SILVER SPRING, MD Dec. 2, 2009 – The American Herbal Products Association (AHPA) proudly announces the availability of its long awaited revision to the “AHPA Guidance on How to Conduct an FDA Inspection.”
Completely revised by AHPA President Michael McGuffin, AHPA General Counsel/Partner at Kleinfeld, Kaplan & Becker Tony Young, and Government Relations Committee Chair/VP of Quality at Cortex Scientific Staci Eisner, this important guidance will assist you before, during and after an inspector arrives at the door of your manufacturing facility and conducts an inspection.
Prepare yourself and your staff, and protect your company, by purchasing a copy of this comprehensive document in order to obtain a solid understanding of your rights and obligations, and the FDA's authority, during an inspection under the dietary supplement cGMP.
The 51-page guidance is broken down into four sections, presented in a question and answer format, and two appendices. It includes:
- Part 1 - an overview of FDA's inspection authority, which derives from the Federal Food, Drug and Cosmetic Act, the Public Health Security and Bioterrorism Preparedness and Response Act, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, the Reportable Food Registry requirements of the Food and Drug Administration Amendments Act, and the food and dietary supplement cGMPs (i.e., 21 CFR 110 and 111).
- Part 2 - the shortest but perhaps most essential section of this Guidance, as it provides suggestions on the steps that a firm should take in advance to be prepared for an FDA inspection.
- Part 3 - provides guidance on what should be expected during an inspection by FDA personnel.
- What information should an FDA inspector provide prior to conducting an inspection?
· What reasons are commonly given for an FDA inspection of a food ingredient or dietary supplement facility?
· What preparations should be made between the arrival of an inspector and the beginning of an inspection?
· What is meant by "refusing an inspection"?
· What policies and procedures should a facility follow during an inspection?
· Which facility employees should speak with an inspector?
· How should a request to examine and copy records be handled?
· How should a request for samples be handled?
· How should a request for the names and titles of key personnel be handled?
· How should a request for the names of customers and/or vendors be handled?
· How should a request to sign an affidavit be handled?
· Is it appropriate to provide meals or snacks to an inspector?
· Part 4 - discusses the observational findings that follow an inspection and the need to maintain a thorough internal record of each inspection.
- Appendix 1 - a template for establishing a written standard operating procedure for FDA inspections. This template incorporates much of the information contained in the main section of this Guidance.
- Appendix 2 - provides the relevant text of the laws and regulations upon which FDA's inspection authority is based.
The AHPA Guidance on How to Conduct an FDA Inspection can be purchased from the AHPA Bookstore: http://www.ahpa.org/Default.aspx?tabid=68. Please contact Devon Powell for more information: [email protected] and 301-588-1171 x102.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal products industry. AHPA is comprised of domestic and foreign companies doing business as growers, processors, manufacturers and marketers of herbs and herbal products, including foods, dietary supplements, cosmetics, and nonprescription drugs. Founded in 1982, AHPA’s mission is to promote the responsible commerce of herbal products. Website: www.ahpa.org