Part VII: Holding Dietary Supplements

Introduction
Retaining dietary supplements with proper and suitable care is another major component of adhering to cGMP regulations. Guidelines for holding and distributing dietary supplements are designed to maintain the safety of dietary supplements safe while being held and distributed by the manufacturer. Dietary supplements must be held and transported in an appropriate manner in order to ensure proper retention and distribution. To ensure cGMP compliance, the FDA requires all those who manufacture, package, label or hold dietary supplements to follow these holding and distribution guidelines.

Guidelines for Holding and Distributing Dietary Supplements: Storage
All components and dietary supplements are required to be kept under proper temperature, humidity and light conditions

These conditions must be met in order to ensure the identity, purity, quality, composition and strength of the dietary supplement

Packaging and labels for dietary supplements must be kept in appropriate conditions to prevent errors, contamination or deterioration

All in-process materials must also be kept in appropriate conditions to prevent errors, contamination or deterioration

Guidelines for Holding and Distributing Dietary Supplements: Reserve Samples
A reserve sample of a dietary supplement must be held in proper condition to prevent against contamination and decomposition

The sample must be held in the conditions as described on the dietary supplement’s label

This sample must use the same container-closure system to be kept as with the dietary supplement to prevent contamination and deterioration

Reserve samples must be retained for at least 1 year past the dietary supplement’s shelf life or for 2 years from the last date of distribution

Guidelines for Holding and Distributing Dietary Supplements: Distribution
Distribution of dietary supplements must be done under proper conditions in order to prevent contamination and deterioration

Guidelines for Holding and Distributing Dietary Supplements: Record keeping and Procedures
Records of holding and distributing of dietary supplements must be kept in order to prevent errors and contamination

It is required to have established written procedures that must be followed for holding and distribution of dietary supplements