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 Ni dung 1 Tn c s: a ch: S in thoi: Fax: Email: 2 Tn ch c s/ ngi qun l hot ng chuyn mn Giy chng nhn iu kin kinh doanh thuc: 3 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 Tham chiu C Khng Nhn xt
t Khng t
1 2 3 4 5 6 7 I Nhn s 1.1 Ch c s (hoc ngi ph trch chuyn mn)
1.1.1 C mt khi c s bn l hot ng hoc thc hin u quyn theo quy nh? III.4b 1.1.2 C trc tip tham gia bn thuc phi k n? III.4b 1.1.3 C kim sot cht lng thuc khi nhp v v trong qu trnh bo qun ti nh thuc? III.4b 1.1.4 C thng xuyn cp nht kin thc chuyn mn (tham gia cc lp tp hun, bi dng chuyn mn....)? III.4b 1.1.5 C o to hng dn nhn vin? III.4b 1.1.6 C theo di cc tc dng khng mong mun v thng bo vi c quan y t ? III.4b 1.1.7 C cng tc vi y t c s ? III.4b
1 TT Ni dung Tham chiu C Khng Nhn xt t Khng t
1.1.8 Thc hin vic nim yt gi thuc v bn theo gi nim yt?. III.4b (0 c)
1.2 Ngi bn l
1.2.1 C nhn vin phc v cho hot ng ca nh thuc? S lng nhn vin: Dc s i hc:......... Dc s trung hc:......... Dc t:...... Cc bng cp khc: I.2
1.2.2 Bng cp chuyn mn v thi gian 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?
I.1.3
1.2.3 C mc o Blu v eo bin hiu ghi r chc danh? III.4a
1.2.4 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? III.4a
1.2.5 C thi ho nh, lch s khi tip xc vi khch hng? III.4a
1.2.6 C gi b mt thng tin v ngi bnh? III.4a
2 TT Ni dung Tham chiu C Khng Nhn xt
t Khng t
II C s vt cht k thut 2.1 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? II.1 2.2 Din tch v b tr : Tng din tch c s: Din tch ph hp vi quy m kinh doanh ( ti thiu 10m2)? II.2a 2.3 C khu vc trng by? II.2a 2.4 C khu vc bo qun thuc?
2.5 C khu vc ngi mua thuc tip xc v trao i thng tin? II.2a 2.6 C ni ra tay? C ni ra dng c pha ch? II.2b, 2d 2.7 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? II.2b
2.8 M phm, thc phm chc nng, dng c y t c khu vc ring, khng nh hng n thuc? II.2c
III Trang thit b 3.1 Thit b bo qun thuc
3 TT Ni dung Tham chiu C Khng Nhn xt t Khng t
3.1.1 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? II.3a, 3b 3.1.2 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 30 o C, m bng hoc di 75%)? II.3a, 3b
3.2 Dng c, bao b ra l v pha ch theo n :
3.2.1 C bao b ra l thuc? II.3c 3.2.2 Trng hp thuc khng cn bao b tip xc trc tip th bao b c kn kh? II.3c 3.2.3 Thuc dng ngoi v thuc qun l c bit c c trong bao b d phn bit? II.3c 3.2.4 Thuc bn l c ng trong bao b mang tn thuc khc hoc cha ni dung qung co ca mt thuc khc? II.3c 3.2.5 Thuc pha ch theo n ng trong bao b dc dng? II.3c 3.2.6 Dng c ra l v pha ch theo n c ph hp v d lau ra, lm v sinh?
