Good Agricultural, Collection and Manufacturing Practices for Botanical Materials

Good Agricultural, Collection and Manufacturing Practices for Botanical Materials: Guidance and Assessment Tools

Agricultural, collection and manufacturing practices have wide-ranging impacts on product quality, native and regional communities, and the environment. This GACP-GMP guidance and assessment tools serve as templates that growers, harvesters, and processors can adapt to their operations to help the industry ensure that herbal raw materials used in consumer products are accurately identified, not adulterated with contaminants that may present a public health risk, and fully conform to all quality characteristics for which they are represented.

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The guidance is not a list of required prescriptions but rather a menu of options. Users are encouraged to identify and implement only those sections of the document that are relevant to their operations. Please carefully review relevant provisions in light of your company's circumstances and needs and implement whichever recommendations are useful and practical for your situation.

This guidance document is intended to complement the empirical knowledge that has been passed down from preceding generations involved in the cultivation, wild collection, and processing of useful plants. The industry is encouraged to give due consideration to long-established practices in growing, harvesting and processing herbs.

GACP-GMP Assessment Tools

GACP-GMP Operations Categories

Learn which sections of the AHPA GACP-GMP document are applicable to which operations

The operational categories provide direction regarding the sections of the AHPA GACP-GMP document that are applicable to the described operational functions. Companies may have operations that encompass one or more of these categories and should utilize all sections of the document that may be applicable to their operations.

Section 2: Botanical Identity and Quality Assessment Tool

All steps in the production of a botanical material must be performed properly to ensure the quality of the finished material

This form is for use in conjunction with Section 2: Botanical Identity and Quality,

Section 3: Cultivation Assessment Tool

Many factors must be considered and controlled in the cultivation of botanicals

This form is for use in conjunction with Section 3: Cultivation.

Section 4: Wild Collection Assessment Tool

Consideration of relevant factors will help ensure wild collection operations yield properly identified botanicals materials of the desired quality in a sustainable manner

This form is for use in conjunction with Section 4: Wild Collection

Section 5: General Farm Standards Assessment Tool

Guidelines in this section are intended to apply to farms (including wild collectors) that are not subject to 21 CFR Part 112 and are less strict

This form is for use in conjunction with Section 5: General Farm Standards

Section 6: Harvest Assessment Tool

Harvest timing, weather conditions, handling of the harvested material, and other factors must be carefully considered

This form is for use in conjunction with Section 6: Harvest of Cultivated and Wild Collected Plant

Section 7: Post-Harvest Handling Assessment Tool

Post-harvest activities are critical to ensuring the botanical material meets appropriate quality specifications

This form is for use in conjunction with Section 7: Post-Harvest Handling

Section 8: Further Processing Assessment Tool

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

This form is for use in conjunction with Section 8: Further Processing and Handling

Section 9: Food Facility and Farm Mixed-Type Facility Assessment Tool

These sections outline the minimum requirements for facilities, equipment, and personnel required under Part 117 for processors of conventional foods and dietary supplements

This form is for use in conjunction with Section 9 Food Facility and Farm Mixed-Type Facility Requirements

Section 10: Dietary Ingredient Supplier Assessment Tool

Manufacturers often expect their ingredient suppliers to go above and beyond the basic requirements set forth in Part 117, particularly with respect to raw material controls, process controls, recordkeeping, and general quality systems management

This form is for use in conjunction with Section 10: Recommendations for Dietary Ingredient Processors. Supporting information for specific elements can be attached to this form.
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