cGMP Compliance: Botanical Identity & Herb Quality

cGMP Compliance: Botanical Identity & Herb Quality

Presented: September 28, 2006

Published: Thursday, September 28, 2006

How you handle botanical ingredient identity and quality is key to the products you’re manufacturing. Designed for companies that want to evaluate their ingredient identity and quality assurance systems, and prepare for new demands expected to be in FDA’s dietary supplement GMP rule. The materials from this AHPA educational tele-seminar will help you understand FDA’s proposed rules and how industry responded — giving you both the maximum and minimum expected standards that are on the horizon. Making Good Manufacturing Practice a part of your process sooner, rather than later, will ease the burden of compliance when final cGMP rules are issued.

What you’ll learn from these experts:

  • Lynda Hammons,Vice-present of Quality and Regulatory Affairs at Nature’s Sunshine Products — gives practical advice on setting and using standards, how to set ingredient specifications and select vendors, and shares a practical Raw Materials Testing Criteria Flow Chart
  • Sidney Sudberg, DC, LAc, RH (AHG), Director of Alkemists Pharmaceuticals, Inc. — explains Good Laboratory Practice, quality control, various analytical techniques for ingredient characterization and standardization, and case studies.
  • Roy Upton, RH (AHG), Executive Director of the American Herbal Pharmacopoeia, Vice-president of the American Herbalists Guild — reviews the legal requirements and expectations, and details physical tests (macroscopic characterization, microscopy), chemical tests (HPTLC, HPLC, FTIR, NIR), methods validation, documentation, sampling

Materials in this packet include:

  • A practical Raw Materials Testing Criteria Flow Chart
  • Course Outline, Speakers’ Presentations & Bios
  • Transcript, including answers to questions posed by attendees
  • Audio file
Member Price: $220.00
Non-Member Price: $520.00

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