1. thuc tap huong dan ghi nhan thuoc

7/26/2019 1. Thuc Tap Huong Dan Ghi Nhan Thuoc

1/17

1/20/20

MT S QUY NH LIN QUAN N

VIC GHI NHN THUC

DS. NGUYN TH QUNH NGAKhoa Dc - H Y Dc TP.HCM

1

THC TP PHP CH DC

Bui 6

GHI NHN THUC

C bao nhiu ni dung ca nhn thnh phm

thuc thng thng?


2/17

1/20/20

NI DUNG CA NHN THUC

Nhn thng thng

ND bt buc

ND khng bt buc

3

GHI NHN THUC

K tn cc ni dung bt buc trn nhn thnh phm

thuc thng thng?


3/17

1/20/20

NI DUNG CA NHN THUC THNG THNG

1. Tn thuc

2. Hot cht, hm lng hoc nng

3. Quy cch ng gi

4. Ch nh, cch dng, chng ch nh

5. Dng bo ch, SK, hoc SGPNK, LSX, NSX, HD, KBQ

6. Cc du hiu lu

7. Tn v a ch ca t chc, c nhn chu trch nhim

8. Xut x ca thuc

9. Hng dn s dng thuc5

GHI NHN THUC

C my loi nhn c bit?


4/17

1/20/20

NI DUNG CA NHN THUC

7

Nhn c bit

Nhn nguyn liu

Nhn trn v thuc

Nhn BB c kch thc nh

Nhn pha ch theo n

Nhn phc v mc tiu QG

NI DUNG CA NHN C BIT

NHN NGUYN LIU

- Tn nguyn liu

- Hm lng hoc nng (nu c)

- Tiu chun ca nguyn liu

- Khi lng tnh hoc th tch

- S l sn xut, ngy sn xut

- Hn dng, iu kin bo qun- S ng k (nu c)

- Tn, a ch c s sn xut, xut x ca thuc

Tn, a ch c s nhp khu (i vi nguyn liu nhp khu)

1

8


5/17

1/20/20

NI DUNG CA NHN NGUYN LIU

CNG TY HA DC 5a ch: 1 Nguyn Vn A, TX. B, Tnh C

AMPICILLIN (DVN IV)99% C16H19N3O4S

1 kg

L SX :Ngy SX : KBQ :HD : SK :

9

11

GHI NHN THUC

Nu l nguyn liu thuc Gy nghin, hng tm thn v

tin cht dng lm thuc,

th nhn nguyn liu c g c bit?


6/17

1/20/20


Gy nghin phi c ch GY NGHIN

Hng tm thn phi c ch HNG TM THN

Tin cht phi c ch TIN CHT DNG LM THUC

Cc ch GY NGHIN, HNG THN, TIN CHT DNG LM

THUC c in m trong khung trn ti gc trn bn phi ca nhn

thuc.

11


CNG TY HA DCa ch: .......................

MORPHIN CLOHYDRAT (DVN IV)98% C17H19O3, N. HCl

1 kg


GYNGHIN

12


7/17

1/20/20


CNG TY HA DCa ch: .......................

EPHEDRIN CLOHYDRAT (DVN IV)98% C10H15ON. HCl

1 kg


HNG

TM THN

13

GHI NHN THUC

Nhn trn v thuc c nhng ni dung no?


8/17

1/20/20


NHN TRN V THUC

- Tn thuc

- Hot cht, hm lng

Thuc dng phi hp 3 hot cht: ghi hot cht, hm

lng ca tng hot cht

- S l sn xut, hn dng

- Tn CSSX (vit tt bo m nhn din c tn CSSX)

2

15


2

16


9/17

1/20/20


2

17


2

18


10/17

1/20/20


19

GHI NHN THUC

Nhn chai l thuc tim, ng tim, ng ung

c nhng im ging nhau v khc nhau nh th no?


