Trade group American Herbal Products Association (AHPA) said the guide is its “most recent GMP compliance tool”, and includes customizable standard operating procedure (SOP) templates.
Good Documentation Practices: A Guide for the Dietary Supplement Industry is one of many initiatives launched by dietary supplement trade groups in an attempt to help their members understand and comply with FDA’s much-criticized Good Manufacturing Practices regulation.
The regulation, which is being phased in since June 2008, is designed to provide standards specific to supplements for purity, safety and legality in manufacturing. However, the rule has so far provided more headaches than clarity, as manufacturers struggle to interpret it and to meet all documentation requirements.
Documentation is all
According to AHPA, “during an average FDA inspection, at least 50 percent of the time will be spent on documentation review - and as the 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 group said its 68-page GDP manual explains the principles of good documentation practices, provides step-by-step instructions for many documentation-related processes, and provides over 50 user-modifiable SOP templates.
“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,” said AHPA.
The manual is on sale for AHPA members at $250, and for non-members at $500. According to AHPA, it should help companies:
- Provide appropriate documentation to control and reflect company operations
- Facilitate document creation, approval, issuance, retrieval, and revision
- Prevent record falsification and minimize errors
- Facilitate records filing, retention, purging, and destruction efforts