. Chuyn vin kim tra u mc h s ghi phiu tip nhn:
Chuyn vin c phn cng chu trch nhim thm nh s b h s theo
ng danh mc quy nh ti phiu tip nhn h s v ghi ni dung vo phiu tip
nhn h s gi cho c s theo biu mu ti Thng t 02/2007/TT-BYT ngy
24/01/2007 (Lu 01 bn vo h s) v bo c s np ph - trng hp h s
ngh cp GCN cng ng thi l h s ngh cp Giy chng nhn iu
kin kinh doanh thuc.
Trng hp h s khng y : chuyn vin d tho thng bo b sung
h s.
Trng hp h s y , Doanh nghip np ph theo quy nh:
chuyn sang bc 5.2.6
H s ng k kim tra GPP ch l nhng thng tin ban u v l c s
lm Quyt nh i kim tra.
SYT thng bo Cc QLD c CBCC tham gia on thm nh (c th gi
qua fax: 04. 8.234.758)
Thi gian ti a t lc c s np h s n lc SYT thng bo vi Cc QLD
l 07 ngy.
Trong thi hn ti a l 05 ngy Cc QLD thng bo tn CBCC tham gia
on thm nh.
Ghi ch: Quy trnh ny c th khc mt s SYT m vic tip nhn h s
thuc phng chc nng (VD Phng mt ca) ch khng qua b phn Vn th
ca SYT

-4Ngy p dng:

Ln sa i: 00

QT.QLD.GPP

5.2.6. Quyt nh thnh lp on thm nh:

- Chuyn vin th l h s d tho Quyt nh thnh lp on thm nh c
s theo mu BM.QLD.04.02. Chuyn vin v lnh o Phng k tt trnh Lnh
o SYT ban hnh.
Thi gian ti a thc hin giai on ny l 03 ngy k t ngy Cc QLD
thng bo CBCC tham gia on thm nh.
- Chuyn vin th l h s chuyn ton b h s v Quyt nh thnh lp
on kim tra cho Th k on kim tra Th k thng bo cho cc thnh vin
on, c s v lch thm nh.
Thi gian ti a thc hin giai on ny l 01 ngy.
5.2.7. T chc thm nh:
- Trong vng 07 ngy k t ngy Quyt nh on thm c k ban hnh,
on thm nh phi tin hnh thm nh ti c s v cc iu kin theo cc tiu
chun GPP (Danh mc kim tra GPP).
Bin bn thm nh c th k on, trng on v ch c s hoc ngi
qun l chuyn mn c mt ti thi im kim tra k xc nhn theo mu s
BM.QLD.01.
Nu kt qu thm nh t yu cu nhng vn cn b sung mt s im th
on thm nh yu cu c s phi b sung theo ng kt lun bin bn thm
nh.
- Trng hp c s thm nh khng t yu cu: chuyn sang bc 5.2.8
- Trng hp c s thm nh t yu cu: Th k on chuyn ton b h
s v bin bn chuyn vin c phn cng th l h s thc hin bc tip
theo (5.2.8)
5.2.8. D tho GCN hoc k duyt Cng vn tr li C s :
Trng hp thm nh t yu cu:
- Chuyn vin th l h s d tho GCN.
- Chuyn vin k tt, chuyn lnh o Phng xem xt, k tt trc khi trnh
lnh o SYT.
Thi gian ti a thc hin 5.2.8 l 02 ngy
(Chuyn sang bc 5.2.9)
Trng hp thm nh khng t yu cu:
- Chuyn vin d tho Cng vn tr li c s: khng t nguyn tc, tiu
chun GPP trnh lnh o Phng .
- Lnh o Phng k tt trnh lnh o SYT. Chuyn sang bc 5.2.10
-5Ngy p dng:

Ln sa i: 00

QT.QLD.GPP

Thi gian ti a thc hin bc 5.2.8 ny l 02 ngy

5.2.9. Lnh o SYT xem xt v k vn bn:
Trng hp Lnh o SYT ng vi kin xut ca phng chc
nng:
Lnh o SYT k GCN hoc k cng vn tr li c s.
(Thi gian ti a thc hin giai on ny l 02 ngy)
Trng hp Lnh o SYT khng ng vi kin xut ca
phng chc nng:
Lnh o SYT yu cu Phng chc nng gii trnh. Phng chc nng
thc hin yu cu v trnh li Lnh o SYT
(Thi gian ti a thc hin giai on ny l 03 ngy)
5.2.10. Vn th ng du, chuyn c s
GCN hoc cng vn tr li chuyn Vn th ng du, gi tr c s v lu
tr theo quy nh.
(Thi gian ti a thc hin giai on ny l 01 ngy)
6. ph lc:
BM.QLD.GPP.01: Bin bn kim tra GPP

-6Ngy p dng:

Ln sa i: 00

QT.QLD.GPP

BM.QLD.GPP.01

S Y t......

bin bn kim tra

"thc hnh tt nh thuc "
Tn c s:...................................................
a ch: ......................................................
Ngi qun l chuyn mn:.....................

Ngy ../.../....

-7Ngy p dng:

Ln sa i: 00

QT.QLD.GPP
Y BAN NHN DN .....

Cng ho x hi ch ngha vit nam

c lp - T do - Hnh phc

S y t.........

, ngy thng nm 20
bin bn kim tra
"thc hnh tt nh thuc "
Cn c Quyt nh s .......... ngy ......... ca .........v vic thnh lp on
kim tra trin khai p dng cc nguyn tc "Thc hnh tt nh thuc" ca S Y
t ti ....., thnh phn on kim tra gm :
1............ - Trng on.
2................ - Th k.
3.................

Tn c s:
- a ch:
- Ngi qun l chuyn mn dc:
- Bn ng k kim tra ngy . ca
- Ngy tin hnh kim tra: .
- Ni dung kim tra: vic trin khai p dng cc tiu chun "Thc hnh tt nh
thuc" ca B Y t
- Tip on c :
1........
2..........
3.......
I/ Mt s kin ca on kim tra:

Sau khi thm nh h s, nghe bo co ca Cng ty v tin hnh kim tra

thc t, on kim tra c mt s kin sau:
A. u im:
1. Ngui qun l chuyn mn:..........
2. Ngi bn l:.........
3. C s vt cht: ....
4. Trang thit b: (thit b bo qun, dng c bao b ra l v pha ch theo
n...)
-8Ngy p dng:

Ln sa i: 00

QT.QLD.GPP

5. Ghi nhn thuc: .....

6. H s s sch v ti liu chuyn mn: .....
7. Thc hin quy ch chuyn mn thc hnh ngh nghip: .....
8. Kim tra/m bo cht lng: ....
B. Tn ti:
9. Ngui qun l chuyn mn:..........
10. Ngi bn l:.........
11. C s vt cht: ....
12. Trang thit b: (thit b bo qun, dng c bao b ra l v pha ch theo
n...)
13. Ghi nhn thuc: .....
14. H s s sch v ti liu chuyn mn: .....
15. Thc hin quy ch chuyn mn thc hnh ngh nghip: .....
16. Kim tra/m bo cht lng: ....
II/ Kt lun:

III/ kin ca C s.
.............................
Bin bn c thng nht gia on kim tra v C s ........
Bin bn ny c lm thnh 03 bn: 01 bn lu ti c s, 01 bn lu ti
S Y t, 01 lu ti Cc QLD (nu Cc QLD tham gia on kim tra).
C s c kim tra
Ngi qun l chuyn mn

on kim tra
Th k
Trng on

-9Ngy p dng:

Ln sa i: 00

Danh mc kim tra thc hnh tt phn phi thuc

Ban hnh km theo Cng vn s 2313/QLD-CL ngy11/ 05/2007 ca
Cc trng Cc Qun l Dc Vit Nam
STT

NI DUNG
Thng tin chung:

2
3
4
5

6
7

TT

* Tn n v:

* a ch n v:
..................................................................................................................................
* S din
thoi:..............................Fax:...................................Email:...............................
* Tn v chc danh ngi gim c hoc ph trch n v:

* Tn v a ch ca c s phn phi thuc:

..................................................................................................................................
* Tn v trnh ca ngi ph trch c s phn phi thuc:
..................................................................................................................................
* C s thuc:
- Doanh nghip sn xut
- Doanh nghip bun bn thuc
- i tng khc
* Tn v trnh chuyn mn ca ngi vn chuyn thuc gy nghin, thuc
hng tm thn, vc xin v sinh phm y t nu c...................................................
* S lng nhn vin theo nghip v
- Sau i hc
- Dc s
- K thut vin
- Dc t
- i hc khc
Ni dung

Tham
chiu

T chc, qun l v nhn s

1

C s c t cch php nhn

khng?

II.1.a

C s t chc nhn s khng? S

c ghi r tn, trnh ca tng

II.1.b

-1-

C
t

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

ngi khng?
3

C vn bn quy nh trch nhim

quyn

II.1.d

hn ca tng c nhn v mi quan

h gia cc c nhn khng?
4

C s c y nhn vin c trnh

ph hp vi cng vic c giao
khng?

II.1.c

C bn m t cng vic ca tng c

nhn khng?

II.1.

C hp ng hay y quyn y
i vi cc cng vic do nhn vin
hay t chc khc thc hin khng?

II.1.e

C s c cc quy nh v an ton lao II.1.g

ng ca nhn vin v ti sn
khng?

C quy trnh v thit b s cu x II.2.h

l cc trng hp nh hng n s
an ton ca nhn vin khng?

Kho v mi trng xung quanh c

thun tin cho vic lm v sinh mi
trng khng?

II.1.g

10

Nhn vin c c hun luyn y

v GDP khng?

II.2.a

11

C k hoch hun luyn hng nm

vi ni dung c th v GDP khng?

II.2.d

12

K hoch hun luyn v o to c

c thc hin y khng?

II.2.d

13

C nh gi c th ca vic hun
luyn o to khng?

II.2.d

14

H s hun luyn c c lu li
khng?

II.2.d

15

C nh gi hng nm v k hoch
hun luyn khng?

II.2.d

16

Nhn vin c h s sc khe ban

u v nh k kim tra khng? Bao

II.2.

II.2.b,c

-2-

C
t

Khng
t

Khng

Nhn
xt

Ni dung

TT

Tham
chiu

lu mt ln?
17

Nhn vin lm vic ti ni tip xc

vi cc thuc nguy him (sn phm
c hot tnh cao, c, d gy nhim
trng hay gy d ng) c c cung
cp trang phc bo h cn thit
khng?

II.2.g

18

C cc quy trnh v v sinh c nhn

cho nhn vin ph hp vi cc hot
ng tin hnh khng?

II..2.e

19

C trang phc bo h lao ng cho

II.2.g
nhn vin ph hp vi cc hot ng
tin hnh khng?

Qun l cht lng

20

C s c chnh sch cht lng

khng?

II.3.a

21

Chnh sch cht lng c c ban

lnh o chnh thc ph duyt v
cng b khng?

II.3.a

22

C cc quy trnh cung ng v xut

kho ph hp v hp l khng?

II.3.

23

Thuc c c mua t cc nh cung

cp hp php c nh gi chp
thun khng?

II.3.

24

Thuc c c phn phi ti cc c

s, php nhn c giy php iu
kin kinh doanh khng?

II.3.

25

Vic cung ng v xut kho c c II.3.

thc hin theo ng cc quy trnh
ban hnh khng?

26

C cc quy trnh lm vic cho cc

hot ng hnh chnh v k thut
khng?

II.3.g

27

Cc quy trnh ny c c ph
duyt, ban hnh chnh thc bi cn
b c thm quyn khng?

II.3.g

28

Vic lu gi h s s sch c m

II.3.e
-3-

C
t

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

bo vic truy cu d dng khng?

29

Thuc c c cung cp, bn v

phn phi bi cc c s hp php
khng?

II.3.h
II.7.a

C s, kho tng v bo qun

30

Kho c cc khu vc ring c xy

dng, b tr v trang b ph hp cho
cc mc ch sau khng:

II.4.a

- Khu vc bo qun
- Khu vc nhn v xut hng
- Khu vc ly mu
- Khu vc hng ch x l: Thuc b
loi, ht hn
- Khu vc hng loi: Thuc thu hi,
nghi ng thuc gi,...
Khu vc bo qun
31

C bng ni quy ra vo v cc bin

II.4.b
php cn thit hn ch vic ra vo
khu vc bo qun khng?

32

Din tch v dung tch khu vc bo

qun thuc c v hp l cho
php bo qun cc loi sn phm
khc nhau khng?

II.4.c

33

Khu vc bo qun c m bo sch,

kh v c duy tr trong gii hn
nhit v m thch hp khng?

II.4.d

34

Hng ha trong khu vc bo qun c II.4.

c trn gi k khng?

35

Gi k bo qun thuc c trong tnh

trng tt, sch s khng?

36

Khong cch gia cc gi, k c II.4.

rng d dng lm v sinh v kim
tra thuc khng?

37

C cc quy trnh lm v sinh v

phng php v sinh bng vn bn
cho khu vc bo qun khng?

II.4.

II.4.e

-4-

C
t

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

38

C cc quy trnh bng vn bn v

bin php kim sot cn trng
khng?

39

Cc dng c, ha cht kim sot cn II.4.e

trng c gy nguy c tp nhim i
vi hng ha c bo qun khng?

40

C khu vc ly mu ring bit

khng?

II.4.g

41

Khu vc ly mu nguyn liu, t

dc lm thuc c c cung cp
kh sch m bo yu cu khng?

II.4.g

42

C quy trnh v sinh thch hp cho

khu vc ly mu trnh nhim
v nhim cho khng?

II.4.g

43

Khu vc tip nhn, cp pht c c II.4.h

thit k, xy dng v trang b ph
hp c th lm sch bao b trc
khi nhp kho khng?

44

Khu vc tip nhn, cp pht c kh II.4.h

nng bo v thuc khng b nh
hng xu ca thi tit v cc ngun
nhim khc khng?

