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2/23/2014

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I CNG
Mc tiu hc tp
Trnh by nh ngha thuc v cc yu cu BCL
thuc
Trnh by h thng t chc, qun l, kim tra cht
lng thuc ti Vit Nam
Trnh by ni dung cng tc tiu chun ha
Trnh by cc ni dung chnh ca KTCL thuc:
-Ly mu
-Kim nghim
-Vit phiu & tr li kt qu
Ni dung chnh ca GLP
Cht lng thuc v m bo cht lng
Khi nim v thuc
WHO
iu l thuc phng bnh, cha
bnh (24/1/1991)
nh ngha chnh thc
v thuc ti Vit Nam
Ngun gc: ng vt, thc vt, khong
vt, sinh hc
i tng s dng: con ngi
Mc ch s dng:
- Phng, cha bnh
- Phc hi, iu chnh chc nng
- Lm gim triu chng
- Chn on
- Phc hi, nng cao sc khe
- Lm mt cm gic mt b phn hay ton thn
- Lm nh hng qu trnh sinh sn
- Lm thay i hnh dng c th
- Vt liu nha khoa, bng bng, ch khu y t
THUC
Cht lng thuc v m bo cht lng
Cht lng thuc
Tng hp cc tnh cht c trng ca thuc (nh
tnh, nh lng, tinh khit, nhn, bao gi)
Th hin mc ph hp vi yu cu k thut
nh trc ty theo iu kin kinh t, k thut,
x hi
m bo t cc mc ch:
- C hiu lc
- Khng hoc t tc dng c hi
- n nh v cht lng trong thi hn xc nh
- Tin dng, d bo qun
Cht lng thuc v m bo cht lng
Yu cu cht lng thuc
- ng thnh phn theo t l quy nh ca cng thc
ng k v c cp php (nh tnh, nh lng)
- c php SX v SX ng quy trnh ng k
v c cp php
- Tinh khit t quy nh
- ng gi trong ng, bao gi vi nhn
thch hp, ng quy cch ng k
- c bo qun, phn phi, qun l ng quy
nh CL thuc c duy tr trong sut tui th
ng k hay thi hn bo hnh
Cc yu t m bo cht lng (cc GP)
Nguyn liu
Thnh phm
Sn xut
Bo qun
Phn phi
GLP
GSP
GDP
GPP
GMP
GACP
Yu t lin quan mt thit n kim nghim thuc
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Thc hnh tt sn xut thuc (GMP)
Cc quy nh cht ch, chi tit v mi mt
qu trnh sn xut sn xut thuc:
- Thnh phn theo d kin
- t tiu chun k thut t ra
Yu cu
- Quy trnh sn xut
- Con ngi
- C s vt cht
- Kim tra, theo di trong qu trnh sn xut
- H thng h s sn xut, phn phi
- C ch thu hi sn phm
Thc hnh tt phng KN thuc (GLP)
Cc quy nh cht ch, chi tit v mi mt
qu trnh KTCL thuc:
- m bo kq chnh xc, khch quan.
Yu cu
- Con ngi
- C s vt cht
- Ha cht, thuc th, cht chun
- iu kin v sinh
- Ly mu, lu mu
- Th nghim, x l s liu
- Lu tr h s
Thc hnh tt bo qun thuc (GSP)
Cc quy nh cht ch, chi tit v mi mt
qu trnh tn tr, iu kin bo qun, xut
nhp nguyn ph liu, bao b, thnh phm,
nhn m bo CL thuc n ngi sd.
Yu cu
- Con ngi
- C s vt cht
- iu kin v sinh
- Quy trnh bo qun, vn chuyn
Thc hnh tt nui trng, thu hi DL (GACP)
Yu cu
- Nhn dng, xc nh ngun gc cy thuc
- Ging, vt liu nhn ging
- Trng trt, thu hi, ch bin, tn tr
- Con ngi
- C s h tng, trang thit b
- H s, ti liu
Cc quy nh trong nui trng, thu hi dc
liu c ngun nguyn liu tho dc cht
lng tt, an ton mt cch bn vng, bo
tn ngun dc liu v mi trng.
Kim tra cht lng thuc
Mc tiu
- Ngi s dng dng c thuc m bo cht
lng, t hiu qu s dng cao
- Pht hin thuc khng t tiu chun, thuc gi,
thuc km phm cht x l
Quy nh
Tt c thuc v NL lm thuc u phi c KN
v xc nh cht lng, nu t tiu chun quy
nh mi c a vo s dng
Kim tra cht lng thuc
Khi nim:
KTCL thuc (KN thuc) l vic s dng cc pp phn
tch xc nhn mt thuc hay nguyn liu t hay
khng t tiu chun quy nh.
- C phi l thuc cn kim tra khng?
- C m bo hot lc, hm lng ng k khng?
- C t tinh khit yu cu khng?
- C b bin cht, phn hy khng?
- bao gi, nhn c ng quy cch khng?
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Kim tra cht lng thuc
Yu t nh hng
- Ri ro, nhm ln, khng chp hnh quy nh
GMP
- Sn phm c hm lng thp hn quy nh do
v tnh hay c trong SX
- Cng thc, k thut bo ch cha ng lm
thuc b phn hy, bin cht
- Qu trnh bo qun cha tt
- Thuc gi
Thuc t, khng t tiu chun
Thuc t tiu chun
p ng y cc yu cu KT ca TC
ra (hay p ng y cc mc cht lng
trong TCCL ng k)
Thuc khng t tiu chun
p ng khng y cc yu cu KT
ca TC ra hay ng k (c th khng
t mt hay nhiu ch tiu). Thuc khng t
TC thuc loi thuc km cht lng.
