White Paper on Dietary Supplements

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Final FDA Rule on Dietary Supplements (21 CFR Part 111) <strong>White</strong> <strong>Paper</strong> Benefits of customer complaint software: A customer complaint software solution automates the process of documenting, reviewing and, when necessary, investigating customer complaints. The process of investigating complaints is greatly expedited by the ability to launch a review/approval routing (with all relevant documents attached). This prevents delays in resolving complaints due to the paperwork not being complete. Another benefit is that complaint records stored in secure, centralized electronic files can be easily retrieved by authorized users. They can also be automatically retrieved by the system to print reports, perform analyses, etc., which help companies to see trends and respond proactively. In summary, an automated document control/management system and automated processes can help assure quality and regulatory compliance, proper documentation, and greatly speed up the processes involved in the production of dietary supplements. References 1. FDA information about the recall can be found at the following URL, downloaded March 25, 2008, from http://www.fda.gov/oc/po/firmrecalls/nasutra09_06.html 2. FDA information about the recall can be found at the following URL, downloaded March 25, 2008, from http://www.fda.gov/oc/po/firmrecalls/fiberchoice03_07.html 3. Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts. Downloaded March 25, 2008, from the following URL: www.cfsan.fda.gov/~dms/dscgmps6. html 4. Mei-Chih Lin, Yoe-Ray Ku, Yi-Chu Liu, Jer-Huei Lin. P-090: Isolation and Identification of a novel Sildenafil analogue adulterated in herbal supplements. Bureau of Food and Drug Analysis, Department of Health, Taipei, Taiwan. Retrieved: March 31, 2008 from http://www.phcog.org/ AnnualMtg/2006/papers/P_090.pdf 5. Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Downloaded on March 25, 2008, from http://www. cfsan.fda.gov/~dms/dsaergui.html#def 6. Adverse event reporting form. Retrieved March 31, 2008 from the following URL: http://www.fda. gov/medwatch/getforms.htm. 10
<strong>White</strong> <strong>Paper</strong> About MasterControl MasterControl Inc. is a global provider of GxP process, quality audit, and document management software solutions for life science companies. MasterControl products are easy to use, easy to deploy, easy to validate, and easy to maintain. They incorporate industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies, including 50 percent of the top 20 pharmaceutical enterprises, currently use MasterControl solutions for easier compliance, faster validation, and better process management. For more information about MasterControl, visit www. mastercontrol.com, or call 800-825-9117 (U.S.) or +44 118 9812838 (Europe). Final FDA Rule on Dietary Supplements (21 CFR Part 111) © 2008 MasterControl Inc. All rights reserved. 11
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