Other Technical Regulations

Additional Regulatory RequirementsI. Why do we have so many regulations? II. What are Current Good Manufacturing Practices (cGMP)? A. cGMP for Dietary Supplements B. cGMP for Pharmaceuticals C. Why are cGMPs important? D. What are my cGMP responsibilities? III. Hazard Analysis and Critical Control Point (HACCP) – What is it? A. Why is HACCP important? B. What are my HACCP responsibilities? IV. Kosher V. Halal VI. GMO/NON-GMO/IP VII. Irradiation Certification VIII. BSE/TSE IX. Japan Food Additives Regulations X. Therapeutic Goods Administration (TGA – Australia) XI. National Health Products (NHP – Canada) XII. Helpful Web ResourcesI. Why do we have so many regulations?As a global company with products in over 40 countries, we must adhere to the rules and regulations for each market. Therefore, for certain products we require adherence to additional regulations and it is important that our suppliers keep us informed of not only changes they make to specifications, but also changes in their certification status. ***Please refer to ABG product specifications for details on these additional requirements. Return to TopII. What are Current Good Manufacturing Practices (cGMP)?Current Good Manufacturing Practices (cGMPs) are Food and Drug Administration regulations designed to protect the public from “adulterated” or potentially dangerous foods, drugs and cosmetics. cGMP regulations address issues relating to recordkeeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.Following are some of the rules and regulations used by ABG depending on how your material is used and the market the product is sold in.Return to TopVersion 2 1 Updated: April 2008 A. cGMP for Dietary SupplementsDietary supplement cGMPs are necessary to ensure that, if you engage in activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements, you do so in a manner that will not adulterate such dietary ingredients or dietary supplements. The provisions require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements.Additional dietary supplements guidance may be found on the Standardized Information on Dietary Ingredients website (below): http://www.crnusa.info/SIDI/index.html Return to TopB. cGMP for PharmaceuticalsPharmaceuticals cGMPs are necessary to ensure that, if you engage in activities related to manufacturing, processing, packing, or holding of drugs, you do so in a manner that will not adulterate such drugs. The provisions require manufacturers to evaluate the identity, purity, quality, strength, and composition of their products.Additional guidance may be found on the federal government website below: http://www.fda.gov/cder/dmpq/cgmpregs.htm Return to TopC. Why are cGMPs important?It is important to instill quality at every step of the process. Therefore, we need our suppliers to adhere to high quality expectations as they produce our raw materials or products. The following is a quote from the Dietary Supplement cGMPs:Well-established principles of cGMP require process controls at each step of the manufacturing process as early in the production process as possible. Quality cannot be tested into the product only at the end (Ref. 9). Instead, the quality of the dietary supplement must be built into the product throughout the manufacturing process; quality begins with the starting material and continues with the product being manufactured in a reproducible manner according to established specifications. It is not sufficient, nor effective, to rely solely on end Version 2 2 Updated: April 2008 product testing to assure the quality of the individual dietary supplement product sold to the consumer.1Return to TopD. What are my cGMP responsibilities?Vendors, Distributors, and Raw Material suppliers that provide raw materials to dietary manufacturers need to comply with Food cGMPs. However, Dietary Supplement cGMPs are recommended. Return to TopIII. Hazard Analysis and Critical Control Point (HACCP) – What is it?HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling to manufacturing, distribution and consumption of the finished product. This systematic approach is based on 7 principles and is used to identify, evaluate and control food safety hazards:2 Principle 1: Conduct a hazard analysis Principle 2: Determine the critical control points (CCPs) Principle 3: Establish critical limits Principle 4: Establish monitoring procedures Principle 5: Establish corrective actions Principle 6: Establish verification procedures Principle 7: Establish record-keeping and documentation procedures For more detailed information about HACCP requirements, please contact your SQD representative. Return to TopA. Why is HACCP important?These guidelines are important because they help us ensure the quality of our products by preventing adulteration or contamination.Return to Top1 US. Department of Health and Human Services. Food and Drug Administration. Current Good Manufacturing Practice in Manufacturing, Packaging,. 25 June 2007. 27 June 2007 <http://www.cfsan.fda.gov/~lrd/fr07625a.html>. 2 "Hazard Analysis and Critical Control Point Principles and Application Guidelines." FDA. 10 Mar. 2000. FDA/USDA/NACMCF. 