Guys

I am looking for material or refrence in order to perform executed batch record review What should I need to focus? or what point I need to note? I would appreciated if you guys share any material or knowledge


Thanks in advance

Can anyone help with this OPs question?

How about the requirements related to the "batch"?

Were they met?

Does the "batch" meet whatever the requirments state it is supposed to meet?

Guys

I am looking for material or refrence in order to perform executed batch record review What should I need to focus? or what point I need to note? I would appreciated if you guys share any material or knowledge


Thanks in advance

In a previous life when this was part of my job responsibility, I would review the contents of the batch/lot file and compare it to the requirements in 21 CFR 820 to make sure that everything necessary was present. If something was missing, I would go to the person or department responsible for providing that piece and find out why it wasn't in the file. After I had reviewed everything and felt confident that the file was complete, I would prepare a short statement declaring the file complete, or as complete as possible, and close the file and then release the goods (if necessary) for the next phase of production or shipment, whichever was appropriate.

Added: Please note that my previous company was not registered to any ISO standard.

Depending on the product and your company's processes, you may have additional steps or perhaps fewer steps involved. It just depends on your company's needs.

I hope this helps. :bigwave: