Recent FDA activities emphasize compliance with 21 CFR 211 Subpart E for components and raw materials. The FDA has repeatedly stated: all raw materials must receive at least an ID test to confirm it is the correct material according to the HPUS, USP or other appropriate authority. Marketing companies have received warning letters about labeling controls and inventory practices. Manufacturers have been issued warning letters and FDA-483 inspection reports for failure to adequately control incoming materials including quarantine, release, evaluation and identity testing.

This seminar provides an overview for marketers and manufacturers of the regulations establishing the requirements for components, raw materials and labeling, starting with the establishment of specifications and covering receiving, sampling, evaluation and testing for release or rejection. The FDA has made written specifications, identity testing and labeling controls a mandate in its inspection of manufacturers.

Compliance in these critical quality areas is essential to the identity, quality and safety of homeopathic products and is the responsibility of private label marketers and manufacturers alike.

In this Seminar you will learn the importance of…

• Protecting your consumers and your business by meeting the FDA regulatory requirements for specifications, receiving, testing and evaluating components, labeling and raw materials
• Ensuring product quality with the establishment of material and component specifications
• Confirming raw materials with required identity testing
• Compliance with FDA ‘hot button’ inspection issues

Who Should Attend…

• Manufacturers, contract manufacturers and private label producers responsible for ensuring the compliance of homeopathic products
• QA/QC staff responsible for establishing specifications, sampling, evaluating and testing of components and materials
• Marketers of private label brands who are responsible for the compliance of their contract manufactured product’s quality, safety and labeling

AAHP Members will receive a discounted price by entering the Discount Code on Ordering Page.

FDA Current Hot Topics

Rachael Carlisle Roehrig, Ph.D. - Director of Technical and Scientific Affairs for the Regulatory and Scientific Affairs department of the Consumer Healthcare Products Association (CHPA), coordinator for CHPA’s Product Quality & Operations Workshop and the CHPA liaison to the Manufacturing Controls Committee. Rachael will present FDA regulations 21CFR 211 Subpart E – Control of Components and Drug Product Containers and Closures and requirements. She will discuss specific quality processes, requirements for specifications, documentation and required identity testing.

Eric Foxman, RPh –Executive Director for the AAHP, Board Member of the HPCUS, and consultant on regulatory and GMP issues with over 30 years of involvement in homeopathic pharmacy and manufacturing.  Eric will discuss the HPUS requirements for testing of starting materials, botanicals and chemical substances, and for finished tinctures, providing examples of material specifications and identity testing requirements.

Kevin Carrasco, VP – Speed Laboratory Inc Kevin will review the reasons for the use of USP and NF testing methods for most excipient and for some homeopathic ingredients. He will present examples of the identity testing requirements for some of the most common homeopathic product excipients and active ingredients and cover basics in good laboratory practices for manufacturers.

Individual topic purchase: Selected