II.3
4 TT Ni dung Tham chiu C Khng Nhn xt t Khng t
3.2.7 C thit b tit trng cc dng c pha ch thuc theo n? II.3 IV Ghi nhn thuc 4.1 Thuc bn l khng ng trong bao 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? II.3d 4.2 Thuc pha ch theo n, ngoi quy 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)? II.3d V h s s sch v ti liu chuyn mn 5.1 H s php l : 5.1.1 C chng ch hnh ngh dc? I.1 5.1.2 C h s nhn vin? I.3 5.2 Ti liu hng dn s dng thuc : 5.2.1 C ti liu hng dn s dng thuc? II.4a 5.2.2 C cc quy ch chuyn mn dc hin hnh? II.4a 5.3 H s s sch lin quan hot ng kinh doanh thuc :
5 TT Ni dung Tham chiu C Khng Nhn xt t Khng t
5.3.1 Theo di s l, hn dng thuc v 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?
II.4b 5.3.2 C Theo di d liu lin quan n 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? II.4b 5.3.3 Theo di vic kinh doanh bo qun thuc gy nghin, thuc HTT v tin cht : - Theo di bng my tnh? - Theo di bng s? II.4b 5.4 Xy dng v thc hin cc quy trnh thao tc chun :
5.4.1 Cc hot ng chuyn mn ti c s c c m t v quy nh di dng vn bn mi ngi trong c s bn l c th c v p dng? II.4c 5.4.2 C cc quy trnh c bn theo yu 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?
II4.c
6 TT Ni dung Tham chiu C Khng Nhn xt t Khng t
5.4.3 C cc quy trnh khc? (lit k) II.4c 5.4.4 Cc quy trnh thao tc chun lin quan n cc hot ng chuyn mn ca c s c do ngi ph trch chuyn mn ph duyt v k ban hnh khng? Ph lc 2
5.4.5 Nhn vin bn thuc c p dng thc hin y cc quy trnh? II.4c VI Ngun thuc 6.1 C h s cc nh cung ng thuc c 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)? III.1a 6.2 Nh thuc c y cc loi thuc dng cho tuyn C trong Danh mc thuc thit yu Vit Nam (do SYT quy nh)? III.1 VII Thc hin quy ch chuyn mn THc hnh ngh nghip 7.1 Thuc gy nghin, thuc hng tm thn v tin cht c khu vc ring hoc t ring? III.4a 7.2 Mua bn thuc gy nghin, thuc 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 ?
III.4a
7 TT Ni dung Tham chiu C Khng Nhn xt t Khng t
7.3 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? III.4a 7.4 Kim tra i chiu s lng thuc GN, thuc HTT, tin cht trn s sch v thc t c khp ? III.4a 7.5 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? III.2a 7.6 Ngi bn l c trnh chuyn mn ph hp bn cc thuc k trong n thuc khng? C kim tra n thuc trc khi bn? 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? III.2c 7.7 Khi bn thuc, ngi bn l c t 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?
III.2
8 TT Ni dung Tham chiu C Khng Nhn xt t Khng t
7.8 Hng dn s dng thuc c va bng li ni, va ghi nhn theo quy nh? III.2a 7.9 Khi giao thuc cho ngi mua, ngi 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? III.2a 7.10 Ngi bn l, c s bn l c tin 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)? Ngi bn l thuc c khuyn khch ngi mua mua nhiu thuc hn cn thit khng? III.2b 7.11 Thuc c nhn? III.1c 7.12 Nhn thuc v thuc bn trong ng v khp vi nhau? III.1c III.3
7.13 Sp xp thuc: - 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?
VIII Kim tra/ m bo cht lng thuc 8.1 Khi nhp thuc, ngi bn l c 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?
III. 1c v III.1d
9 TT Ni dung Tham chiu C Khng Nhn xt t Khng t
8.2 Trong c s c cc loi thuc sau 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? III.1c
IX Gii quyt i vi thuc b khiu ni hoc thuc phi thu hi 9.1 C tip nhn thng tin hoc lu cc thng bo v thuc khiu ni, thuc khng c php lu hnh, thuc phi thu hi ? III.3c 9.2 C kim k i vi thuc khiu ni, thuc phi thu hi? III.3c 9.3 C thng bo thu hi cho khch hng ? III.3c 9.4 C thu hi v lp h s thu hi theo quy nh? III.3c 9.5 C tr li ni mua hoc hu? III.3c 9.6 C bo co cc cp theo quy nh? III.3c 9.7 C s theo di tc dng ph ca thuc do khch hng phn nh? III.3b
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.
