AHPA releases guidance on liquid extract specs for cGMP compliance
September 27, 2022
AHPA has released a new guidance document titled, “Guidance for Liquid Extract Specifications for cGMP Compliance.” Developed to support liquid extract manufacturers in documenting compliance with current good manufacturing practices (cGMPs) and labeling requirements for dietary supplement products, the guidance document is now available for AHPA members to view and download on the AHPA website.
Current U.S. regulatory requirements for establishing dietary supplement product specifications and certain labeling requirements can be challenging to apply to liquid extract products. AHPA's guidance provides a point of reference when corresponding with U.S. Food & Drug Administration (FDA) staff about how to apply cGMPs to specific liquid extract product types by incorporating key regulatory citations and providing suggested narrative justifications.
In addition, the guidance provides a menu of options with illustrative examples of different approaches to presenting liquid extract product information in various contexts, including Supplement Facts boxes, master formulas, and product specifications. The examples include narrative content that explains the alignment of the elements and their relationship to the product specifications. The examples provided are intended to function as customizable templates which are also available for download and use as separate documents.
Guidance is provided for the following extract categories:
Ratio liquid extracts
Marker liquid extracts
Liquid extracts with no ratio and no marker
Concentrated liquid extracts
Liquid extract blends
Liquid group extractions
AHPA produces guidance documents to help the dietary supplement and herbal products industries comply with applicable laws and regulations and institute best practices for ensuring quality and transparency. This guidance was developed by a working group of AHPA members who produce liquid extracts and other interested parties. Particular acknowledgement and thanks are due to Staci Eisner of Cortex Scientific Botanicals, who served as the primary editor of the document.