Thuc gi, thuc km phm cht
Thuc gi
- Khng c hot cht hoc hm
lng khng m bo
- Cha dc cht khc vi trn
nhn
- Nhi kiu dng cng nghip
Thuc gi, thuc km phm cht
Thuc km phm cht
Khng t tiu chun trc
t v nhiu nguyn nhn khc
nhau:
- Sn xut, bo qun
- Nguyn liu, bao b
- Qu hn SD
- Mi trng
Trung ng a phng
- Vin KNTTW
- Vin KNT Tp.HCM
Cc TTKN thuc, m phm
tnh, thnh ph
H thng KTCL
H THNG QUN L, KIM TRA CHT LNG THUC
Doanh nghip,
CSSX
Phng Kim nghim, KCS
Phng nghip v Dc
B Y t
S Y t cc tnh, thnh ph
Cc Qun l Dc
H thng QLCL thuc
Cc QLD
Xy dng quy hoch, ln k hoch v QLCL thuc,
t chc thc hin k hoch c ph duyt
Xy dng vn bn php quy v TC& CL thuc
BYT ban hnh, hng dn, kim tra vic thc hin
Qun l ng k TCCS. Cung cp TT v BCL thuc
Ch o, gim st h thng KTCL thuc trn ton
quc
Kim tra, cp giy chng nhn GMP, GLP
T chc hng dn nghip v cho CBQLCL, o
to bi dng nghip v v TC- L- CL thuc
Phi hp thanh tra BYT thc hin chc nng
kim tra, thanh tra NN v CL thuc, x l vi phm
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H thng QLCL thuc
Ph bin, hng dn, t chc thc hin cc vn
bn PL v QLCL thuc ti a phng.
Thc hin chc nng kim tra, thanh tra NN v CL
thuc, x l vi phm v CL thuc trong phm vi
a phng
Phng
Nghip v
Dc
S y t
H thng KTCL thuc
Nghin cu xy dng TCVN v thuc (DVN).
Kim tra, xc nh CL thuc trn th trng
Vin KNT
Tp.HCM
Vin KNT
TW
Thm tra KT, gip BYT xt duyt TCKN cp
ng k SX v lu hnh thuc ti VN
Pht hnh cht chun, cht i chiu cho KN
Lm trng ti v CL khi c tranh chp khiu ni v CL
thuc
Tham gia o to CB lm cng tc KN
T vn v chnh sch CL thuc QG
Xy dng TC PKN t GLP, gip , kim tra cng
nhn GLP trong c nc
Kim tra vic KN thuc theo TC trong c nc
H thng KTCL thuc
Nhim v gii hn trong phm vi tnh, thnh ph
TTKN
tnh,
thnh ph
H thng
t KTCL
ca c s
Xy dng TCCS cho cc sn phm do c s SX
Kim tra nguyn liu, bao b, bn thnh phm,
thnh phm
Cng tc tiu chun ho
Tiu chun ha:
Mt lnh vc hot ng gm 2 ni dung
Xy dng ra cc tiu chun
p dng TC trong thc t
Mc tiu
a hot ng XH (SX, KD) vo n np
t hiu qu chung c li nht cho mi
ngi & XH
Cng tc tiu chun ho
Tiu chun:
Nhng quy nh thng nht v hp l
c trnh by di dng vn bn hoc th
thc nht nh
Do mt c quan c thm quyn ban hnh
Bt buc p dng cho nhng ni c lin quan
TC
Vn bn php ch
Quy nh thng nht, hp l
Bt buc p dng nhm BCL mt s/p
Cng tc tiu chun ho
Cht lng sn phm:
Mt tp hp nhng ch tiu c trng
Th hin tnh nng s dng
Nhm tha mn yu cu xc nh trc
cho sn phm trong nhng iu kin xc
nh
Ph hp vi hon cnh kinh t, k thut, XH
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Cng tc tiu chun ho
Tiu chun thuc:
Vn bn KHKT mang tnh php ch quy nh
Quy cch
Ch tiu yu cu KT
Phng php th
ng gi- ghi nhn- bo qun
Cc vn lin quan khc
Cng tc tiu chun ho
Tiu chun thuc:
L c s c s KN
Tin hnh thc nghim
nh gi kt qu
Cng b kt qu (Phiu KN)
nh gi CL thuc t hay khng t, c
c php lu hnh khng
Tiu chun thuc
Edwin Smith Papyrus
(Ai Cp)
Dc in Vit Nam IV (2010)
1500 T.C.N
1617 : London Pharmacopoeia
1864 : British Pharmacopoeia
1820 : USP
1971: DVN I
2010: DVN IV
Lch s
Cng tc tiu chun ho
i tng
-Thit b, dng c, my mc
-Sn phm, hng ha
-Nguyn vt liu
-Nguyn tc, th tc, phng php
-Thut ng, o lng, k hiu
Tiu chun thuc
L mt TC ton din, gm nhiu ni dung
Th hin mc CL thuc c to ra v duy tr
cho ti khi s dng hoc ht tui th
NI DUNG CHNH
1.Tiu
2.Yu cu k thut
3.Phng php th
4.ng gi, ghi nhn, bo qun
Ni dung chnh ca tiu chun thuc
1
Tiu
Tn nguyn liu, thnh phm
Tn n v ban hnh TC
Loi TC
Hiu lc thi hnh
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Ni dung chnh ca tiu chun thuc
2 Yu cu k thut
ra mc CL hp l ca sn phm
(mi YCKT l 1 ch tiu hay tiu ch)
L c s cho vic:
-Lp k hoch SX
-Thc hin k hoch (s lng, CL)
-Qun l (kinh t, k thut, gi, k kt
hp ng, khiu ni)
Ni dung chnh ca tiu chun thuc
3 Phng php th
M t chi tit quy trnh th nghim,
quy trnh phn tch xc nh xem
mt ch tiu c t YCKT t ra
hay khng
Ni dung chnh ca tiu chun thuc
4 ng gi, ghi nhn, bo qun
Mi thuc lu hnh phi c nhn n n v
ng gi nh nht
Nhn phi c ni dung cn thit gip nhn
bit:
-Thuc
-Cch s dng
-Tn CSSX, SK, SKS, HD, iu kin bo qun
Phi c quy nh r
Tiu chun thuc
Cp tiu chun
Tiu chun Dc in Vit Nam (TCVN
v thuc)
Tiu chun c s:
-TCCS ca sn phm lu hnh trn th trng:
phi ng k vi CQ c thm quyn. Cc mc TC
khng c thp hn quy nh trong DVN
-TCCS ca thuc pha ch trong n v (khng
lu hnh trn th trng) do th trng V xt
duyt, ban hnh.
