Regulatory Open Forum

Hello Forum,

We are an NHP manufacturer in the US.  Our Canadian NHP Importer is requiring "batch records" for every lot.  These are ~20 pages of completed work orders.  We have already supplier Master Production Documents.  The regulation, related to batches, is that the Importer maintains "records of any testing conducted in respect of a lot or batch of the NHP".  We are submitting CofAs with all test results.  NHP GMP guidance requires the Importer have "access" to batch records (Importer needs to make sure that records are available in timely manner).  We have already submitted batch records that show they are complete and available.  The guidance also states that a certificate of manufacture (defined in the guidance - basically a CofC) is an acceptable alternative to lot or batch documents.

My interpretation is that CofAs (with all test results) are the only requirement per batch and that a CofM can be used instead.  I see no requirement for them to have full, completed work orders.

Can anyone clarify this, please?  If you have expertise in this area, I would like to contract that expertise to help resolve this issue.

My interpretation would be the same as yours. (Not an expert in that area, though.)

When we have had differences in interpretation with our business partners, usually a discussion has led to some kind of agreement, but not always. Sometimes the resolution remains imperfect...

With one company, their policy said we had to provide some silly information while our policy was that we wouldn't, and we decided we didn't care to do business with them. With another, where the revenue was more important to us, we agreed to waste time doing the inappropriate information transfers. With a third, they settled on sending monthly automated emails informing us that we were out of compliance, which we simply deleted.