inter-batch variability? [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2010-08-04 17:09  – Posting: # 5716
Views: 10,257

(edited by ElMaestro on 2010-08-04 17:22)

Dear Dan,

interesting question; I am not sure I understand it all, but I am sure there's hope!
First of all, there is no law against variation of any kind.
Second, you do not write anything about but did you receive a deficiency question from module 3 regarding the product's release specifications? After all, this is where the inter-batch variability comes into the picture. If the assessor for module 3 did not comment, then there is no issue.
On the positive side, the assessor tried to use common sense rather than cookbook in his/her assessment. On the negative side, he/she got something wrong in the creative mental process. I strongly recommend you to play the game of regulatory chicken if this is an EU submission.

Feel free to PM me re. this.

I could be wrong, but...
Best regards,
ElMaestro

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