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QUY TRNH CP GIY CHNG NHN T TIU CHUN THC HNH TT NH THUC (GPP)
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Ngi vit Ngi kim tra Ngi ph duyt H v tn K
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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
S Y T.....
QUY TRNH CP GIY CHNG NHN T TIU CHUN THC HNH TT NH THUC (GPP)
M s: QT.QLD.GPP
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- 2 - 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
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Ngi thc hin Trnh t thc hin Ti liu tham chiu, biu mu C s bn l 5.2.1
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5.2.2 Lnh o SYT 5.2.3 Lnh o Phng 5.2.4 CV c phn cng
5.2.5
CV, Lnh o Phng, Lnh o SYT
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on thm nh
5.2.7 BM.QLD.GPP.01 CV, Lnh o Phng, Lnh o SYT
5.2.8 Lnh o SYT 5.2.9 Vn th SYT, 5.2.10 H s ngh , h s b sung Nhn, Trnh lnh o S Phn chuyn phng chc nng Nhn h s, Phn cng gii quyt Phiu tip nhn HS y HS thiu Quyt nh thnh lp on thm nh Yu cu b sung D tho GCN Vn bn tr li Thm nh Kt lun Khng t t Yu cu b sung ng du, chuyn c s, Lu h s K Duyt
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- 4 - 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
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- 5 - 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
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- 6 - 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
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S Y t......
bin bn kim tra "thc hnh tt nh thuc "
Tn c s:................................................... a ch: ...................................................... Ngi qun l chuyn mn:.....................
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, 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...)
QT.QLD.GPP
Ngy p dng: Ln sa i: 00
- 9 - 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 on kim tra Ngi qun l chuyn mn Th k Trng on
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: 1 * Tn n v:
* a ch n v: .................................................................................................................................. * S din thoi:..............................Fax:...................................Email:............................... 2 * Tn v chc danh ngi gim c hoc ph trch n v:
3 * Tn v a ch ca c s phn phi thuc: .................................................................................................................................. 4 * Tn v trnh ca ngi ph trch c s phn phi thuc: .................................................................................................................................. 5 * C s thuc: - Doanh nghip sn xut - Doanh nghip bun bn thuc - i tng khc 6 * 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................................................... 7 * S lng nhn vin theo nghip v - Sau i hc - Dc s - K thut vin - Dc t - i hc khc
C TT Ni dung Tham chiu t Khng t Khng Nhn xt T chc, qun l v nhn s 1 C s c t cch php nhn khng? II.1.a 2 C s t chc nhn s khng? S c ghi r tn, trnh ca tng II.1.b - 1 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt ngi khng? 3 C vn bn quy nh trch nhim quyn hn ca tng c nhn v mi quan h gia cc c nhn khng? II.1.d 4 C s c y nhn vin c trnh ph hp vi cng vic c giao khng? II.1.c II.2.b,c
5 C bn m t cng vic ca tng c nhn khng? II.1. 6 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 7 C s c cc quy nh v an ton lao ng ca nhn vin v ti sn khng? II.1.g 8 C quy trnh v thit b s cu x l cc trng hp nh hng n s an ton ca nhn vin khng? II.2.h 9 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. - 2 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt 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 nhn vin ph hp vi cc hot ng tin hnh khng? II.2.g 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 thc hin theo ng cc quy trnh ban hnh khng? II.3. 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 TT Ni dung Tham chiu t Khng t Khng Nhn xt 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: - 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,... II.4.a
