gmp compliance and documentation
GMP (Good Manufacturing Practices) provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use.
These requirements ensure order and control over suppliers, components, processes, and distribution of products. They exist to minimize the likelihood of poor quality or unsafe items entering the supply chain for a variety of industries. Many herbal businesses must adhere to Dietary Supplement GMPs.
As an owner or operator of one of these businesses, you must have documented proof of your adherence to relevant GMPs. Navigating the GMP regulation published in 21 CFR (code of Federal Regulations) 111 is overwhelming and confusing for anyone!
That’s why we offer support.
Included with each download:
· a worksheet to help assess your current level of compliance to the specific regulation;
30 minute personalized training session resulting in a custom implementation path;
· a form to categorize your products into their respective regulation status;
· instructions detailing next steps, helpful notes, and recommendations; and
· listed SOPs and Forms addressing the relevant subpart.
From Anne, our GMP expert:
“My goal, first and foremost, is to offer products and a service to small herbal products companies who find meeting the regulation cost prohibitive and daunting. Using the documents with the associated DIY instructions may be enough for some. For others, education and support as they navigate the regulated world may be more appropriate. Working on a timeline that fits the user is critical to ensure understanding and ultimately successful implementation of the regulation.”
Feeling ready?
not sure where to begin?
