FAQ Friday: Batch Production Records

Batch Production Records (BPR) document the when, how, by whom with what tools and what environment a product
was produced. The FDA required Batch Production Records for every batch
created in a manufacturing facility. InstantGMP software allows you track batches electronically and we are asked many questions about BPR:

Can I sign for someone else on a Batch Record?
The login credentials are to be kept safe and not shared. This
electronic signature is a legal signature and binding; you only want to
sign for things that you actually performed. This is part of 21 CFR Part 11 compliance. Signing for someone else in
the batch record goes against FDA regulations as it interferes with
traceability.

Where can I enter my own batch record number? We do not want to use the InstantGMP automated number system.
There is a field on the Batch Cover page for “Production Number” that will populate tables for traceability.

Why can’t I make a batch record from the master record?
Make
sure all the required approval signatures for that master record have
been confirmed, and try again. The master record should now be a
drop-down choice.

Can we revoke signature responsibilities for MPRs and BPRs?
Navigate to the project personnel page, select the update arrow for the
project in question and de-select the MPR and/or BPR signature checkbox.

For more information about BPRs, MPRs, and GMP, please check out our resources.

 

the
when, how, by whom, with what tools and in what environment a product
was produced. – See more at:
http://www.instantgmp.com/_blog/InstantGMP_Blog/post/mbr-and-bpr-defined/#sthash.m5NxrVhM.dpuf
the
when, how, by whom, with what tools and in what environment a product
was produced. – See more at:
http://www.instantgmp.com/_blog/InstantGMP_Blog/post/mbr-and-bpr-defined/#sthash.m5NxrVhM.dpuf
the
when, how, by whom, with what tools and in what environment a product
was produced. – See more at:
http://www.instantgmp.com/_blog/InstantGMP_Blog/post/mbr-and-bpr-defined/#sthash.m5NxrVhM.dpuf

 

 

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