45

Khu vc bit tr sn phm c c

tch bit khng?

II.4.i

46

C bin hiu v c quy nh i vi

nhn vin ra vo khu vc bit tr
khng?

II.4.i

47

Cc bin php vt l kim sot an

ton thay th c c thm nh
m bo an ninh khng?

II.4.i

48

C cc bin php cch ly vt l v

bin hiu r rng i vi cc thuc
b thu hi, thuc loi b, thuc ht
hn, .. khng?

II.4.k

Cc thuc b loi b c c dn
nhn r rng v c kim sot
khng?

II.4.o

49

II.4.e

II.8.l

-5-

C
t

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

50

C cc khu vc bo qun ring m

bo an ninh, an ton cho cc thuc
phng x, thuc gy nghin, thuc
hng tm thn, thuc nhy cm v
cc thuc c nguy c b lm dng,
gy chy, n,...khng?

II.4.l

51

Cc thuc gy nghin, thuc hng

tm thn c c bo qun ring
theo ng cc quy nh hin hnh
khng?

II.4.p

52

Khu vc bo qun c cc kho dnh

ring cho:

II.4.l

- Bo qun nguyn liu, t dc lm

thuc
- Bo qun vc xin v sinh phm y t
53

Cc sn phm vc xin v sinh phm

y t c c thit lp h thng dy
chuyn lnh (kho lnh, t lnh di
ng, xe lnh,...) cho khu vc bo
qun, vn chuyn v phn phi
khng?

II.4.l

54

Kho lnh c th tch ph hp

khng?

II.4.l

55

C h thng pht in d phng

cho hot ng ca kho lnh khng?

II.4.l

56

C trang b cc thit b dng theo II.4.l

di lin tc cc iu kin bo qun
(nhit , m) khng?

57

Kho lnh c c trang b cc thit

b ghi t ng v c h thng bo
ng khi nhit vt ra ngoi gii
hn cho php khng?

II.4.l

58

Cc thuc c c x l, bo qun
ph hp nhm trnh tp nhim,
nhim cho ln ln khng?

II.4.m

59

C bin php nhm m bo cc

nguyn tc nhp trc-xut trc
(FIFO) v ht hn trc-xut trc

II.4.n

-6-

C
t

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

(FEFO) c tun th trong cp

pht khng?
60

C khu vc ring bo qun cc

thuc b v, b hng khng?

II.4.q

61

Khu vc bo qun c c xy dng II.4.r

v b tr m bo phng chy cha
chy khng?

62

Khu vc bo qun c c cung cp

y nh sng m bo cc
hot ng c tin hnh chnh xc
v an ton khng?

II.4.r

iu kin bo qun
63

Cc thuc c c bo qun ng
iu kin ghi trn nhn khng?

II.4.s

Theo di iu kin bo qun

64

Vic theo di iu kin bo qun

thuc c c ghi chp li y
khng?

II.4.u

65

Cc thit b dng theo di iu

kin bo qun c c nh k hiu
chun khng?

II.4.u
II.4.v

66

Kt qu kim tra, hiu chun thit b II.4.u

c c ghi li khng?

67

C tin hnh nh gi ng u
ca khu vc kho bo qun khng?

II.4.v

68

Thit b theo di nhit c c

t ti nhng v tr c s thay i
nhit nhiu nht khng?

II.4.v

69

C xy dng gi tr cnh bo v gi
tr hnh ng i vi vic theo di
nhit bo qun ca cc thuc c
yu cu bo qun c bit nh vc
xin v sinh phm y t khng?

II.4.v

70

Cc hot ng sa cha i vi thit II.4.v

b bo qun, thit b theo di iu
kin bo qun c c ghi li v
nh gi nh hng ti cht lng
-7-

C
t

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

thuc khng?
71

C nh gi s nh hng ca cc
thay i nm ngoi gii hn cho
php ti cht lng thuc khng?

II.4.v

Kim sot quay vng kho

72

Vic i chiu tn kho trn s sch

v thc t c c tin hnh nh k
khng? Bao lu mt ln?

II.4.y

73

Cc sai lch, tht thot c c iu

tra nguyn nhn v bin php khc
phc khng?

II.4.z

Phng tin vn chuyn v trang thit b

74

Cc phng tin v trang thit b vn II.5.a

chuyn c bo v c thuc v bao
b khi cc tc nhn bn ngoi v s
nhim bn khng?

75

Cc phng tin vn chuyn v

trang thit b c c thit k ph
hp, d v sinh v bo dng
khng? C lu n thit b x
l cc loi thuc khng c bo v
bi thng cactng hoc bao b ln
khng?

II.5.b

C quy trnh lm v sinh bng vn

bn cc phng tin vn chuyn v
trang thit b khng? Bao lu mt
ln?

II.5.c

77

Cc quy trnh v sinh c c tin

hnh v ghi chp li khng?

II.5.c

78

Cc iu kin bo qun c bit

trong qu trnh vn chuyn (chng
hn nh: vc xin v sinh phm y t,
) c c m bo ng khng?

II.5.c

C nh gi ng u nhit
trong cc phng tin bo qun ny
khng?

II.5.c

iu kin bo qun c c duy tr

II.5.c

76

79

80

II.5.i

II.5.g

II.5.k

II.5.k

-8-

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

trong gii hn cho php v c

theo di lin tc trong qu trnh vn
chuyn khng? Vic theo di c
c ghi chp li v lu h s
khng?

II.5.k

81

Nu dng cc thng xp cch nhit

vi ti lm lnh ( kh, gel
kh,...) bo qun vc xin, sinh
phm: c nh gi thm nh lng
ti lm lnh v thi gian s dng
m bo duy tr nhit trong
khong gii hn cho php khng?

II.5.c

82

Cc thit b theo di c c nh
gi thm nh, nh k hiu chun
khng?

II.5.c

II.8.

II.5.k
II.5.l

83

Cc phng tin vn chuyn theo

II.5.c
hp ng c c nh gi khng?
II.5.k
Cc iu kin bo qun trong qu
trnh vn chuyn c c theo di v
ghi li khng?

84

Trong qu trnh vn chyn c thc

II.5.k
hin vic theo di iu kin bo
qun c bit nu c khng? C
thc hin vic o nhit ti cc
im khc nhau ca phng tin
chng minh ng u v nhit
mi ch trn phng tin khng?

85

C kim tra, theo di v lu h s

cc iu kin bo qun ny khng?

II.5.k

86

Cc h s theo di iu kin bo
qun c c lu gi t nht mt
nm sau khi cc sn phm ht hn
khng?

II.5.k

87

C bin php tch bit cc phng

tin vn chuyn v trang thit b
hng khng?

II.5.e

88

C cc quy trnh vn hnh v bo

dng cc phng tin vn chuyn

II.5.f

-9-

C
t

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

v trang thit b khng?

89

C quy trnh bng vn bn v bin

II.5.h
php phng chng s thm nhp ca
cc loi gm nhm, mi mt, chim
v cc loi cn trng vo cc
phng tin vn chuyn khng?

