During an average inspection by the Food and Drug Administration (FDA), at least 50 percent of the time will be spent on documentation review – and as FDA likes to say, "If it isn't documented, it didn't happen."
One of the keys to compliance with 21 CFR 111, the dietary supplement Good Manufacturing Practices (GMP), will be strong documentation and records retention, including the development and maintenance of standard operating procedures (SOPs) for many manufacturing and related business aspects.
The American Herbal Products Association (AHPA) is proud to announce the availability of its most recent GMP-compliance tool, "Good Documentation Practices: A Guide for the Dietary Supplement Industry." This 68-page manual explains the principles of good documentation practices, provides step-by-step instructions for many documentation-related processes, and provides numerous examples and templates that can be easily modified for use by your company.
The manual focuses on documentation systems in the context of manufacturing, packing, or holding dietary supplements. Although the principles and many of the procedures and forms overlap with documentation practices used by drug and International Organization for Standardization (ISO)-registered companies, they are also relevant to food and food ingredient facilities.
The information contained within the manual should assist your company with:
• Providing appropriate documentation to control and reflect company operations
• Facilitating document creation, approval, issuance, retrieval, and revision
• Preventing record falsification and minimizing errors
• Facilitating records filing, retention, purging, and destruction efforts.
Please contact Devon Powell ([email protected]; 301-588-1171 x102) for more information or to obtain your copy. The manual is also available for sale in the AHPA bookstore: http://www.ahpa.org/Default.aspx?tabid=68.
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.