SILVER SPRING, Md.—The American Herbal Products Association (AHPA) released its “Good Documentation Practices Manual: A Guide for the Dietary Supplement Industry.” The 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.
During an average FDA inspection, 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 GMPs (good manufacturing practices), 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 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 ISO registered companies, and are also relevant to food and food ingredient facilities.
The information contained within the manual should assist with:
- Providing appropriate documentation to control and reflect company operations
- Facilitate document creation, approval, issuance, retrieval, and revision
- Preventing record falsification and minimize errors
- Facilitate records filing, retention, purging, and destruction efforts