90

Cc ha cht v dng c v sinh c

m bo khng lm nh hng n
cht lng thuc v gy tp nhim
cho thuc khng?

II.5.h

91

Phng tin vn chuyn c ln

sp xp, bo qun trt t cc loi
thuc khc nhau khng?

II.5.m

92

C bin php cch ly cc thuc loi

b, thu hi trong qu trnh vn
chuyn khng?

II.5.n

93

C bin php ngn nga vic i vo,

lc li phng tin vn chuyn v
trang thit b khng?

II.5.o
II.8.p

Bao b v nhn trn bao b.

94

Thuc c c bo qun v phn

phi trong cc bao b ph hp vi
c tnh ca tng loi khng?

II.6.a

95

Cc bao b ny c kh nng bo v
thuc khi nh hng ca mi
trng, k c vic nhim khun
khng?

II.6.a

96

Bao b c nhn r rng, d c, y

cc thng tin theo quy nh v
c dn chc chn khng?

II.6.b

97

Trn nhn c ghi y cc thng

tin v iu kin bo qun, iu kin
vn chuyn c bit khng?

II.6.d

98

Nhn trn bao b c s dng cc t

vit tt, tn hoc m s khng c
chp nhn trong giao dch quc t
hoc quc gia khng?

II.6.

II.8.o

- 10 -

C
t

Khng
t

Khng

Nhn
xt

Ni dung

TT

99

Tham
chiu

Nu s dng nc kh t trong II.6.e

bao b thuc, c m bo rng thuc
khng tip xc vi nc kh
khng?

100 C thng xuyn kim tra bao b

pht hin tnh trng h hng, rch,
mt nhn khin khng cn nhn
dng c hng ha khng?

II.6.g

101 C sn cc quy trnh cho vic x l

cc bao b b h hi, d v khng?

II.6.g

giao hng v gi hng

102 Vic giao hng-gi hng v vn
chuyn thuc c c tin hnh ch
khi c lnh giao hng khng? lch
giao hng c c lu li khng?

II.7.c

103 C quy trnh giao hng-gi hng

khng?

II.7.d

104 Cc quy trnh ny c tnh n bn

cht ca thuc cng nh cc ch
c bit no cn quan tm khng?

II.7.d

105 H s giao hng c ghi r:

II.7.

- Ngy gi
- Tn v a ch ca php nhn chu
trch nhim vn chuyn hoc tn
ca ngi giao hng
- Tn v a ch ca c s, ngi
nhn hng
- M t sn phm
- S lng v cht lng sn phm
- S l v hn dng ca sn phm
- Cc iu kin bo qun v vn
chuyn
- M s cho php xc nh c
lnh giao hng
106 H s giao hng-gi hng c c

II.7.e
- 11 -

C
t

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

Khng

Khng
t

lu li khng? C cho php d dng

truy cu tt c cc bn lin quan
trong qu trnh phn phi khng?
107 H s ny c m bo vic thu hi
nhanh chng mt l sn phm
khng?

II.7.e

108 Phng php vn chuyn c la

chn c tnh n cc iu kin ti
a phng v kh hu khng?

II.7.g

109 Cc thuc c c bo qun v vn

chuyn ph hp vi iu kin yu
cu trong qu trnh vn chuyn
khng?

II.7.g

110 C xy dng lch giao hng v lch

trnh ng i khng? C kh thi
khng?

II.7.h

111 Lng thuc c giao c lu n

kh nng bo qun ca c s nhn
hng khng?

II.7.h

112 Nguyn tc d trc/xp sau c

c tun th khng?

II.7.i

113 C bin php trnh v khi xp,

d hng khng?

II.7.i

114 C m bo cc thuc km cht

lng, thuc ht hn s dng, thuc
gn ht hn s dng khng a vo
qu trnh phn phi khng?

II.7.k

II.8.d

vn chuyn v thuc trong qu trnh vn chuyn.

115 C m bo thuc gi nguyn tnh
ton vn v cht lng ca thuc
trong qu trnh vn chuyn v bo
qun khng?

II.8.a
II.8.e

116 Cc qu trnh vn chuyn c m

II.8.c
bo: khng lm mt thng tin gip
nhn dng sn phm, tnh ton vn
ca sn phm, v cc iu kin nhit
, m trong sut qu trnh vn
chuyn, bo qun khng?
- 12 -

Nhn
xt

TT

Ni dung

Tham
chiu

117 Cc thay i so vi iu kin bo

qun theo yu cu c c s ng
ca ngi s hu giy php lu
hnh hay nh sn xut khng?

II.8. d

118 Trong qu trnh vn chuyn, cc yu II.8.

cu bo qun c bit khc vi iu
kin mi trng bit c c m
bo, c theo di v ghi chp li
khng?
119 C quy trnh x l cc vi phm v
iu kin bo qun khng?

II.8.g

120 Vic vn chuyn v bo qun cc

thuc c hot tnh cao, thuc phng
x, thuc nguy him, c tun th
cc quy nh hin hnh khng?

II.8.h

121 Vic vn chuyn v bo qun cc

thuc c cht gy nghin, cht
hng tm thn, c tun th cc
quy nh hin hnh khng?

II.8.i

122 C cc bin php cch ly c hc

hoc cc bin php tng ng
bo qun bit tr cc thuc b loi,
thuc ht hn s dng, thuc nghi
ng l thuc gi, thuc b thu hi v
thuc b tr v trong qu trnh vn
chuyn khng?

II.8.l

123 Vic vn chuyn v bo qun cc

thuc gy nghin, hng thn,
nguyn liu d chy ,.. c tun th
cc quy nh hin hnh khng?

II.8.m

124 C cc phng tin vn chuyn

II.8.h
chuyn dng v bo m an ninh i II.8.i
vi cc thuc trn khng?
II.8.m
125 C quy trnh x l cc thuc b trn, II.8.k
b ngn nga tp nhim,
nhim cho v nguy c khc khng?
126 Bn trong ca cc phng tin v

II.8.n
- 13 -

C
t

Khng
t

Khng

Nhn
xt

Ni dung

TT

Tham
chiu

bao b vn chuyn c sch v kh

trong qu trnh vn chuyn khng?
127 Cc s c trong qu trnh vn
chuyn c c ghi li v bo co
cho cc b phn lin quan khng?

II.8.r

128 Cc ti liu thch hp c c km

II.8.s
theo trong sut qu trnh vn chuyn
thuc khng?
h s ti liu
129 C s c sn cc quy ch, quy nh,
h s, ti liu lin quan n hot
ng kinh doanh thuc khng?

II.9.a

130 C cc quy trnh son tho bng vn

bn cho vic:

II.9.c

- t hng, n t hng
- Tip nhn, kim tra vic nhn hng
- Giao hng
- Bo qun
- V sinh, bo dng nh xng
- Ghi chp cc iu kin bo qun
- An ninh
- Tip nhn v x l sn phm tr
v, thu hi.
131 Cc hng dn, quy trnh cho cc
thao tc lin quan n cht lng
thuc c thit k, r sot, ph
duyt, phn phi mt cch thn
trng khng?

