A Primer on AHPA’s Good Agricultural and Collection Practices and Good Manufacturing Practices (GACP-GMP) Guidance for Botanical Materials

A Primer on AHPA’s Good Agricultural and Collection Practices and Good Manufacturing Practices (GACP-GMP) Guidance for Botanical Materials

What is AHPA's GACP-GMP guidance and how can it help your business?

Published: Wednesday, May 23, 2018

   

 

Event Details

Recorded: May 22, 2018

Duration: 2 hours

Cost:
Members - $150
Non-Members - $350

Materials:
Webinar recording
Presenter slides
Presenter biographies

FDA guidance

Recorded May 22, 2018

Botanical agricultural, collection and manufacturing practices have wide-ranging impacts on product quality, native and regional communities and the environment. AHPA's Guidance on Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials (GACP-GMP) provides a template for small and large growers, harvesters, and processors to implement and document best practices. The guidance and accompanying assessment tools help the industry ensure that herbal raw materials used in consumer products are accurately identified, not adulterated with contaminants, and fully conform to all quality characteristics for which they are represented.

Attend this webinar for an overview of the AHPA GACP-GMP program by Staci Eisner. Edward Fletcher will present on the application of the guidance and assessment tools. Anthony Young will cover current legal issues from a botanical supplement GMP perspective, and Connie Kehler from Canada’s Herb, Spice and Specialty Agriculture Association will discuss Canada’s established GACP program and the value it brings to the industry.

The AHPA GACP-GMP guidance serves as a template that growers, harvesters, and processors can adapt to their unique businesses, and is designed for both small and large producers. By establishing standard operating procedures that follow the practices presented in the AHPA GACP-GMP guidance, firms at every level in the supply chain will better ensure the production of good quality herbal raw materials.

AHPA GACP-GMP sections

Definitions

U.S. laws and regulations establish specialized definitions for various words and phrases, which are key to proper understanding of the applicable legal and regulatory requirements. In addition, some terms are unique to the botanical industry.

Botanical Identity and Quality

All steps in the production of a botanical material must be performed properly to ensure the quality of the finished material, starting with proper botanical identification and quality specifications.

Cultivation

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

Wildcrafting Collection

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

General Farm Standards

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

Harvest of Cultivated and Wild Collected Plants

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

Post-Harvest Handling

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

Further Processing and Handling

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

Food Facility and Farm Mixed-Type Facility Requirements

These sections outline the minimum requirements for facilities, equipment, and personnel required under 21 CFR Part 117 for processors of conventional foods and dietary supplements.

Dietary Ingredient Suppliers

Manufacturers often expect their ingredient suppliers to go above and beyond the basic requirements set forth in 21 CFR Part 117, particularly with respect to raw material controls, process controls, recordkeeping, and general quality systems management.

Presenters

  • Staci Eisner, Vice President of Quality and Regulatory Affairs, Cortex Scientific Botanicals
  • Edward Fletcher, Director of Quality and Sustainability, Herbal Ingenuity
  • Connie Kehler, Executive Director, Canada’s Herb, Spice and Specialty Agriculture Association
  • Anthony Young, Esq., Partner, Kleinfeld, Kaplan and Becker, LLP / AHPA General Counsel
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