FDA Required Documentation
It took FDA a decade after the adoption of the Dietary Supplement Health and Education Act (DSHEA) in 1994, and amendments, to establish a series Regulations governing the dietary supplement business. With AER (Adverse Event Reporting), SOP (Standard Operating Procedures) and cGMP (Current Good Manufacturing Procedures) companies now find that the must keep certain crucial records, such as their Core Company Data Sheets (CCDS) and a host of logs, records and documents. My SOP system, vetted by previous FDA inspections of some of my clients, will make compliance easy.
FDA: "...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec. 111.14(b)(2) requires you to keep documentation of training, including the date of the training, the type of training, and the person(s) trained." Federal Register, page 34811
The Core Company Data Sheet is where you record essential features of each product and index the Claims Notice, Substantiation and other documents that record the details of your products.
In 2000 FDA issued the Structure and Function Claims Regulation which tells dietary supplement purveyors how they can make the ordinary support claims that are typical for dietary supplements. The Regulation requires companies to file Claims Notices with FDA for every claim they make for every product, by ingredient. The industry has not paid enough attention to this required Notice, but the FDA has begun to enforce the rule by expecting to see the proper Notices when the company is inspected, as all owners of labels will be.
FDA Good Manufacturing and Marketing Practices required dietary supplement purveyors to document the way they do business, since the companies are considered food-handling operations. This means thorough Standard Operating Procedures. My SOP format has been vetted by FDA inspection. The twenty SOPs cover the full scope of activities from sourcing ingredients, through manufacturing, packaging, shipping and customer service... all the factors over which the label-owner is expected by FDA to be "in a state of control." This document is essential for the operation of your business.
My standard employee manual, designed for the nutrient industry, can be fine-tuned for your company, whether you are a start-up or an established dietary supplement business.
Congress mandated that all "serious" adverse events be reported to the FDA. Do you know what incidents qualify? Most companies do not understand what is required. My SOPs and Certification training can help you be ready to deal with any claims of Adverse Events.
It is not enough to have written Standard Operating Procedures that put you in a cGMP "state of control." You must train your staff in using the SOPs and document the training. My SOP Certification Program, with its four Webinars, Open Book Certification Test and Certificate of Successful Completion meet the FDA requirements.