II.9.

132 C cc quy trnh bin son, kim

II.9.d
sot v r sot, kim sot thay i
i vi cc ti liu lin quan khng?
133 Cc quy trnh ny c c thc hin
khng?

II.9.d

134 H s, ti liu, cc ghi chp c r

rng, d hiu, theo trt t, d tra cu

II.9.e
II.9.h

- 14 -

C
t

Khng
t

Khng

Nhn
xt

Ni dung

TT

Tham
chiu

khng?
135 Cc ti liu c c xt duyt, k
tn v ghi ngy thng bi nhng
ngi c thm quyn khng?

II.9.g

Cc h s ghi chp
136 Cc ghi chp lin quan n tt c
cc hot ng c c ghi chp ti
thi im din ra mi thao tc
khng?

II.9.h

137 Cc ghi chp ca mi ln bun bn

c m bo tra cu c s lng,
xut x v ni n ca tng l sn
phm khng?

II.9.i

138 H s ti liu c c lu gi theo

II.9.k
ng quy nh ca php lut khng?
139 C thng xuyn r sot, cp nht
h thng h s, ti liu khng?

II.9.n

140 C cc quy trnh nhn dng, thu

thp, ln mc lc, truy cp, bo
qun, bo dng, x l v tip cn
vi tt c cc h s, ti liu khng?

II.9.l

141 Cc s sch c c bo qun v lu II.9.m

tr an ton khng? C sn sng cho
vic truy cp khi cn thit khng?
142 S sch v bo qun thuc c c
lu gi theo ng quy nh ca
Thc hnh tt bo qun thuc
khng?

II.9.p

143 C bn sao trnh b mt d liu

khi s dng h thng qun l thng
tin bng in t khng?

II.9.q

ng gi li v dn nhn li
144 Vic ng gi li (k c dn nhn
li) c c cp php khng?

II.10.a

145 C thc hin theo ng cc nguyn

tc ca Thc hnh tt sn xut

II.10.a

- 15 -

C
t

Khng
t

Khng

Nhn
xt

Ni dung

TT

Tham
chiu

thuc khng?
146 C ghi r tn c s sn xut v tn
c s ng gi li trn bao b
khng?

II.10.a

147 i vi thuc nhp khu, c cc khu II.10.b

vc ring dnh cho vic dn nhn
ph, b sung t hng dn khng?
148 Khu vc ny c m bo:

II.10.b

- phng tp nhim v trnh

nhim cho
- V sinh
- Duy tr tnh ton vn ca l
- Lu gi nhn gc v nhn dn li
- Lu mu nhn theo tng l
- Duy tr tnh ton vn v kh nng
nhn dng ca sn phm
149 L sn phm c c cung cp
II.10.c
phiu kim nghim ca nh sn xut
gc v phiu kim nghim mi (nu
c) khng?
150 Cc thng tin v sn phm trn
II.10.c
phiu kim nghim mi c cho php
vic truy li phiu kim nghim gc
khng?
151 C quy trnh v bin php phn bit
thuc trc v sau khi ng gi li
khng?

II.10.d

152 C quy trnh v bin php m

II.10.d
bo duy tr cht lng thuc trc v
sau khi ng gi li khng?
Khiu ni
153 C cc quy trnh bng vn bn x II.11.a
l khiu ni khng?
154 C quy trnh x l bng vn bn
II.11.b
xem xt cc khiu ni, thng tin lin
quan n thuc km cht lng
- 16 -

C
t

Khng
t

Khng

Nhn
xt

Ni dung

TT

Tham
chiu

khng?
155 Cc khiu ni lin quan n li ca
thuc c c ghi li v iu tra
thu o khng?

II.11.c

156 C kim tra cc l khc ca cng

mt sn phm khi pht hin ra li
mt l khng?

II.11.d

157 C cc bin php x l tip theo sau

vic iu tra v nh gi khiu ni
khi cn thit khng?

II.11.

Thu hi
158 C quy trnh bng vn bn thu
hi cc thuc c xc nh hoc
nghi ng c khim khuyt khng?

II.12.a

159 Quy trnh ny c gip cho vic thu

II.12.a
hi nhanh chng v hiu qu khng?
C ch r ngi chu trch nhim
chnh khng?
160 Quy trnh ny c c kim tra v
cp nht thng xuyn khng?

II.12.b

161 Vic thu hi thuc c c thng

II.12.c
bo v phi hp cht ch vi nh sn
xut gc khng?
162 C thng bo ngay lp tc v vic
thu hi n cc tt c khch hng v
c quan chc nng c lin quan
khng?

II.12.h

163 Ngi chu trch nhim thu hi c

c cung cp cc thng tin v sn
phm cng nh danh sch khch
hng mua thuc khng?

II.12.i

164 C nh k nh gi hiu qu ca
vic thu hi thuc khng?

II.12.d

165 Cc sn phm thu hi v c c

bo qun ring bit v an ton
khng?

II.12.

166 Cc sn phm thu hi c c bo

II.12.e
- 17 -

C
t

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

qun ring bit hay dn nhn

phn bit trong qu trnh vn chuyn
khng?
167 iu kin bo qun cc thuc b loi II.12.g
b v sn phm thu hi trong qu
II.13.a
trnh bo qun v vn chuyn c
c duy tr cho n khi c quyt
nh cui cng khng?
168 Din bin v s liu ca qu trnh
thu hi c c ghi chp li khng?
C bo co cui cng khng?

II.12.k

Sn phm b loi v b tr v
169 Sn phm b loi b v tr li cho
nh phn phi c c nhn dng
ph hp v c x l theo mt quy
trnh khng?

II.13.a

170 Sn phm b loi b v tr li c

c bo qun khu vc ring
nhm ngn nga vic ti phn phi
v nhm ln cho n khi c quyt
nh cui cng khng?

II.13.a

171 Vic nh gi v quyt nh v x l II.13.b

thuc loi b, thuc tr v c c
thc hin bi ngi c phn cng
khng?
172 Ngi ny c vn bn phn cng
ca ngi c thm quyn khng?

II.13.b

173 Cc sn phm tr li c a v
khu hng bn phi m bo:

II.13.c

- Tnh nguyn vn: nim phong, bao

b,...
- c bo qun v x l trong cc
iu kin ph hp
- Tui th cn li m bo ng quy
nh
- Sn phm c kim tra v nh
gi bi ngi c thm quyn.
- 18 -

C
t

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

174 C m bo khng ti xut hay ti

s dng cc thuc ang c nghi ng
v cht lng khng?

II.13.d

175 C cc phng tin v trang thit

b vn chuyn cc thuc b tr li
mt cch an ton v ph hp theo
ng iu kin bo qun v yu cu
khc khng?

II.13.

176 Cc phng tin v trang thit b II.13.e

vn chuyn cc thuc b loi c m
bo an ton v ph hp trc khi x
l khng?
177 Thuc c c hy theo ng quy
II.13.g
nh khng? C h s thu hi thuc,
bo co thu hi v bin bn hy
thuc theo quy nh khng?
179 Vic lu gi h s sn phm b tr
li, b loi b v hy c theo ng
quy nh khng?