Khu vc bo qun 31 C bng ni quy ra vo v cc bin php cn thit hn ch vic ra vo khu vc bo qun khng? II.4.b 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 c trn gi k khng? II.4. 35 Gi k bo qun thuc c trong tnh trng tt, sch s khng? II.4. 36 Khong cch gia cc gi, k c rng d dng lm v sinh v kim tra thuc khng? II.4. 37 C cc quy trnh lm v sinh v phng php v sinh bng vn bn cho khu vc bo qun khng? II.4.e - 4 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt 38 C cc quy trnh bng vn bn v bin php kim sot cn trng khng? II.4.e 39 Cc dng c, ha cht kim sot cn trng c gy nguy c tp nhim i vi hng ha c bo qun khng? II.4.e 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 thit k, xy dng v trang b ph hp c th lm sch bao b trc khi nhp kho khng? II.4.h 44 Khu vc tip nhn, cp pht c kh nng bo v thuc khng b nh hng xu ca thi tit v cc ngun nhim khc khng? II.4.h 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 II.8.l
49 Cc thuc b loi b c c dn nhn r rng v c kim sot khng? II.4.o - 5 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt 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: - Bo qun nguyn liu, t dc lm thuc - Bo qun vc xin v sinh phm y t II.4.l 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 di lin tc cc iu kin bo qun (nhit , m) khng? II.4.l 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 TT Ni dung Tham chiu t Khng t Khng Nhn xt (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 v b tr m bo phng chy cha chy khng? II.4.r 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 c c ghi li khng? II.4.u 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 b bo qun, thit b theo di iu kin bo qun c c ghi li v nh gi nh hng ti cht lng II.4.v - 7 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt 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 chuyn c bo v c thuc v bao b khi cc tc nhn bn ngoi v s nhim bn khng? II.5.a 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 II.5.i
76 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 II.5.g
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 II.5.k
79 C nh gi ng u nhit trong cc phng tin bo qun ny khng? II.5.c II.5.k
80 iu kin bo qun c c duy tr II.5.c - 8 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt 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 II.8. 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.5.k II.5.l
83 Cc phng tin vn chuyn theo hp ng c c nh gi khng? Cc iu kin bo qun trong qu trnh vn chuyn c c theo di v ghi li khng? II.5.c II.5.k
84 Trong qu trnh vn chyn c thc 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? II.5.k 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 TT Ni dung Tham chiu t Khng t Khng Nhn xt v trang thit b khng? 89 C quy trnh bng vn bn v bin 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? II.5.h 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 II.8.o
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. - 10 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt 99 Nu s dng nc kh t trong bao b thuc, c m bo rng thuc khng tip xc vi nc kh khng? II.6.e 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: - 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 II.7. 106 H s giao hng-gi hng c c II.7.e - 11 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt 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 II.8.d
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 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 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? II.8.c - 12 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt 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 cu bo qun c bit khc vi iu kin mi trng bit c c m bo, c theo di v ghi chp li khng? II.8. 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 chuyn dng v bo m an ninh i vi cc thuc trn khng? II.8.h II.8.i II.8.m
125 C quy trnh x l cc thuc b trn, b ngn nga tp nhim, nhim cho v nguy c khc khng? II.8.k 126 Bn trong ca cc phng tin v II.8.n - 13 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt 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 theo trong sut qu trnh vn chuyn thuc khng? II.8.s 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: - 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. II.9.c 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 sot v r sot, kim sot thay i i vi cc ti liu lin quan khng? II.9.d 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 TT Ni dung Tham chiu t Khng t Khng Nhn xt 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 ng quy nh ca php lut khng? II.9.k
