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Begin Checklist: __ All of our personnel have adequate and up to date regulation compliance training. __ Our personnel have the required training, education and experience to adequately perform their job functions. __ We comply with FDA, FTC and other applicable regulations and requirements. __ We have the written procedures, documents and records required by FDA and other federal, state and local laws and regulations. __ Our suppliers are inspected, audited, and approved, as part of our written supplier qualification / certification program. __ We have responsibility agreements in place with our suppliers. __ Our dietary supplement ingredients are legal; have history of use or NDI notifications are submitted. __ Our packaging complies with FDA requirements, in particular, packaging that our dietary supplements come in direct contact with. __ The ingredients or combination of ingredients are safe and effective for their intended use. __ Our products are not misbranded. __ Our products are not adulterated. __ Our Manufacturing, packaging, holding, or distribution operations are in compliance with FDA's Part 111 CGMP requirements. __ We have the data required by FDA to support our expiration dating. __ Our labels contain the required FDA label information, such as: statement of identity (descriptive name); content; Supplement Facts panel; etc. __ Our labels contain the required FDA warnings / disclaimer statements when warranted based on ingredients or product claims. __ Our labels comply with the FDA's layout and font size regulations. __ Our bottles / packaging have the required child resistant caps / seals when warranted. __ If our labels use "Structure Function" Claims, we have the required scientific substantiation in our records, prepared by expert(s), and have submitted to the FDA the required notification. __ We use FDA approved Health Claims correctly. __ Our Quality Control personnel conduct all of the required Part 111 CGMPs before releasing our dietary supplements for distribution to our customers. __ We have the required personnel and written procedures in place to deal with customer complaints and Serious Adverse Event reporting. __ Our testing uses scientifically valid methods and or validated methods. __ We have the sufficient number of our retained dietary supplement product samples stored under proper conditions according to Part 111 CGMP regulations and our product specifications. __ We have the required records on file for the time period required by FDA's Part 111 CGMP regulations. DIETARY SUPPLEMENT ONLINE, ON-DEMAND EFFECTIVE UP TO DATE CONVENIENT COMPREHENSIVE AFFORDABLE DIETARY IMPROVE YOUR CAREER IMPROVE YOUR BUSINESS |
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Begin Evaluation: If you answer "NO" to one or more of the following questions, you and/or your company's training & operational compliance obligations are probably not being met. Therefore your Business and Career can be improved with our Online, On-demand Training & Education Programs and Materials. Are you really prepared for a FDA inspection? Do you conduct FDA compliance self-audits on a regular basis (daily, weekly, monthly)? Is your company's personnel FDA training compliance program comprehensive? Is your company's training program up to date? Is your company's training program cost effective? Is your company's training program convenient? Is your company's training program designed to minimize operational disruptions? Do you have the written procedures, documents and records required by FDA, FTC and other regulations? Do you have the required SOP and proof of supplier qualification and approval? Are your dietary supplement products misbranded or adulterated? Are your ingredients legal or do they require a NDI notification? Do you have data to support expiration dating? Are your finished products tested? Is your customer complaint SOP and files compliant with FDA regulations? Do you have a complete master file for you dietary supplement products, containing, raw material COAs, all testing methods, product specifications, proof of Part 111 CGMP compliance, legal labeling, legal claims substantiation, safety information, efficacy information, etc.? Part 111 CGMP compliance is required if your company makes dietary supplements, has someone else make them for you, and if you are involved in holding them in a warehouse and distributing them too; is your Company fully Part 111 CGMP compliant? There are a host very specfic label / labeling requirements that dietary supplement and their design companies need to know about, do you have training and written procedures in place to ensure this is happening? Do you know what happens if you make claims on your labels, do not have the substantiation and did not submit the proper notification to FDA? Does your company have Serious Adverse Event procedures in place? Is adequate scientific evidence on file at your company to satisfy FDA and FTC claims substantiation requirements? For dietary supplement products containing Structure Function claims, did you send to FDA the required notification? Product label / packaging fonts have minimum and maximum size requirements, some are flexible and related to the surface area of the label or packaging, do your product labels meet FDA's label format requirements? Are you taking advantage of using FDA approved Health Claims, which allow claims for how ingredients may reduce the risk of certain diseases, such as cardovascular diseases, osteoporosis, and even certain cancers? Do you have the required Quality Control personnel and written procedures in place? Are your dietary supplement products labels, "labeling" and advertising legal and with the required substantiation at your company? Do you have proof that your contract manufacturing companies comply with Part 111 CGMP regulations and satisfy your company's product quality standards and FDA compliance requirements? Do you have all the documentation / records required by Part 111 CGMP, related to your operations? | ||
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