TCVN v thuc:
- NN y quyn cho BYT bin son, xt
duyt, ban hnh sau khi ng k ti Tng
cc LCLNNVN
- Cc TCVN v thuc c tp hp li thnh
Dc in VN
TCCS:
Do CSSX bin son, c cp c thm
quyn duyt
Cng tc xy dng tiu chun Cng tc xy dng tiu chun
Th tc xy dng tiu chun
Chun b ti liu, kho st thc t, lp cng
XD d tho TC ln 1:
- Tham kho TL
- xut cc ch tiu, phng php th
- Kho st thc t v SX, s dng sn phm
- SX th, lm thc nghim phn tch cc TC d
kin
- Vit d tho TC v thuyt minh
- Lp d tho bin php p dng
- Thng qua d tho ti c s
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Cng tc xy dng tiu chun
Th tc xy dng tiu chun
Hon thnh d tho TC sau khi ly kin gp
sa cha, hon chnh h s gi CQ qun l xt
duyt
Xt duyt v ban hnh TC:
-CQ qun l cp TC no th xt duyt, ban hnh
TC .
-Trc khi xt duyt, TC phi c gi qua CQ
thm tra k thut (VKN, TTKN) v c quan php
ch (Cc QLD, phng nghip v Dc)
-Th trng BYT hoc GSYT k duyt sau khi
tham kho CQ thm tra.
Cng tc xy dng tiu chun
Th tc xy dng tiu chun
H s TC gm tt c:
- Vn bn KHKT
- Kho st NC
- Cng vn trnh duyt
- Quyt nh xt duyt
Cng tc xy dng tiu chun
Phng php xy dng yu cu k thut
Cc ch tiu ca YCKT:
- Cng dng: tinh khit, hm lng
- Tin cy, an ton: hn dng, bn
- Tm sinh l: dng bo ch, ng dng
- Thm m: ng gi, bo qun
Cng tc xy dng tiu chun
Phng php xy dng yu cu k thut
Ni dung chnh ca YCKT:
- Cng thc pha ch: phi trnh by cng thc
pha ch ca thuc, ghi r tn nguyn ph liu, s
lng (bng s, bng ch), TC nguyn ph liu
- Cht lng thnh phm: Nu r hnh thc, t/c
cm quan (hnh dng, th cht, mu sc, mi v),
cc im c bit, yu cu c trng ca dng
bo ch (sai s KL, th tch, bn c hc)
- Yu cu nh tnh, nh lng, tinh khit
Cng tc xy dng tiu chun thuc
Phng php xy dng yu cu k thut
1. La chn ch tiu: da vo
- YCKT
- Thc t
- iu kin KT Khng qu nhiu, qu t
Ni ln c trng CL
thuc
Ph hp /k c th
Cng tc xy dng tiu chun thuc
Phng php xy dng yu cu k thut
2. XD mc ch tiu:
Mc ch tiu: l gi tr c th hay
khong gi tr thuc phi t c
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Cng tc xy dng tiu chun thuc
2. XD mc ch tiu:
Ch tiu c sn trong quy nh:
- Kim tra xem xt li
- p dng hoc xut
Ch tiu cha c sn trong quy nh:
- Phi lm thc nghim a ra s liu
ph hp
Cng tc xy dng tiu chun thuc
2. XD mc ch tiu:
Phi tin hnh lm th vi mu t nht ly t 3 l
SX th hay 3 l s/p c QTSX n nh
S dng pp thng k (xt sai s, khong tin cy,
chnh xc)
Gii hn tin cy tm c qua th nghim cn cn
c thm /k kinh t, thc t quy nh mc ch
tiu a vo TC
Cng tc xy dng tiu chun thuc
2. XD mc ch tiu:
S/p ly t nhiu l, nhiu CSSX, nn chn ch tiu
TB tin tin:
: ch tiu TB nhiu CSSX t c
: ch tiu cao nht 1 c s t c
Cng tc xy dng tiu chun thuc
Phng php xy dng TC PP th
Mc ch TC ha pp th
Chn quy trnh th hoc quy trnh phn
tch khi p dng cho kt qu gn
gi tr thc nht
Cng tc xy dng tiu chun thuc
Phng php xy dng TC PP th
Phn loi quy trnh th
nh tnh: cc php th nhm chng minh
cht cn phn tch c mt trong mu th
Cch thc hin:
- Cc p/ nh tnh
- o thng s c trng ca cht cn th
(ph UV-VIS, IR, sc k)
- So snh vi cht chun i chiu
Cng tc xy dng tiu chun thuc
Phng php xy dng TC PP th
Phn loi quy trnh th
tinh khit: cc php th nhm chng
minh mu th t hay khng t mc tinh
khit
Cch thc hin:
- S dng t/c c hiu (mu sc, c...)
so snh lng tp cht c trong mu
th v mu chun, t x/ gii hn tp
c trong mu phn tch
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Cng tc xy dng tiu chun thuc
Phng php xy dng TC PP th
Phn loi quy trnh th
nh lng: cc php th nhm x/ hm
lng ca mu th (hoc t/p chnh ca mu)
hoc hm lng cc hot cht trong mu
em th
Cch thc hin:
-PP ha hc
-PP ha l, vt l
-PP sinh hc
Cng tc xy dng tiu chun thuc
Phng php xy dng TC PP th

Yu cu cht lng pp th
C tnh tin tin: pp chnh xc, chn lc cao
C tnh thc t: pp ph hp /k thc t, c
tnh kh thi cao (trang b, con ngi)
C tnh kinh t: pp t tn km m vn p
ng 2 y/c trn
C tnh an ton cao: an ton L, bo v SK
(t dng ha cht c hi, thao tc nguy
him)
0 % 100 %
chn lc vs. c hiu
c hiu
chn lc
IUPAC*
- chn lc: Mc pp c th c s dng xc
nh mt i tng phn tch c th trong hn hp hoc
nn mu m khng b nh hng t cc thnh phn
khc c c tnh tng t.
- c hiu l mc cao nht ca chn lc.
*International Union of Pure and Applied Chemistry
Pp cho php x/ ng cht cn phn tch v t chu a/h
bi s c mt ca cc cht khc trong mu th
chnh xc (Accuracy)
ng
(Trueness)
chm (lp li)
(Precision)
T (-) P (+) T (-) P (-) T (+) P (-) T (+) P (+)
= A (+) = A (-)
-Sai s:
- thu hi:
- lch chun:
- lch chun tng i:
tuyn tnh (Linearity)
Nng cht cn phn tch
i lng
tn hiu
o
nhy (Sensibility)
-Gii hn pht hin (LOD):
+ S/N: 3 ln nhiu ng nn
+ 3 ln SD mu trng
-Gii hn nh lng (LOQ):
+ S/N: 10 ln nhiu ng nn
+ 10 ln SD mu trng
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Cng tc xy dng tiu chun thuc
Phng php xy dng TC PP th

Kinh nghim tin hnh XDPP


Da trn YCKT chn XDPP th thch hp
Tham kho TL, TC tng t c
Kt hp t NC, la chn
Phi ly mu, tin hnh lm thc nghim
Vit d tho km bn thuyt minh, a ra KQ
thc nghim, x l KQ, TL tham kho
Cng tc p dng tiu chun trong thc t
Mc ch, ngha
Kim chng li KQNC khi XDTC (ch tiu ph
hp? Pp ng?)
X/ hiu qu kinh t ca TC (a/h ti SX, tiu
th s/p)
Ngn chn a thuc khng t TC ra lu
hnh, s dng.
L mt mt ca cng tc TC ha. Qua p
dng :
Pht hin thuc gi, thuc km CL. Pht hin
nguyn nhn vi phm, bin php khc phc.
Cng tc p dng tiu chun trong thc t
Cc hnh thc p dng TC trong thc t
Trong SX: thc hin ng TC SX ra thuc t TC
-Kim tra nguyn vt liu trc khi a vo SX
-Kim tra trong qu trnh SX
-Kim tra thnh phm
Trong KTCL: Th tt c cc ch tiu YCKT bng
ng pp th quy nh nh gi xem thuc
c t TC khng
Cng tc p dng tiu chun trong thc t
Cng vic phi thc hin
Ph bin, gii thch, cung cp TC ty theo cp QL:
CQ chc nng: BYT, SYT chu trch nhim cung
cp TC sau khi duyt.
CQ k thut: VKN, TTKN hng dn, gii thch
v thi hnh vic p dng TC.
Cng tc p dng tiu chun trong thc t
Cng vic phi thc hin
Lp k hoch cc bin php p dng TC:
V t chc:
- Quy nh trch nhim, quyn hn ca cc cp
QL, cc b phn thc hin
- Quy nh v con ngi
V k thut: Sot xt li trang b, ha cht, cht
chun, TT, nh xng, PTN p ng y/c ca
TC ra.
Cng tc p dng tiu chun trong thc t
Cng vic phi thc hin
Kim tra p dng TC:
Ni tin hnh:
- C s SX
- H thng KTNN: VKN, TTKN
Ni dung:
- Kim tra CSVC ca cng tc KN: TL, trang b,
PTN
- Kim tra NL, bn TP, TP, thuc lu hnh trn th
trng
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Gii thiu v Dc in Vit Nam
Mt s nt chung
DVN l mt ti liu gm
Tp hp cc TCVN v thuc (ha dc v ch phm,
huyt thanh v vaccin, dc liu, ch phm ng
dc). Mi TC gi l mt CHUYN LUN
Cc quy nh chung trong cng tc KN, pp KN
chung, ha cht, thuc th, ch th, thuc chun
dng phn tch, nh gi CL thuc
Ph lc, bng tra cu
Gii thiu v Dc in Vit Nam
Mt s quy nh chung khi s dng DVN
Tn chuyn lun: Tn chnh l tn VN, sau tn VN
l tn Latinh v tn thng dng khc (nu c)
n v o lng: Theo quy nh ca CQLNN VN
Cn chnh xc: cn trn cn phn tch c
nhy ti 0,1 mg
Ly khong: ly mt lng vi chnh khng
qu 10%
n KL khng i: chnh lch gia 2 ln cn
k tip < 0,5 mg
Gii thiu v Dc in Vit Nam
Mt s quy nh chung khi s dng DVN
Nng phn trm: khng ch dn g thm l KL/TT
Alcol: khng ch dn thm l alcol cha 96 %
(TT/TT) ethanol. Ethanol khng ch dn thm l
ethanol tuyt i.
tan:
- D tan: 1 g/ < 1 ml - Kh tan: 1 g/ >100 1000 ml
- Rt tan: 1 g/1 - 10 ml - Rt kh tan: 1 g/>1 10 L
- Tan: 1g/ > 10 30 ml
- Hi tan: 1 g/ >30 100 ml
- Thc t khng tan: 1 g/ > 10L
Gii thiu v Dc in Vit Nam
Mt s quy nh chung khi s dng DVN
Nhit :
o
C
-N/ chun: 20
o
C.
-N/ thng: 20-30
o
C.
-N/ phng: 20-35
o
C.
-N/ th mt KL do lm kh: 100 2
o
C.
Phng

php: c th khc D hay TC nhng phi


c c/x tng ng. Nu KQ khc bit ly pp
trong D hay TC l chnh thc
Hm lng: ko g/h trn: 101,0 %
Gii thiu v Dc in Vit Nam
Mt s quy nh chung khi s dng DVN
Th tinh khit:
-Tp cht l khng c trong chuyn lun D,
vn phi ghi vo KQ th.
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Mt s khi nim:
L thuc:
- Lng thuc xc nh
- Ca cng loi sn phm
- c sn xut trong mt chu k nht nh p
ng yu cu GMP
- c coi l ng nht
- c ghi bng s l ca CSSX trn bao b
2/23/2014
12
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Mt s khi nim:
Tng th:
- L ton b cc n v s/p c xt
- C th l mt l, mt s l hay mt qu trnh SX
n v bao gi:
- L dng bao gi s/p lp li trong l (thng, hp...)
n v ng gi:
- L dng c ng gi trc tip s/p (chai, v)
n v sn phm:
- L i tng quy c hay c th ca 1 lng s/p
nht nh (vin thuc, ng thuc, 1 g)
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Mt s khi nim:
Mu:
- L s /v s/p ly ra t tng th t
- Dng lm c/s c cc thng tin quyt nh v tng
th
- S /v s/p c trong l gi l c l
- S /v s/p c trong mu gi l c mu
Mu ban u:
- L mt lng s/p ca l thuc c ly trong 1 ln
1 hay nhiu /v bao gi. Mi bao gi ly 1 ln.
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Mt s khi nim:
Mu ring:
- L lng s/p c ly t cc mu ban u gp
li, trn u ca 1 /v bao gi.
Mu TBTN:
- L mt lng s/p c ra t mu chung tin
hnh cc php th quy nh (k c lm li).
Mu chung:
- L lng s/p c ly t cc mu ring ca tng /v
bao gi gp li v trn u.
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Mt s khi nim:
Mu lu:
- c ly t mu TBTN hay t mu ban u tng
ng vi lng mu th.
- Dng lu li khi cn thit hoc lm cc TN trng
ti.
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Quy nh v ly mu:
Ly mu:
- L tp hp cc thao tc nhm ly ra mt lng mu
thuc i din kim tra CL.
i tng ly mu:
- H thng t k/tr: NL, bao b, s/p trung gian. s/p cha
ng gi, thnh phm.
- H thng QLNN: Thuc, NL ang trong qu trnh lu
thng, tn tr.
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Quy nh v ly mu:
Cc trng hp ly mu:
1 T KTCL:
- Phi ly mu ton b cc l thuc ti cc CSSX, lu
tr, phn phi.
- CSSX: ly mu 100 % s l
- Vic ly mu do CB phng KTCL tin hnh, c
chng kin ca CN /v ly mu
- Th trng /v c th quy nh c th hn
2/23/2014
13
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Quy nh v ly mu:
Cc trng hp ly mu:
2 KT GSCL thuc hoc thanh tra:
u tin ly mu:
-Thuc cha bnh
-C gi tr kinh t cao
-Cht lng khng n nh
-Nghi ng v hm lng, hiu lc
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Quy nh v ly mu:
Cc trng hp ly mu:
2 KT GSCL thuc hoc thanh tra:
-Ly mu KTGSCL ca cc CSSX (10% l SX trong
nm)
-Ly mu thanh tra t xut trong t/h c thng tin v
CL thuc km, thuc khng an ton, t hiu lc, thuc
gi.
