GMP Testing of Herbals and Botanicals

In order to provide high quality herbal and botanical dietary supplements, testing and controls are necessary as described in the FDA's Final Rule on GMP Dietary Supplements. Botanicals are often complex mixtures that can vary in composition depending on factors such as the part of the plant used, the location of harvesting and growing conditions that can vary from year to year even in the same location. It can be important to distinguish between closely related species of botanicals, since the biological activity  of an incorrectly identified species can lead to adverse consequences. Also, different species may show up in different ratios in a particular product.  There are situations where various products might contain different parts of the plant--flower, leaf, root, stem, extract--and the test methods for each can vary in the nature, sensitivity, and specificity of the test.  These challenges make it essential that appropriate tests and methods are developed and used for controlling the dietary ingredients that are included in the final product.

Each manufacturer must perform 100% identity testing to verify the identity of each dietary ingredient and each component used in the final product prior to manufacturing. In addition, each dietary ingredient has to be tested for potency and purity. The requirement of 100 percent identity testing can be reduced if a manufacturer petitions the FDA for an exemption and the agency grants the exemption. The procedure can be found in this FDA guidance.

PharmaDirections has Chemistry and Manufacturing Control (CMC) experts available to help design methods and specifications for herbal, botanical and other dietary supplement products.

Dietary Supplements Resource Pages:

• What are Dietary Supplements?
• What is GMP?
• What is GMP for Dietary Supplements?
• Highlights of Final Rule for GMP Dietary Supplements
• Manufacturing Process Controls for Dietary Supplements
• Specifications for Dietary Supplements
• Master Manufacturing Records for Dietary Supplements
• Labeling of Dietary Supplements
• Testing Herbals and Botanicals
• Quality and Control of Dietary Supplements
• GMP for Dietary Supplements - Consulting Services