According to the FDA, a batch, or lot, means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and are intended to have uniform characteristics and quality within specified limits.

Batches of products typically go through the manufacturing process at the same time. If an error or problem developed in the manufacturing process, products in the same batch should either all be affected by the error or none of them affected by the error. When a product non-conformance is detected, quality managers should look at other products in the same batch to determine whether they too are affected.

The definition of a batch has nothing to do with how many units there are. A batch could include just one unit or hundreds. Medical device companies can determine how best to group products into batches for record-keeping.

What are electronic batch record?

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Medical device companies should be aware that the FDA regulations in 21 CFR Part 820 make no explicit references to "batch records", but that they absolutely are required. The FDA requires medical device companies to maintain a device history record (DHR) for each medical device they produce, which is essentially the same thing as a batch record.

Manufacturers must maintain device history records for every batch, lot, or unit of product that they produce, and the records should demonstrate that the device is manufactured in accordance with the device master record (DMR) and the overall requirements of the FDA QSR.