-Do thanh tra vin hoc CB c giy y nhim ca
CQKT, thanh tra thc hin, c chng kin ca CBCS
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Quy nh v ly mu:
Cc /k cn lu khi ly mu:
Ni ly mu: mi trng khng c lm nhim
bn, lm thay i t/c ca mu; khng mu t/
xu ti mi trng
Ngi ly mu: c chuyn mn; do CQ qun l
thnh lp, c Q thnh lp km theo, c o
to v k thut, nm c vn bn PL, mc trang
phc thch hp, p ng c y/c ca qu trnh
ly mu
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Phi kim tra s b l hng, nhn xt, ghi li vo
bin bn ly mu
Quyn hn: c quyn
- Y/c c s cung cp mi giy t lin quan
- Kim tra mi mu c nghi ng v CL
Trch nhim:
- Thao tc ly mu
- Th tc php l
- Vn chuyn, bn giao cho CQ kim nghim
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Quy nh v ly mu:
Cc /k cn lu khi ly mu:
Dng c ly mu: sch, kh, p ng c y/c ly mu
ng mu: p ng c y/c ly mu (sch, kh,
c nhn y )
Thao tc ly mu: thn trng, t m, quan st cn thn
Phng thc ly mu: ngi ly mu t tay ly mu,
lp bin bn, nim phong bo qun mu; phi ly ch
k xc nhn ca /v c ly mu
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Tin hnh ly mu:
Mu lu ti c s Mu lu thanh tra
Mu lu ti b phn KN Mu lm KN
L thuc
Mu ring
Mu chung
Mu trung bnh th nghim
Mu gi (ly) KN
S

LY
MU
2/23/2014
14
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Ly mu c th:
Ly mu thuc c phn liu:
- Ly ngu nhin /v bao gi t l s/p to mu ban
u:
n: s bao gi ly ra
N: s /v bao gi cui cng trong l
+ Phn thp phn < 0,5 b qua; t 0,5 tr ln thm 1 /v
+ N > 100 th n
max
30
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Ly mu c th:
+ N 100 tra bng
N n
1 - 10 1
11 - 40 2
41 - 80 3
81 - 100 4
Kim nghim thuc theo tiu chun
Ly mu sn phm l cht rn (ht, bt, vin):
Trng hp mt bao gi
- Xem xt ng nht ca sn phm, nu khng
ng nht phi phn loi, ly mu ring theo tng
loi
- Mu l ht, cc cn nghin nh thnh bt (tr khi
cn x/ c ht)
- Ly mu ban u 3 v tr: trn, gia, di, trn li
thnh mu chung
Kim nghim thuc theo tiu chun
Ly mu sn phm l cht rn (ht, bt, vin):
Trng hp mt bao gi
- Chia nh u mu chung thnh mu TBTN (2 - 4 ln
lng mu th cn ly)
B
B
- Chia mu TBTN thnh mu lu v mu KN
Trng hp nhiu bao gi
Kim nghim thuc theo tiu chun
Ly mu sn phm lng
Trng hp mt bao gi
- S/p ng nht: ly mu bt k v tr no
Trng hp nhiu bao gi
- S/p cha ng nht: phi khuy u trc khi ly
mu
- Nu l chai, l nh c th ly ht th tch
Kim nghim thuc theo tiu chun
Ly mu sn phm thuc m, bt nho
- Cn khuy k, trn u cho s/p ng nht trc khi
ly mu
- Ly mu nh vi mu lng, rn
Ly mu thnh phm cha ng gi l
- L s/p c 1 2 bao gi: m c 1 hoc 2 bao gi
- L s/p c 3 bao gi: m 3 bao gi
- Ly t nht 3 mu ban u 3 v tr khc nhau ti
mi bao gi
- Trn u to mu TBTN
2/23/2014
15
Kim nghim thuc theo tiu chun
Ly mu kim nghim
Bao gi v dn nhn:
- Sau khi ly mu cho vo ng, ngi ly mu
bao gi, dn nhn, nim phong mu
- Phi c ch k xc nhn ca c s c ly mu
trn nim phong v bin bn ly mu
Kim nghim thuc theo tiu chun
Tin hnh kim nghim
Nhn mu:
- Mu phi c ly ng theo TT quy nh
- Mu phi c ng gi, nim phong, c nhn
thng tin cn thit (tn thuc, s l, TCYC kim tra)
- Cc mu do thanh tra ly v phi c bin bn ly mu
- Cc mu gi phi km cng vn, giy gii thiu
- Mu xin php SX phi km TL theo quy nh
- Mu nhn qua ng bu in: kim tra k nim
phong, bo li ni gi, ch KN sau khi c kin ca
ni gi mu
Kim nghim thuc theo tiu chun
Tin hnh kim nghim
Kim nghim, x l kt qu:
- Chun b TL: TCVN, TCCS
- Chun b dng c, ha cht, thit b theo y/c TC
quy nh. B tr TN hp l mu lm, trnh
nhim bn, bin cht mu
- Tin hnh phn tch theo TC
- X l s liu, a ra kt lun v mu (t, khng t)
- Ngi lm KN cn c s ghi chp y s liu khi
tin hnh TN, s ny l bn gc ca s liu cng b
trn phiu KN
Kim nghim thuc theo tiu chun
Tin hnh kim nghim
Vit phiu tr li kt qu
- Tr li bng phiu KN hoc phiu phn tch
- Phiu KN: xc nhn KQKN theo TLKT hp php ca
mt mu thuc
- Phiu phn tch: xc nhn KQPT ca 1 hay nhiu
tiu ch trong TCKT ca 1 mu thuc
KNV vit phiu tr li ni b
(cha chnh thc) , k tn
CB ph trch phng TN duyt li,
a phng chc nng
Lnh o duyt ln cui
Tr li chnh thc bng phiu
KN hay phiu phn tch
Kim nghim thuc theo tiu chun
Tin hnh kim nghim
Ni dung chnh phiu KN
- Tiu : tn CQKN, s phiu KN, tn mu KN, l lch
mu..)
