HOW TO COMPLY WITH FDAS CGMP IN A GRADUATE.ppt

How can I legally sell my dietary supplement in U. S. ? Find expert to consult for you Do FDA facility registration Check dietary ingredients, formulation change? should I file pre-market or post-market notification with FDA? Do I need USDA special permit? Design labels that FDA approves Develop testing methodologies Check all testing results for FDA compliance Provide all documentations Warehouse CGMP Careful about your ingredient HOW TO COMPLY WITH FDA’S CGMP IN A GRADUATE AND MONEY-SAVING WAY Presented by David Hsu New Century AAA Inc. New Century AAA Inc.Tel: (909) 861-7575, website: 新世紀公司提供以下有關醫療器材, 食品、健康食品、保健產品、藥物、及化妝品的諮詢顧問： ? * 美國FDA設施及產品登記, 受聘替外國公司做駐美代理 * 保健產品,藥物的 CGMP及食品的 GMP * 替外國公司物色經銷商及提供經銷的諮詢顧問 * FDA / USDA法令 ( 各種USDA 批准PERMIT / FDA 証件) * FDA 銷售 / 進口前批准(PMA, PMN, 510K 等等 / 加州政府証件 * 產品標籖 / 產品廣告(CLAIM)用詞 * 商標 / 專利 / 版權 / 條碼 / ＵＬ申請 * 專利技術服務 (由構想、實驗至寫成) * 醫療器材產品製程評價與改進品管系统 , HACCP,，Quality System及產品撤銷 * 產品安全評估 * 研究發展方案 / 配方與產品研究 * 產品化學與微生物研究 WHAT DOES CGMP CONTAINS CGMP – Current Good Manufacturing Practice It contains : (1) For importer / distributors: FDA registration, product formula compliance, label, packaging, chemical / microbial testing, ingredient COA, food safety data such as MSDS sheet, all documentation, customer complaint, recalls, FDA approved packaging material? warehouse CGMP, manufacturer’s CGMP (indirectly) etc. continues (2) For manufacturer: All above plus manufacturer related CGMP (will discuss in details later) U.S. Regulatory Agenciesoverseeing dietary supplements U.S. Food and Drug Administration (FDA) U.S. Department of Agriculture (USDA) Environmental Protection Agency (EPA) U. S. Customs The Federal Trade Commission (FTC) 6. State Regulatory Agencies Imports Traditional import operations have routinely focused on procedural mechanisms Product sampling Entry review of documents Issuance of various notices Traditional remedies are administrative Detentions and Refusals Exportation or destruction of refused