PART XII: Requirements for Collecting Representative Samples

As a critical component of the dietary supplement manufacturing process, collecting representative samples is important to everyone involved from quality control to final production. Description sources, batch numbers, dates collected and unique identification numbers are some of the imperative details needed for a manufacturer’s standard procedure for collecting representative samples of dietary supplements.

Requirements for Collecting Representative Samples:

Collect representative samples of each unique lot of components, packaging, and labels that you use to determine whether the components, packaging, and labels meet specifications established in accordance with § 111.70 (b) and (d) (Requirement to Establish a Production and Process Control System).

Collect representative samples of in-process materials for each manufactured batch at points, steps, or stages in the manufacturing process as specified in the master manufacturing record, where control is necessary to ensure the identity, purity, strength, and composition of dietary supplements, to determine whether the materials meet specifications established under final § 111.70 (c) , and as applicable, final § 111.70 (a) (Requirement to Establish a Production and Process Control System).

Collect representative samples of a subset of finished batches of each dietary supplement you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution, to verify that the finished batch of dietary supplement meets product specifications established in accordance with final § 111.70 (e), and applicable, final § 111.70 (a) (Requirement to Establish a Production and Process Control System).

Collect representative samples of each unique shipment, and each unique lot within each unique shipment, of product you receive for packaging or labeling as a dietary supplement (and distribution rather than for return to the supplier) to determine whether the received product meets the specifications established under final § 111.70 (f) , and as applicable, final § 111.70 (a) (Requirement to Establish a Production and Process Control System).

Collect representative samples of each lot of packaged and labeled dietary supplements to determine whether the packaging and labeling of the packaged and labeled dietary supplements meet specifications established in accordance with final § 111.70 (g), and applicable, final § 111.70 (a) (Requirement to Establish a Production and Process Control System).