II.13.h

Thuc gi
179 C tch ring ngay lp tc cc thuc II.14.a
gi c pht hin khng?
180 C ghi chp li h s khng?

II.14.a

181 C thng bo ngay cho ngi c

cp php lu hnh v c quan chc
nng v cc thuc khi pht hin
hoc c nghi ng l thuc gi
khng?

II.14.b

182 Cc thuc gi hay thuc b nghi ng

l thuc gi c c tch ring v
dn nhn r rng khng?

II.14.c

183 Vic hy b thuc gi c c thc

hin bi quyt nh chnh thc
khng?

II.14.d

184 Vic hy b c c ghi chp li

khng?

II.14.d

185 H s ca vic hy b c c lu

II.14.d

- 19 -

C
t

Khng
t

Khng

Nhn
xt

Ni dung

TT

Tham
chiu

li khng?
Nhp khu
186 Vic nhp khu-xut khu c tun
th ng cc quy nh ca Php lut
khng?

II.15.a

187 Thuc nhp khu (tr nhng sn

phm c nhp dng bn thnh
phm v ng gi hoc sn xut ra
dng thnh phm) c c ng
trong bao b gc khng?

II.15.b

188 Cc l hng lu gi ca khu c

c lu gi theo ng iu kin
bo qun khng?

II.15.c

189 C cc bin php ph hp m

bo thuc c x l v bo qun
ph hp ti sn bay, hi cng
khng?

II.15.d

190 C ngi c o to tham gia vo

quy trnh gii quyt th tc Hi
quan khi cn thit khng?

II.15.

Hot ng theo hp ng
191 C cc hp ng bng vn bn cho
vic phn phi c y quyn cho
c nhn hay t chc khc khng?

II.16.a

192 Trong hp ng c ghi r trch

nhim ca mi bn khng?

II.16.b

193 Trong hp ng c yu cu r: phi II.16.b

tun th cc nguyn tc: Thc hnh
tt phn phi thuc khng?
194 Cc bn nhn hp ng c tun th
cc nguyn tc ny khng?

II.16.c

195 Cc hp ng ph c c chp
thun bng vn bn ca bn hp
ng khng?

II.16.d

196 C thanh tra, kim tra nh k cc

bn nhn hp ng khng? Bao lu
mt ln?

II.16.

- 20 -

C
t

Khng
t

Khng

Nhn
xt

TT

Ni dung

Tham
chiu

C
t

Khng
t

Khng

Nhn
xt

T kim tra
197 C tin hnh t kim tra nh k
khng? Bao lu mt ln?

II.17.a

198 C tin hnh t kim tra t xut

khng?

II.17.a

199 C quyt nh thnh lp ban thanh

tra khng?

II.17.b

200 C ban hnh quy trnh t kim tra

khng?

II.17.b

201 Vic thanh tra c c tin hnh c II.17.b

lp v chi tit khng?
202 Sau cc t t kim tra c bo co
kim tra khng?

II.17.c

203 Trong bo co c ghi r cc tn ti

v bin php cn khc phc v thi
gian khc phc khng?

II.17.c

204 C chng trnh sa cha nhng sai

st pht hin trong qu trnh kim
tra khng?

II.17.c

205 Cc hnh ng khc phc c c

ghi li khng?

II.17.c

206 C tin hnh nh gi cc hnh

ng khc phc khng?

II.17.c

Ch thch: Mc Tham chiu theo cc ni dung ti Phn II bn nguyn tc

Thc hnh tt phn phi thuc ban hnh km theo quyt nh s 12/2007/QBYT ngy 24 thng 1 nm 2007 ca B trng B Y t.

- 21 -

U BAN NHN DN .
S Y T

QUY TRNH
CP GIY CHNG NHN T TIU CHUN
THC HNH TT PHN PHI THUC (GDP)
QT.QLD.GDP

Ngi vit
H v tn
K

Ngi kim tra

Ngi ph duyt

QT.QLD.GDP

S Y T

QUY TRNH
CP GIY CHNG NHN
THC HNH TT
PHN PHI THUC (GDP)

M s: QT.QLD.GDP
Ngy ban hnh:
Ln sa i:
Tng s trang:

1. Ngi c lin quan phi nghin cu v thc hin ng cc ni dung ca

quy nh ny.
2. Mi phng chc nng c phn phi 01 bn (c ng du kim sot).

File mm c cung cp trn

NI NHN (ghi r ni nhn ri nh du X bn cnh)

THEO DI TNH TRNG SA I (tnh trng sa i so vi bn trc )

Trang

Ngy p dng:

Hng mc
sa i

Tm tt ni dung hng mc sa i

-1-

Ln sa i: 00

QT.QLD.GDP

1. MC CH
Tiu chun ha vic xem xt cp Giy chng nhn t nguyn tc, tiu chun
GDP nhm m bo:
- S cng khai, minh bch trong qu trnh xem xt, thm nh v cp .
- Vic xem xt, thm nh v cp Giy chng nhn t nguyn tc, tiu
chun GDP c tin hnh thng nht, khch quan, dn ch, kp thi,
v theo ng cc quy nh hin hnh.
2. PHM VI P DNG
p dng cho hot ng cp giy chng nhn GDP.
3. TI LIU THAM CHIU
- Lut Dc ban hnh ngy 14/6/2006.
- Ngh nh s 79/2006 ngy 09/08/2006 Quy nh chi tit thi hnh mt
s iu ca Lut Dc.
- Quyt nh 12/2007/Q-BYT ngy 24/1/2007 ca B trng B Y t
v vic trin khai p dng cc nguyn tc thc hnh tt phn phi
thuc.
4. NH NGHA V CH VIT TT
4.1. Thut ng:
GDP: vit tt ca Good Distribution Practices - Thc hnh tt phn phi
thuc.
Phn phi thuc: l vic phn chia v di chuyn, bo qun thuc t kho
ca c s sn xut thuc hoc t trung tm phn phi cho n ngi s dng
hoc n cc im phn phi bo qun trung gian hoc gia cc im phn phi,
bo qun trung gian bng cc phng tin vn chuyn khc nhau.
Bit tr: l tnh trng cc thuc c ring bit, trong mt khu vc cch
ly hoc bng bin php hnh chnh ch quyt nh c php nhp kho, xut
kho cho bo ch, ng gi, phn phi hoc hu b
4.2. Ch vit tt:
- GDP: Thc hnh tt phn phi thuc
- GP: Thc hnh tt
- SYT: S Y t
- QLD: Qun l Dc
5. NI DUNG QUY TRNH
5.1 S qu trnh cp giy chng nhn GDP:

Ngy p dng:

-2-

Ln sa i: 00

QT.QLD.GDP
Trch nhim

S qu trnh thc hin

M t/Biu mu

ngh
Vn th SYT v
vn th phng
chc nng
Trng phng

Chuyn
thm nh

vin

Lnh o phng
Chuyn vin
Lnh o phng
Lnh o S Y t
Th k
kim tra

Tip nhn h s

Phn cng

Thm nh h s

Xem xt

Chun b KH kim tra

Xem xt

on

5.2.1

5.2.2

5.2.3

5.2.4
5.2.5
5.2.6
5.2.7

Hon thin KH

Lnh o S Y t

5.2.8
Ph duyt

Chuyn vin
Th k
an kim tra

5.2.9
Chun b kim tra
Kim tra c s

Th k
Trng on
Lnh o phng

5.2.10
BM.QLD.GDP.01
5.3

X l sau kim tra

Lnh o cc
Lu h s

Ngy p dng:

-3-

Ln sa i: 00

QT.QLD.GDP

5.2 M t s qu trnh qu trnh cp giy chng nhn GDP:

5.2.1. Nhn h s:
B phn vn th ca S Y t c trch nhim tip nhn h s vo s cng
vn n trnh lnh o SYT.
5.2.2. Phn cng:
Lnh o SYT xem xt chuyn h s cho phng chc nng.
Lnh o phng chc nng phn cng n cc chuyn vin th l h s.
5.2.3. Thm nh h s:
Thi gian: Phi tin hnh thm nh h s sau 7 ngy k t ngy nhn cng vn
Tiu chun thm nh h s: Theo yu cu cu ca Quyt nh
12/2007/Q-BYT ngy 24/1/2007 ca B trng B Y t v vic trin
khai p dng cc nguyn tc Thc hnh tt phn phi thuc.
Thnh phn thm nh: Chuyn vin c phn cng qun l h s.
Sau khi tin hnh thm nh:
- Nu h s cha p ng cn phi b sung, hon thin th chuyn
vin c phn cng qun l h s phi thng bo cho c s
b sung h s theo Quyt nh trn.
- Nu h s p ng hoc sau khi c s b sung y (i vi
h s cn b sung) chuyn vin th l h s ghi phiu tip nhn h
s gi cho Doanh nghip theo biu mu ti Thng t 02/2007/TTBYT ngy 24/01/2007 (Lu 01 bn vo h s) v chuyn h s ln
lnh o phng.
5.2.4 Xem xt
Lnh o phng tin hnh xem xt H s:
- Nu thy cn iu chnh, tr li bc 5.2.3
- Nu ng , chuyn tr chuyn vin th l h s thc hin cc
bc tip theo (chuyn vin c phn cng thng bo cho c s
v ph phi np). Sau khi c s hon tt th tc ti chnh tip tc
chuyn sang mc 5.2.5
H s ng k kim tra GDP ch l nhng thng tin ban u v l c s
lm quyt nh i kim tra GDP.
5.2.5. Chun b k hoch kim tra:
Chun b lch:
Chuyn vin c phn cng cn c vo bn ng k kim tra ca c s,
vic b sung h s ca c s (nu c), thng nht vi c s v ln lch kim
tra thc t c s trong vng khng qu 1 thng k t ngy np h s y
v hon tt th tc ti chnh.
Lp k hoch kim tra:
Lch trnh kim tra d kin ( c thng nht vi c s)
Thnh phn on kim tra:
Ngy p dng:

-4-

Ln sa i: 00

QT.QLD.GDP

- Cc Qun l Dc Vit Nam (tham gia n ht ngy 31/12/2007):

SYT thng bo cho Cc Qun l dc Vit Nam c cn b tham
gia on kim tra (c th gi qua Fax: 04. 8234758). Trong thi
gian 7 ngy sau khi nhn c n ngh ng k kim tra GDP
ca c s, S Y t Tnh, Thnh ph thng bo Cc QLD c cn
b tham gia.
- Trng on kim tra
- Th k on kim tra: phng chc nng
- Cc thnh vin
Kinh ph: D tr kinh ph, v cc phng tin cn thit cho vic kim tra c s
Bo co: Lnh o phng lm vic vi cc thnh phn phi hp thng nht
v k hoch kim tra d kin v bo co k hoch kim tra ln lnh o S
5.2.6 Xem xt k hoch kim tra
Lnh o S xem xt k hoch kim tra:
+ Nu khng ng : tr li bc 5.2.5 yu cu iu chnh
+ Nu ng chuyn bc 5.2.7
5.2.7 Hon thin k hoch kim tra: Son tho quyt nh thnh lp on
kim tra:
Sau khi Cc Qun l Dc Vit Nam c ngi tham gia (tham gia n ht
ngy 31/12/2007), trng phng chc nng ch o chuyn vin th k d
tho quyt nh thnh lp on kim tra. Chuyn vin v lnh o phng
k nhy vo quyt nh kim tra, trnh lnh o SYT k.
5.2.8 Ph duyt quyt nh kim tra
Lnh o S xem xt ph duyt quyt nh kim tra.
5.2.9 Chun b kim tra : Sau khi c quyt nh, th k on:
Nhn ton b h s lin quan t chuyn vin th l h s.
Chuyn cc quyt nh sau khi k ti trng on v cc thnh vin
trong on.
Lin h vi trng on v cc thnh vin trong on h sp xp cng
vic theo lch d kin kim tra ng thi chuyn cc h s ti liu ti cc
thnh vin trong on
Thng bo cho c s thi gian kim tra chnh thc.
5.2.10 Kim tra: Bao gm cc bc sau y
5.2.10.1 Cuc hp ban u vi cng ty:
on kim tra:
- Trng on nu r phm vi v mc ch ca t kim tra.
- Gii thiu th k c quyt nh ca lnh o S v thnh lp on
kim tra.
- Gii thiu cc thnh vin trong on kim tra.
Ngy p dng:

-5-

Ln sa i: 00

QT.QLD.GDP

- Nu tm tt phng php v trnh t ca cuc kim tra, d kin s

ngy kim tra cho c s v thi gian d kin kt thc.
C s gii thiu bo co:
- C s trnh by cc lnh vc lin quan n vic trin khai GDP ca
c s. Vi ngh c s trnh by khng qu 60 pht
Trao i gia on kim tra vi cng ty: Sau khi cng ty trnh by xong
- on kim tra nu cc cu hi v cc thc mc khi cng ty trnh
by. C s gii p
- Vic trao i cung cp nhng thng tin cn thit on c c s
i kim tra thc t
Sau khi c cuc hp vi cng ty, trng on ngh kim tra thc t.
5.2.10.2 Kim tra thc t:
- Kim tra iu kin thc t
- Kim tra h s ti liu ghi li cc hot ng ca cng ty: Sau khi
kim tra thc t, trng on phn cng cc thnh vin trong on
kim tra cc loi h s v ti liu theo yu cu ca GDP.
Vic kim tra thc t c tin hnh theo danh mc kim tra thc hnh tt
phn phi thuc. Khi kim tra thc t, nhng vn pht hin c trong
khi kim tra khng ph hp vi nhng nguyn tc ca GDP u phi ghi
chp li trong s tay ca ngi kim tra.
5.2.10.3 Hp on kim tra v son tho bin bn:
Sau khi xem xt h s cng nh thc t, trng on triu tp cuc
hp ring on kim tra tho lun, soan tho v hon thin bin bn.
Cc thnh vin trong on a ra nhng pht hin cc vn tn ti, cng
tho lun thng nht d tho bin bn v kt lun.
- Tt c nhng nhn xt ca on kim tra v u im v tn ti ca
cng ty c th k tp hp vo bin bn. Bin bn kim tra c
trng on, th k on v v ch c s hoc ngi qun l
chuyn mn c mt ti thi im kim tra k xc nhn theo biu
mu (Biu mu nh km). Ngoi ra th k cn phi k nhy vo
tng trang ca ton b bin bn. Sau cng ty gi mt b, on
kim tra gi hai b cng vi check list c k nhy nh km.
on kim tra phn loi t GDP ca cc c s cc mc nh sau:
- Mc A: C s t theo yu cu ca tiu chun GDP (v cn khc
phc mt s tn ti nu c). Trng hp ny s c cp giy
chng nhn ngay.
- Mc B: C s phi bo co nhng khc phc cc tn ti ghi
trong bin bn km cc h s bo co hoc nh chp v S Y t.
Trong bo co phi m t c nguyn nhn, bin php khc phc
nhng tn ti, cc bin php ngn chn s lp li nhng tn ti v
nu r thi gian hon thnh. Vic kim tra nhng khc phc c th
Ngy p dng:

-6-

Ln sa i: 00

QT.QLD.GDP

thc hin bng vic xem cc h s bo co, hnh nh hoc kim tra
li thc t. Sau khi xem xt bo co khc phc, on kim tra s
trnh lnh o SYT quyt nh vic cp giy chng nhn.
- Mc C: C s kim tra khng t cc nguyn tc tiu chun GDP.
5.2.10.4 Hp vi cng ty thng bo kt qu kim tra:
Sau khi thng nht d tho bin bn kim tra, on kim tra hp cng vi
cng ty thng bo kt qu kim tra do trng on ch tr:
- Trng on kim tra c d tho bin bn
- Trong khi c d tho:
Trng on cn nu r nhng tn ti hoc gii thch c th
hn cc tn ti m cng ty mc phi
Tho lun gia on kim tra v c s v cc tn ti v c
th nu ra c bin php khc phc nu c.
kin ca c s: (sau khi trng on c d tho) kin ca c s
c ghi v thng nht vo bin bn.
5.3 X l sau khi kim tra:
Nhng c s c phn loi mc A: Khi on kim tra trnh bin
bn km quyt nh v giy chng nhn GDP ln lnh o SYT quyt
nh.
Nhng c s c phn loi mc B, sau khi khc phc c s t kim
tra nh gi t yu cu GDP, trong vng 2 thng c s gi bo co khc
phc v SYT. Sau khi xem xt kim tra nhng khc phc, nu thy t
yu cu, th k on v trng on s trnh bin bn, h s khc phc
km quyt nh v giy chng nhn GDP ln lnh o SYT quyt nh.
Nu qu thi gian bo co khc phc qu hai thng, c s phi c vn bn
gii trnh nu r l do gi km theo bo co.
C s phn loi mc C (khng t nhng yu cu c bn ca GDP):
Th k on s son tho cng vn, trnh trng on k nhy v trnh
lnh o S Y t tr li c s. on kim tra s t chc kim tra li sau
khi c s khc phc cc tn ti trong bin bn v np h s ng k
kim tra li.
6. H S CA QUY TRNH
- Chuyn vin th l h s s phi thc hin nhng vic sau: vo cc danh
sch lin quan c lu cc File trong my tnh ti phng chc nng.
- Th k on kim tra h s : n ng k kim tra GDP, quyt nh
kim tra, bin bn kim tra GDP ca c s, quyt nh cp giy chng nhn,
giy chng nhn GDP chuyn cho chuyn vin th l h s lu h s ti phng
chc nng.
7. PH LC
Lit k v km theo cc biu mu/ph lc km dng trong quy trnh.
- BM.QLD.GDP.01: Bin bn kim tra GDP
-7Ngy p dng:

Ln sa i: 00

BM.QLD.GDP.01

S Y t

bin bn kim tra

"thc hnh tt Phn phi thuc "
Tn c s:...............

Ngy ../.../....

BM.QLD.GDP.01
Y BAN NHN DN TNH
S y t

cng ho x hi ch ngha vit nam

c lp - T do - Hnh phc
, ngy thng nm 20

bin bn kim tra

"thc hnh tt Phn phi thuc "
Cn c Quyt nh s .......... ngy ......... ca .........v vic thnh lp on
kim tra trin khai p dng cc nguyn tc "Thc hnh tt phn phi thuc" ca
B Y t ti ....., thnh phn on kim tra gm :
1............ - Trng on.
2................ - Th k.
3.................

Tn c s:
- a ch:
- Ngi chu trch nhim:
- Bn ng k kim tra ngy . ca
- Ngy tin hnh kim tra: .
- Ni dung kim tra: vic trin khai p dng cc nguyn tc, tiu chun "Thc
hnh tt phn phi thuc" ca B Y t
- Tip on c :
1........
2..........
3.......
I/ Mt s kin ca on kim tra:

Sau khi thm nh h s, nghe bo co ca Cng ty v tin hnh kim tra

thc t, on kim tra c mt s kin sau:
A. u im:
1. T chc v qun l:..........
2. Nhn s:.........
3. Qun l cht lng: ....
4. C s kho tng v bo qun: ...
5. Phng tin vn chuyn v trang thit b: .....
6. Bao b v nhn trn bao b: .....
7. Giao hng v gi hng: .....
8. Vn chuyn thuc trong qu trnh vn chuyn: ....
9. H s ti liu: .....
10. ng gi li v dn nhn li: .....
1

BM.QLD.GDP.01
11. Khiu ni: .....
12. Thu hi: ....
13. Sn phm b loi v b tr v: ....
14. Thuc gi: ....
15. Nhp khu: ....
16. Hot ng theo hp ng: ....
17. T kim tra: ......
B. Tn ti:
1. T chc v qun l:..........
2. Nhn s:.........
3. Qun l cht lng: ....
4. C s kho tng v bo qun: ...
5. Phng tin vn chuyn v trang thit b: .....
6. Bao b v nhn trn bao b: .....
7. Giao hng v gi hng: .....
8. Vn chuyn thuc trong qu trnh vn chuyn: ....
9. H s ti liu: .....
10. ng gi li v dn nhn li: .....
11. Khiu ni: .....
12. Thu hi: ....
13. Sn phm b loi v b tr v: ....
14. Thuc gi: ....
15. Nhp khu: ....
16. Hot ng theo hp ng: ....
17. T kim tra: ......
II/ Kt lun:

III/ kin ca C s.
.............................
Bin bn c thng nht gia on kim tra v Cng ty ........
Bin bn ny c lm thnh ba bn. Cng ty gi mt bn, S Y t gi hai
bn. (S Y t gi mt bn, Cc Qun l Dc gi mt bn nu Cc Qun l Dc
c tham gia thnh phn on)
on kim tra
Th k

Trng on

n v c kim tra
Gim c