- Cc ch tiu th
- Kt lun cui cng v mu c KN
- Ch vit trong phiu KN phi r rng, chnh xc, y
v thng nht
2/23/2014
16
Kim nghim thuc theo tiu chun
Tin hnh kim nghim
Lu mu ti CQKN
- Mu lu phi c nh s cng SK mu th
cng loi
- c s dng trong TH c tranh chp v KQ
cng b phiu KN
- Phi c lu ng thi gian quy nh (3 thng sau
khi ht HD vi mu c HD)
- S, phiu KN phi lu t nht 3 nm, hy phi c
GCQ duyt
Ni dung chnh ca GLP
Mc ch
- Xy dng /v KN p ng y y/c cng tc KTCL
thuc
- m bo KQPT thu c tin cy, c tnh php l
- Gip tra cu, tm ra nhanh chng ngun gc sai st
Ni dung chnh ca GLP
V t chc v nhn s
- Phng KN thuc phi c cc b/p chuyn mn,
hu cn, ng k, lu tr mu c chc nng nhim
v r rng, c XD, c ngi c thm quyn ban
hnh
- Nhn vin phi c o to, HL v chuyn mn
c th thc hin n/v c giao, c tinh thn trch
nhim cao
- Nhn vin phi mc trang phc theo quy nh, phi
c k/tr sc khe, khng lm nhim bn cc php
th, dng c, h thng TN
Ni dung chnh ca GLP
V c s vt cht chung
- C din tch lm vic ph hp vi y/c t ra, cho
php sp xp hp l dng c, thit b; c mi trng
tt v nh sng, thng gi, t
o
, m..
- m bo tnh bit lp: khng b nhim bn do mi
trng hay b/p ln cn, m bo v sinh theo quy
nh
- Bo m cng tc an ton, cc phng tin bo h
L, s dng, bo qun cht c, x l cht thi
Ni dung chnh ca GLP
Trang thit b
- c trang b y TTB p ng y/c th
nghim. Thit b cn c la chn, chun ha, c CL
ph hp.
- TB phi t v tr thch hp, tin cho s dng, kim
tra, bo dng
- nh k phi c hiu chun, kim nh, bo dng
- Phi c ni quy vn hnh, HDSD, s theo di SD, c
nhn chu trch nhim qun l
Ni dung chnh ca GLP
C s vt cht cho cc php th
- Tt c php th phi c quy trnh c vit chi tit v
chun ha
- Mi ha cht, TT, cht chun phi p ng ng cc
y/c quy nh
- TT, ha cht, cht chun b bin cht, qu hn
khng c php s dng
Quy nh v nguyn tc
- C s cho cc php th t, /lng, tinh khit, hot
lc, bn vng ca thuc, quy nh v mu th,TT,
cht i chiu
2/23/2014
17
Ni dung chnh ca GLP
Quy nh v quy trnh v hng dn th nghim
- Quy trnh, hng dn th nghim phi r rng, chnh
xc, c chun ha, c lnh o duyt thng qua
- KNV tin hnh TN phi bo co chi tit nhng hin
tng gp phi trong qu trnh TN vi ph trch
Quy trnh v bo co kt qu
- Phi bo co y : mc ch TN, ni TN, tn mu
th, ngy TN, pp s/d, ngi TN, pp x l s liu, KQTN,
kt lun, k xc nhn, ni lu mu lu, HS, TL
KN THUC BNG CC PP HA HC
Phng php chun acid base trong mi
trng khan
nh tnh mt s ion bng p/ ha hc
Xc nh gii hn tp cht
Cc phn ng nh tnh
T c SGK Mc ch: th tinh khit ca thuc
Tc hi ca tp cht:
- Gy hi cho sc khe
- Gy tng k ha hc: nh hng ti phm
cht, bn ca thuc
- Xc tc y nhanh qu trnh phn hy thuc (vt
kim loi, m)
- Th hin mc tinh khit cha m bo
ngha:
- Cho bit mc tinh khit ca thuc
- Cho php xem xt ngun gc gy ra tp khc
phc
Th gii hn tp cht trong thuc
Nguyn nhn gy ra tp cht:
- NL, ph liu, bn thnh phm cha tinh khit
- Quy trnh SX cha ph hp hoc cha c
thc hin nghim chnh
- Dng c s dng cha ph hp
- Phng php SX cha tt
- Pht sinh trong qu trnh bo qun do mi
trng, v sinh, cht bo qun
- Dng gian ln ca nh SX
Th gii hn tp cht trong thuc
Phng php xc nh:
-Xc nh xem cc tp cht c vt g/h cho php
khng
-Dng cc p/ bn nh lng
-Thc hin bng pp so snh
Phng php x/ g/h tp cht
2/23/2014
18
Mu th
Mu chun so
snh
(c cha tp
cn th vi s
lng g/h
cho php)
1 2
1
2
1
2
So snh c
So snh mu
Quy nh:
-Ha cht, dung mi khng c c tp cn th
-S dng cn phn tch, dng c th tch chnh
xc khi chun b mu th v mu chun so snh
-Hai ng phn ng so snh phi ging nhau
hon ton
-Thuc th cho vo hai bnh phi ging nhau v
thi gian, s lng, th tch
-So mu: nhn ngang trn nn trng
-So c: nhn t trn xung
Phng php x/ g/h tp cht
C acid - base trong mi trng khan
C s l thuyt:
Thuyt proton ca Bronsted Lowry
- Cp acid base lin hp
HA H
+
+ A
-
- P/ acid base:
Acid 1 + Base 2 Acid 2 + Base 1
C acid - base trong mi trng khan
Vai tr ca dung mi:
C th tc ng theo 2 hng
Solvat ha cht tan Solvat ha cht tan
-Dung mi c tnh acid: lm tng tnh base ca cht tan
R-NH
2
+ CH
3
COOH R-NH
3
+
+ CH
3
COO
-
-Dung mi c tnh base: lm tng tnh acid ca cht tan
HA + S A
-
+ SH
+
-Dung mi tr: solvat ha theo c ch khc (lin kt hydro,
phc , lc Van der Waals)
C acid - base trong mi trng khan
Tc ng ln qu trnh in ly ca cp ion Tc ng ln qu trnh in ly ca cp ion
-Dung mi c ln: ion to ra do solvat ha u phn ly
thnh ion t do
-Dung mi c nh: ion tn ti di dng cp ion
Qu trnh in ly ca cp ion do quyt nh
HA + S HS+A- HS+ + A-
K
i
K
d
Solvat ha in ly
C acid - base trong mi trng khan
Phn loi s b dung mi theo Phn loi s b dung mi theo
- > 50: H
2
O, formamid, dimethylsulfoxid: acid, base tn ti
ch yu di dng ion t do
- < 30: ethanol, aceton: tn ti nhiu cp ion
- < 10: benzen, cloroform, acid acetic: tn ti cp ion l ch
yu
2/23/2014
19
C acid - base trong mi trng khan
Khi nim pH:
-Trong dung mi khan, x/ pH biu kin
HS + HS H
2
S
+
+ S
-
H
2
S
+
l ion lionium, S
-
l anionlyat
pH biu kin: pH =
K
s
=
-Thang c lin quan ti hng s t in ly K
s
ca dung mi
C acid - base trong mi trng khan
Khi nim pH:
VD: 2CH
3
COOH CH
3
COOH
2
+
+ CH
3
COO
-
K
s
= [CH
3
COOH
2
+
][CH
3
COO
-
]
- di thang pH biu kin ph thuc vo K
s
:
Methanol: pK
s
= 17
Ethanol: pK
s
= 20
Acid acetic: pK
s
= 6,35
C acid - base trong mi trng khan
Xc nh im tng ng:
Ch th mu pH - Theo di s i mu ca CT
Ch th o th
- in cc SS: calomel, bc clorid
- in cc CT: thy tinh
Ch
- Khi x/ im tng ng theo di s thay i in th
- Cn trung ha dung mi trc khi chun
- Cn x l in cc CT ph hp
- Hay s/d: tm tinh th, tm methyl, CT hh
C acid - base trong mi trng khan
ng dng trong KN thuc:
- Khi cht phn tch khng ha tan trong nc
-Tnh acid, base qu yu trong mi trng nc, khng x/
c im tng ng
- Cc acid, base a chc c hng s in ly trong nc t
khc bit nhau
C acid - base trong mi trng khan
nh lng acid:
Cc cht HC c tnh acid yu:
- Acid carboxylic
- Dn xut enol, imid, sulfonamid
- Dn xut th phenol: polyclorophenol, polynitrophenol
- Hh cc cht c tnh acid hay acid a chc
- Dng dung mi base tng tnh acid ca cht phn tch
- Dung mi hay s/d: pyridin, DMF, t-BuOH (C acid
carboxylic, d/x phenol)
i tng
Dung mi
C acid - base trong mi trng khan
nh lng acid:
Cc dd chun base:
- KOH trong MeOH
- Methylat kim loi kim (natri, kali)
- Tetraalkylammonium hydroxyd
(t-Bu
4
NOH/benzen MeOH (95:5))
- Dd chun KL kim d gy sai s base cho in cc TT
- Tetraalkylammonium hydroxyd: c, pha ch lu, kh
bo qun
Dung dch chun
Ch
2/23/2014
20
C acid - base trong mi trng khan
nh lng acid:
- Acid benzonic (C6H5COOH): E = M = 122,12
- Acid succinic (CH2COOH)2: E = M/2 = 59,05
- Acid sulfamic (NH2SO3H): E = M = 97,09
- Kalihydrophtalat, E = M = 204,22
Cht chun
C acid - base trong mi trng khan
nh lng base:
Cc alkaloid, base nit tng hp
i tng
Dung mi
- Dng dung mi acid tng tnh base ca cht phn tch
- Dung mi hay s/d: AcOH, anhydrid acetic (khng dng
/l amin bc 1,2), MeCN
C acid - base trong mi trng khan
nh lng base:
- HClO
4
trong AcOH khan
- HClO
4
trong 1,4-dioxan
Dung dch chun
- Kalihydrophtalat, E = M = 204,22
Cht chun
Phn ng chun
- Solvat ha: RNH
2
+ CH
3
COOH RNH
3
+
CH
3
COO
-
- Trung ha:
RNH
3
+
CH
3
COO
-
+ HClO
4
RN
+
H
3
Cl
-
O4 + CH
3
COOH
C acid - base trong mi trng khan
nh lng mui:
Mui ca cc acid yu hn AcOH BH
+
Y
-
- Y
-
: propionat, maleat, benzoat, salicylat
- BH
+
Y
-
c C trc tip nh 1 base bng HClO
4
- Y- c trung ha bng HClO
4
, p/ khng c hiu
Mui ca cc acid mnh hn AcOH BH
+
X
-
- X
-
: halogenid, sulfat
- Halogenid: X
-
qu yu, khng p/ ton lng c
vi HClO
4
Pp Pifer - Wollish
2BH
+
X
-
+ Hg(CH
3
COO)
2
2CH
3
COO
-
BH
+
+ HgX
2
2CH
3
COO
-
BH
+
+ 2HClO
4
2CH
3
COOH + 2BH
+
ClO
4
-
Pp Billon
- Ha tan mui trong ethanol, BH+ l acid mnh c th C
bng NaOH 0,1N
-Thm HCl d chuyn ht B (nu c trong BH+X-) thnh
BH+
B + HCl BH
+
+ Cl
-
HCl + NaOH NaCl + H
2
O
BH
+
X
-
+ NaOH NaX + B + H
2
O

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