11/17

1/20/20


NHN TRN BAO B TRC TIP C KCH THC NH

Nhn chai l thuc tim, ng tim, ng ung

Ging : - Tn c s sn xut

- Tn thuc, hot cht, hm lng

- Th tch, khi lng

- SK, s LSX, HD

Khc :ng tim ng ung

Ghi ng dng Ghi dng ch

tb, tdd, tm Khng c tim

3

21


NHN TRN BAO B TRC TIP C KCH THC NH

ng tim ng ung

Ghi ng dng Ghi dng ch

tb, tdd, tm Khng c tim

3

22


12/17

1/20/20

GHI NHN THUC

Nhn thuc pha ch theo n v

Nhn thuc phc v chng trnh mc tiu y t quc gia

C im g c bit?


NHN THUC PHA CH THEO N

- Tn thuc, dng bo ch

- Hot cht, nng hoc hm lng

- Ngy pha ch, hn dng

- ng dng

- Tn bnh nhn

- Tn ngi pha ch

- Tn, a ch c s pha ch thuc.

4

24


13/17

1/20/20


NHN THUC PHC V CHNG TRNH MC TIU Y T QG

C y ni dung bt buc theo qui nh + dng ch :

THUC CHNG TRNH KHNG C BN

5

25

GHI NHN THUC

Cch vit SK, GPNK, S l SX, NSX, HD, KBQ

nh th no?


14/17

1/20/20

NI DUNG CA NHN THNH PHM

Gm 6 mc

1/ S ng k ( SK : xx xxxx xx )

2/ S giy php nhp khu : ( GPNK : xxxx/QLD xx )

3/ S l sn xut (L SX : xxxx), do c s Q

4/ Ngy sn xut ( NSX : xx xx xx, hoc xx xx xxxx)

5/ Hn dng (HD)

Nu nhn ghi NSX v HD bng ting nc ngai th phi ghi

thm trn nhn ph l : NSX, HD xem Mfg Date Exp Date

6/ iu kin bo qun (KBQ)

27


CC DU HIU CN LU

- Thuc k n phi ghi k hiu Rx gc bn tri ca tn thuc v dng

ch THUC BN THEO N

- Thuc tim phi ghi r ng dng ca thuc (tb, tdd, tm)

- Thuc nh mt, thuc tra mt ghi dng ch THUC TRA MT

- Thuc nh mi ghi dng ch THUC NH MI

- Thuc dng ngoi da ghi dng ch THUC DNG NGOI- Thuc ng ng ung ghi dng ch KHNG C TIM

- Trn nhn thuc phi ghi dng ch XA TM TAY TR EM, C

K HNG DN S DNG TRC KHI DNG

28


15/17

1/20/20


CNG TY C PHN DC TW MEDIPHARCO-TENAMYD8 Nguyn Trng T, Tp.Hu, Vit Nam

MULTIVITAMIN10 V x 10 vin, vin nn di bao phim

Cng thc : L SX :Cng dng : Ngy SX :Cch dng : HD :

KBQ : SK :

29


30


16/17

1/20/20


CNG TY C PHN DC PHM OPC1017 Hng Bng, Phng 12, Qun 6, TP.HCM

Rx QADevirHp 3 v x 10 vin nn

Cng thc: L SX :Cng dng: Ngy SX :Cch dng: HD :

KBQ: SK :

THUC BN THEO N31


CNG TY C PHN DC PHM 3-210 Cng trng Quc t, Qun 1, TP.HCM

THUC TRA MT

NaCl 0,9%L 10ml

Cng thc: L SX:Cng dng: Ngy SX:Cch dng: HD:

KBQ: SK:

32


17/17

1/20/20


X NGHIP DC PHM TRUNG NG 25120 Hai B Trng, Qun 1, TP.HCM

THUC NH MI

RHINEX 0.05%Chai 15ml

Cng thc : L SX :

Cng dng : Ngy SX :Cch dng : HD :KBQ : SK :

33

XIN CHN THNH CM N

S THEO DI CA CC BN

34

1. thuc tap huong dan ghi nhan thuoc

Documents