Good Manufacturing Practices Q&A
-
Here are two questions that deal with a similar topic—the responsibilities of companies that hold products: Question #1: Vibrant Health is a holder of finished dietary supplements. We purchase all ingredients and have our NSF CGMP contractors blend and bottle. We have 11 employees. What do the CGMP rules require us to do as holders of finished product? What is the date by which we need to be in compliance? Question #2: What are the requirements, and where can we learn more about them if we are just a tiny mail-order telephone/online order company that has our own formulas. We have an independent manufacturer, and we just store and sell the products. But we have no retail outlet. How do we learn what applies to us and how to write the SOPs?Answered May 17th, 2010 by Expert:If you are strictly a retailer, the exemption in section 111.1 Paragraph b applies. It appears that both questioners are holding or warehousing product. In this case, each company as a holder of dietary supplements would be subject to the regulations of 21 CFR Part 111 as is anyone if they “manufacture, package, label, or hold a dietary supplement.” As a holder of supplements, all regulations apply, but specific sections of the regulations that you should be familiar with include sections 111.453–111.475 Holding & Distributing.
Vibrant Health, you mentioned that you also purchase the ingredients that are then contract manufactured into the dosage products. The ingredients themselves require special handling and testing requirements, some of which are outlined in sections 111.153–111.180. Ingredients, at a minimum, need to be tested for identity. In addition, a supplier qualification program for these ingredients must be maintained. Keep in mind that a small company, defined as having fewer than 20 employees, has until June 25, 2010, to comply with the regulations.
Two great resources for understanding the regulations and helping you with compliance are DBA and NSF.
Leave a reply




