ABSTRACT
It is required by §111.255(a) to prepare a batch production record (BPR) each and every time a batch of a dietary supplement is made.
The definition of the term “batch” is a specific quantity of a dietary supplement that is uniform; is intended to meet specifications for identity, purity, strength, and composition; and is produced during a specified time period according to a single manufacturing record during the same cycle of manufacture. Similarly, a “lot” is defined as a batch, or a specific identified portion of a batch. So, in effect from a regulatory point of view, a batch and a lot are the same. However, in general usage, the term batch usually refers to formulated bulk product in one or a few large containers, whereas a lot usually refers to packages of the finished product in the final containers. It is prudent for each firm to adopt standard nomenclature for these terms so that everyone in the organization clearly understands what constitutes a batch and a lot.
