In this second series of cGMPs Demystified, we will investigate how companies producing dietary supplements can remain compliant in their written procedures and record keeping. FDA rules are filled with stipulations and guidelines for protecting the end user against undisclosed or inaccurate product information. The purpose of these guidelines is to establish quality standards for the dietary supplement industry. The FDA’s final rule contains specific information about written procedures and records needed to operate properly.

In this third segment of cGMP Demystified, we will dissect specific guidelines pertaining to quality control procedures. This is a major issue in regards to cGMPs because these standards were established mostly due to quality concerns over these dietary supplements. Without it, it is difficult to gauge the purity and content of the dietary supplement. The FDA requires those who manufacture, package, label or hold dietary supplement have their quality control personnel follow these procedures.