From: Stan Hilliard
Date: 06 Oct 2001
Time: 00:17:31
This is difficult because making the right choice requires predicting the future product quality and the accuracy of the C of A.
I suspect that whatever option you choose, the FDA would look favorably upon a document that enumerated the many factors that could allow poor quality to get through. Then the scheme that you adopt can be related to those factors. This would show that you analyzed the possibilities and made a reasoned attempt.
Stan Hilliard