14 June 2007 <http://www.cfsan.fda.gov/~comm/nacmcfp.html#defs>.Version 2 3 Updated: April 2008 B. What are my HACCP responsibilities?A HACCP Program is recommended as part of a supplier’s quality system for risk assessment.Return to TopIV. KosherKosher certification indicates that the source of the ingredients and the status of the production equipment used to produce the certified food meets kosher requirements. Some of our products may require Kosher certification, so it is important that our suppliers keep us updated on the Kosher certification status of their products.Please note that ABG only recognizes Kosher certification from a select few agencies, so please contact your Procurement representative to verify the validity of a certification agency. ***Please refer to ABG product specifications to verify whether Kosher certification is required for your product.Return to TopV. Halal Halal certification indicates that products are certified to be consumed by the Muslim population. Some of our products may require Halal certification, so it is important that our suppliers keep us updated on the Halal certification status of their products. Please note that ABG only recognizes Halal certification from IFANCA (Islamic Food and Nutrition Council of America). For more information please contact your Procurement representative. ***Please refer to ABG product specifications to verify whether Halal certification is required for your product.Return to TopVI. GMO/NON-GMO/IPWe believe in the consumer’s right to know whether products include genetically modified (GMO) products. Therefore, ABG requires that its suppliers certify the level of certainty of the GMO status of their products. Version 2 4 Updated: April 2008 Many markets have regulations requiring Non-GMO or IP materials, therefore certification and verification of the QA process may be required for some products. ***Please refer to ABG product specifications to verify whether GMO/IP certification is required for your product.Return to TopVII. Irradiation CertificationIt is our preference as a company, to not utilize materials that have been irradiated. In addition, many international markets have regulations limiting and/or prohibiting irradiation in food/food supplement products. Therefore, ABG does not accept product that has been treated with radiation and requires that all of its suppliers provide an irradiation certification for every shipment. Certification can be made on the C of A or as a separate document, but it must be presented with shipping documentation. Return to TopVIII. BSE/TSEBovine derived materials (i.e. gelatin, milk or milk derivatives etc…) are highly regulated in many markets and may have restrictions on processing method and/or the country of origin. In an effort to ensure that we meet regulations in our international markets, ABG requires that all suppliers of bovine derived materials originating from outside the US provide BSE Certification from the country of export and an import certificate from the USDA at time of shipment. For materials that are used in products destined for some of the more restrictive markets, certification may be required for every shipment and must be presented with shipping documentation. For additional information on these regulations please contact your Procurement representative. ***Please refer to ABG product specifications for requirement status. Return to TopIX. Japan Food Additives RegulationsFood additives are highly regulated in Japan and only a select number are allowed to be used for products sold in Japan. Materials or products destined for the Japanese market will need to abideVersion 2 5 Updated: April 2008 by these regulations. If prohibited materials are naturally occurring, please provide documentation. For additional information on how these regulations please contact your Supplier Quality Development representative.***Please refer to ABG product specifications for requirement status. Return to TopX. Therapeutic Goods Administration (TGA – Australia)Certain ABG nutrition and food products are sold in the Australian market, which requires certification by the TGA. Therefore, certain ABG contract manufacturers that produce finished good items must be certified by the TGA. Your Procurement representative will notify you if you need to meet this requirement.Return to TopXI. National Health Products (NHP – Canada)Certain ABG nutrition and food products are sold in the Canadian market and therefore, some of our contract manufacturers must be certified by the NHP. Your Procurement representative will notify you if you need to meet this requirement.Return to TopXII. Helpful Web ResourcesSUBJECT HYPERLINK21 CFR – Parts 210 & 211 http://www.fda.gov/cder/dmpq/cgmpregs.htm The Ten Principles of GMP http://www.gmp1st.com/princip.htm Framework for Integrating Standards and http://www.gmp1st.com/framew.htm Regulations GMP and Quality Management http://www.gmp1st.com/qualman.htm Guide to Self Inspection http://vm.cfsan.fda.gov/~dms/selfinsp.html Hosting FDA Inspections http://www.gmp1st.com/hostinsp.htmVersion 2 6 Updated: April 2008 Dietary Supplement Industry Resource Center http://www.gmp1st.com/dsind.htm FDA Center for Drug Evaluation and Research http://www.fda.gov/cder/ FDA Center for Food Safety and Applied http://www.cfsan.fda.gov/list.html Nutrition FDA Final Rule for Dietary Supplement http://www.cfsan.fda.gov/ cGMPS %7Elrd/fr07625a.html Standardized Information on Dietary http://www.crnusa.info/SIDI/index.html Ingredients website (Dietary Supplement cGMP Information) FDA Guide to HACCP Principles and http://www.cfsan.fda.gov/~comm/nacmcfp.htm Application Guidelines l#princ FDA HACCP Website http://www.cfsan.fda.gov/~lrd/haccp.html Star K Kosher Certification http://www.star-k.org/ IFANCA Home Page http://www.infanca.org IFANCA Halal Certification Procedure http://www.ifanca.org/procedure/ TGA Home Page http://www.tga.gov.au/ NHP Canada Home Page http://www.hc-sc.gc.ca/index_e.html Overview of the Canadian Natural Health http://www.hc-sc.gc.ca/dhp- Products Regulations mps/prodnatur/legislation/docs/regula- regle_over-apercu_e.htmlReturn to TopVersion 2 7 Updated: April 2008

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