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WHO PQ 流程
2007-09-30 11:13

A.     Publish expression of interest(EOI)

B.      Receive EOIs from manufacturers

C.     Send guidelines for product dossier to manufacturers

D.     Receive product dossiers, samples and SMFs

E.      Screen dossiers

F.      Evaluate product dossiers, prepare assessment reports

G.     Inform manufacturer of outcome of assessment

H.     Plan and perform inspections

I.         Inform manufacturer of outcome of inspection

J.        Assess additional data and information for product dossier

K.     Assess corrective action plan, plan follow-up inspection where relevant

L.      Inform manufacturer of outcome and decision

M.    Prepare list of products and Manufacturers meeting WHO norms and standards.

N.     Put on the WEB

O.     Submit EOI(and product dossier if requested)

P.      Submit product dossier and samples to UNICEF, Copenhagen Submit site master file (SMF)to WHO, Geneva

Q.     Submit additional data and information where requested

R.     Submit corrective action plan where requested


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1
2007-10-05 12:59
P.S PQ?
 
2
2007-10-08 16:48
不是的,这个专业性比较强的。只是当时得来不易,所以公开一下
 
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