ISPE GEP document published - FDA.COMs Community Forums

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Post: ISPE GEP document published

JohanJ
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Posts: 229
JohanJ

Age: 37
Loc: Belgium
Registered on 12-11-07

01-27-09 10:20 PM - Post#5498
In response to IHN1

Dear IHN

A part from ISPE not having any statutory force it is well (very well) known that they tend to work very close with regulatory bodies such as FDA. In fact they try to have their stuff reviewed by FDA before spreading it.

Furthermore. All the people working on the ISPE guidances are related to pharma companies are companies that need to abide by any regulatory body. So the initiative is very noble as you will have a pool of different views and interpretations on the same 'laws'. This variety in views opens quite some constructive discussions and if I am not mistaken form a basis of feedback to FDA.

So taken the above in account, you can almost blindly trust ISPE guidances to ensure compliance in your company.

Johan Janssens
Mobile: +32 498 68 29 56
e-mail: johan.janssens@qualiphar.com

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