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 tr an ton khng? C sn sng cho vic truy cp khi cn thit khng? II.9.m 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 TT Ni dung Tham chiu t Khng t Khng Nhn xt 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 vc ring dnh cho vic dn nhn ph, b sung t hng dn khng? II.10.b 148 Khu vc ny c m bo: - 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 II.10.b 149 L sn phm c c cung cp phiu kim nghim ca nh sn xut gc v phiu kim nghim mi (nu c) khng? II.10.c 150 Cc thng tin v sn phm trn phiu kim nghim mi c cho php vic truy li phiu kim nghim gc khng? II.10.c 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 bo duy tr cht lng thuc trc v sau khi ng gi li khng? II.10.d Khiu ni 153 C cc quy trnh bng vn bn x l khiu ni khng? II.11.a 154 C quy trnh x l bng vn bn xem xt cc khiu ni, thng tin lin quan n thuc km cht lng II.11.b - 16 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt 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 hi nhanh chng v hiu qu khng? C ch r ngi chu trch nhim chnh khng? II.12.a 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 bo v phi hp cht ch vi nh sn xut gc khng? II.12.c 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 TT Ni dung Tham chiu t Khng t Khng Nhn xt qun ring bit hay dn nhn phn bit trong qu trnh vn chuyn khng? 167 iu kin bo qun cc thuc b loi b v sn phm thu hi trong qu trnh bo qun v vn chuyn c c duy tr cho n khi c quyt nh cui cng khng? II.12.g II.13.a
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 thuc loi b, thuc tr v c c thc hin bi ngi c phn cng khng? II.13.b 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: - 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. II.13.c - 18 - C TT Ni dung Tham chiu t Khng t Khng Nhn xt 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 vn chuyn cc thuc b loi c m bo an ton v ph hp trc khi x l khng? II.13.e 177 Thuc c c hy theo ng quy nh khng? C h s thu hi thuc, bo co thu hi v bin bn hy thuc theo quy nh khng? II.13.g 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 gi c pht hin khng? II.14.a 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 TT Ni dung Tham chiu t Khng t Khng Nhn xt 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 tun th cc nguyn tc: Thc hnh tt phn phi thuc khng? II.16.b 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 TT Ni dung Tham chiu 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 lp v chi tit khng? II.17.b 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/Q- BYT ngy 24 thng 1 nm 2007 ca B trng B Y t.
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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 Ngi kim tr a Ngi ph duyt H v tn K
QT.QLD.GDP
Ngy p dng: Ln sa i: 00
- 1 -
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 ) Tr ang Hng mc sa i Tm tt ni dung hng mc sa i
S Y T
QUY TRNH
M s: QT.QLD.GDP
Ngy ban hnh: CP GIY CHNG NHN
THC HNH TT PHN PHI THUC (GDP)
Ln sa i:
Tng s trang:
QT.QLD.GDP
Ngy p dng: Ln sa i: 00
- 2 - 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 tr nh cp giy chng nhn GDP:
QT.QLD.GDP
Ngy p dng: Ln sa i: 00
- 3 - Tr ch nhim S qu tr nh thc hin M t/Biu mu
Vn th SYT v vn th phng chc nng 5.2.1 Trng phng
5.2.2
Chuyn vin thm nh
5.2.3
Lnh o phng
5.2.4 Chuyn vin Lnh o phng
5.2.5 Lnh o S Y t
5.2.6 Th k on kim tra
5.2.7 Lnh o S Y t
5.2.8 Chuyn vin Th k
5.2.9 an kim tra 5.2.10 BM.QLD.GDP.01 Th k Trng on Lnh o phng Lnh o cc
5.3
6
ngh Tip nhn h s Phn cng Thm nh h s Xem xt Chun b KH kim tra Xem xt Hon thin KH Ph duyt Chun b kim tra Kim tra c s X l sau kim tra Lu h s
QT.QLD.GDP
Ngy p dng: Ln sa i: 00
- 4 - 5.2 M t s qu tr nh qu tr nh 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/TT- BYT 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:
QT.QLD.GDP
Ngy p dng: Ln sa i: 00
- 5 - - 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.
QT.QLD.GDP
Ngy p dng: Ln sa i: 00
- 6 - - 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 tr a 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 tr a 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
QT.QLD.GDP
Ngy p dng: Ln sa i: 00
- 7 - 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 BM.QLD.GDP.01 0
S Y t
BIN BN KIM TRA "THUC HNH TT PHN PHI THUC "
Tn c s:...............
Ngy ../.../....
BM.QLD.GDP.01 Y BAN NHN DN TNH cng ho x hi ch ngha vit nam S y t 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)