GHTF (Global Harmonization Task Force) release 2 final documents

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#2
GHTF (Global Harmonization Task Force) question - Process validation decision

Hi, All,


in GHTF, it show the process validation decision flow chart if the process need validation.

In step 1. Is process output verifiable ?
how to know if process is verifiable?

Step 2: Is verification sufficient and cost effective?
how to know sufficient and cost effective?

thanks
 
T

treesei

#3
Re: GHTF (Global Harmonization Task Force) question - Process validation decision

This FDA document has some explanation of "verifiable".

http://www.fda.gov/MedicalDevices/D...122439.htm#what_processes_should_be_validated

Some most commonly used examples:

Sterilization process, whose output is not verifiable, because to verify the effectiveness of sterilization, one must break the sterilization barrier.

Soldering process, because to verify the quality of soldering, one must break the solder.

Visual inspection of the surface of solder is insufficient for soldering verification.

Animal test as a verification method for each and every product lot is not cost effective.
 
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