Further Processing Assessment Tool
Tuesday, May 25, 2021
Section: GACP-GMP Individual Assessment Tools

After being cleaned and often dried, botanical material may be subject to additional processing such as size reduction or extraction

Published: Tuesday, May 25, 2021

This form is for use in conjunction with Section 8 Further Processing and Handling. Supporting information for specific elements can be attached to this form.

After being cleaned and often dried, the botanical material may be packed and held for distribution, or it may first be subject to additional processing such as size reduction or extraction. As with other activities, these steps should be optimized appropriately in order to prevent degradation or contamination.

Plant material can be traded in a number of forms, including whole, chopped, cut and sifted, teabag cut, shredded, and powder. Cutting or chopping of plant materials can occur either before or after dehydration, while milling to powder is normally performed after drying. Size reduction operations should be conducted with practices that ensure that the material’s quality and purity are maintained.

Plant material may be extracted using various solvents and extraction technologies.

Extracting a botanical material for food use (as opposed to a non-food use such as for biofuels, pharmaceuticals, clothing, household products, cosmetics, etc.) is considered a food processing operation by FDA. Facilities that perform food extraction are generally (subject to certain exemptions) required to register with FDA as a food processing facility and to comply with 21 CFR Part 117 and/or Part 111 as well as other relevant FDA regulations, if the extracted material will be distributed in the US. This applies even if the facility is located outside the US.

Download Further Handling Assessment Tools