RMSC QC WINGADVISOR DESK

09.08.2012

RMSC nokbZ;ksa dh xq.koÙkk fu;a=.k dSls djrh gS ?

2

1- tks Lo;a nok fuekZrk dEiuh gksA

2- ftldk foxr rhu o"kksZ dk vkSlru VuZ vksoj izfr

o"kZ 20 djksM :Ik;ksa ls de dk uk gksA

3- ftls nok fuekZ.k dk U;wure 3 o"kksZ dk vuqHko

(MSC) gksA

4- ftlds ikl xqM eSU;wQSDpfjax izSfDVl (GMP)

dk ;ksX;rk izek.k i= gksA 3

izfrf"Br] ;ksX; ,oa vuqHkoh nok fuekZrk dEiuh dk p;u

5- ftldh dksbZ nok Liwfj;l ;k ,MYVªsVsM ?kksf"kr ugha gqbZ

gks A

6- ftldh lIykbZ gsrq Quote dh tkus okyh nok foxr nks o"kksZ

ls voekud dksfV dh ?kksf"kr ugha gqbZ gks A

7- tks dsUnz ljdkj] jkT; ljdkj vFkok mudh

izksD;ksjesUV ,tsfUl;ksa }kjk Black-Listed vFkok Debar uk

dh xbZ gksA

8- tks ltk;k¶rk uk gksA (Non-Conviction Certificate ) 4

izfrf"Br] ;ksX; ,oa vuqHkoh nok fuekZrk dEiuh dk p;u

1- RMSC }kjk nok dk ijpst vkMZj nsus ckn gh fuekZ.k dk;Z

'kq:A‘

2- nok ds lkFk fuekZrk dh cSp QC Passed Test Report nsuk

vfuok;Z

3- nok dh 'ksYQ ykbZQ 'ksM~;wy&ih ds vuqlkj rFkk vU;

nokvksa ds ekeys esa U;wure 2 o"kZ rFkk Retained 'ksYQ

ykbZQ rhu&pkSFkkbZ ls de uk gksA

4- de rki ij j[kh tkus ;ksX; nok Cold Chain ds rgr lIykbZ gksaA

5

nok dh lIykbZ Lohdkj djus dk vk/kkj

5- nok ij mldk tsusfjd uke gh gksA

6- nok ds ysfcy ij fu/kkZfjr Logo “Rajasthan Govt. Supply-

Not for sale fu%’kqYd forj.k gsrq] QC – Passed”

eqfnzr gksA

7- nok ds ysfcy ij fu/kkZfjr Logogram eqfnzr gksA

8- nok ijpst vkMZj ds vuqlkj gks eky ds lkFk esa

fcy@buokbZl Hkha gksA

6

nok dh lIykbZ Lohdkj djus dk vk/kkj

7

Drug receipt at DDW Drugs quarantined at DDW

Sampling Samples Sent To RMSC Hqtrs

nok dh xq.koÙkk dk iqu% lqfu’prhdj.k djuk xq.koÙ

kk dks iqu%

lqfuf’pr djuk

le;≤ ij iqu% tkap

f'kdk;rh

ekeyksa esa tkap

8

nok dh xq.koÙkk dk iqu% lqfu’prhdj.k djuk

To empanelled Lab

xq.koÙkk dks iqu%

lqfuf’pr djuk

le;≤ ij iqu% tkap

f'kdk;rh

ekeyksa esa tkap

Quality Parameters

As prescribed under Second schedule of Drugs &

Cosmetics Act, 1940 :-

QkekZdksfi;y ekudksa ds vuq:i1. Identity 2. Purity3. Strength4. Bio-Availability etc.

9

Testing in Empanelled Lab

10

HPLC GC

AAS and ICP

DissolutionUV and KF IR

Test Reports

11

RMSC-QC Pass gksus ds ckn gh fjyht

12

De-coding of test reports

QC Passed QC FailedQC Failed

Batch release

instructions to DDW

RejectedRejected

Drugs distribution

starts

Batch returned

Batch returned

Computerized QC activities through

e-Ausahdhi Software.

RMSC-QC Fail gksus ij Reject & Returned

13

De-coding of test reports

QC Passed QC Passed QC FailedQC Failed

Batch release

instructions to DDW

Batch release

instructions to DDW

RejectedRejected

Drugs distribution

starts

Drugs distribution

starts

Batch returned

Batch returned

Computerized QC activities through

e-Ausahdhi Software.

Periodic QC Check

dqN nokbZ;ksa dh le;≤ ij iqu% tkap1- ftu nokbZ;ksa dh izFke VsfLVax esa

Assay value yksvj fyfeV esa gksA 2- ftu nokbZ;ksa ds voekud fudyus dh

lEHkkouk T;knk gksA3- ftuds dUVªksy lsEiy esa dqN HkkSfrd

ifjorZu tSls fyfDoM dk jax mM+ tkuk] ikVhZdy fn[kus yxuk bR;kfnA

14

lIy;kjksa

QeksZa dk p;u

xq.koÙkk dks iqu%

lqfuf’pr djuk

le;≤ ij iqu% tkap

Quality Check on Complaints

Further QC checks on receipt of specific complaint :

1. Foreign particles, fungus etc. ik;s tkus dh f’kdk;r izkIr gksukA

2. Unto wards reaction like rigors, rashes etc. dh f’kdk;r izkIr gksukA

3. Adverse Drug reaction dh f’kdk;r izkIr gksukA

4- nok vljghu gksus dh f’kdk;r izkIr gksukA

15

Generic Drugs Vs Branded Drugs

ewyr% izR;sd nok ij mldk tsusfjd uke gksrk gh gS

nksuksa dh Xkq.koÙkk ds ekud (Specifications of Standards) ,d tSls gksrs gSaA

nksuksa dh Xkq.koÙkk ds ekud ,d leku gksus ls Xkq.koÙkk ,d tSlh gksrh gSaA mudh DokfyVh esa dksbZ varj ugha gksrkA

16

Test Results of Generic Vs Branded Drugs at a Glance

17

1818

•Even with minimal Failure Rate

CONSUMPTION of such drugs

is

O%B’cause NOSQ Drugs are Discarded &

Returned and not Released

1919

RMSC dh nok mÙke xq.koÙkk dh gksus dh otg

•izfrf"Br] ;ksX; ,oa vuqHkoh p;fur nok fuekZrk dEifu;ksa ls gh [kjhnA•ijpst vkMZj nsus ckn gh fuekZ.kA•lIyk;j QeksZa dh nok dks RMSC }kjk bEisuYM yscl~ ls iqu% ijh{k.k djkus o mlesa [kjh DokfyVh dh ik;s tkus ij gh eky Lohdkjus dh 'krZA

2020

RMSC Empanelled Labs ls

iqu% ijh{k.k esa [kjh DokfyVh dh ugha ik;s tkus ij ml nok dks forj.k ds fy, fjyht

gh ugha fd;k tkrkA

2121

“eq[;ea=h fu’kqYd nok ;kstuk ds rgr

mRd`"V xq.koÙkk dh

nokbZ;ka miyC/k djkuk gh jktLFkku esMhdy lfoZl dkjiksjs’ku

dk eq[; mís’; gSA

2222

Thank you