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Article: Packaging processes under the FDA: compliance with FDA's 21 CFR Part 11 allows products to be made right the first time. Manufacturing execution system (MES) software can streamline, authenticate and control.(AUTOMATION THEORY)
- Article from:
- Packaging Digest
- Article date:
- May 1, 2007
- Author:
CopyrightCOPYRIGHT 2007 Reed Business Information, Inc. (US). This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Once pharmaceutical and personal care products manufactured, they still need to be measured into doses and packaged properly. In this discrete part of the process, specific regulatory compliance and documentation issues apply under the umbrella of U.S. Food and Drug Administration (FDA) 21 CFR Part 11. This rule applies to any records in electronic form that are used to satisfy any FDA requirement, and it includes the mandate to generate accurate and complete batch records in both electronic and human-readable form. In two examples here, manufacturers find that complying with 21 CFR Part 11 delivers business benefits--namely, greater control over plant-floor ...
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Article: LIMS2000 and 21 CFR Part 11.(Brief Article)
Scientific Computing & Instrumentation;
August 1, 2000 ;
700+ words
... ... and Drug Administration's (FDA) 21 CFR Part 11 rule, which addresses the use of electronic ... many of the presentations touched on 21 CFR Part 11, the following papers were among those ... and Implementing Them to Comply with 21 CFR Part 11 Rules and Beyond. This reviewed CENSA ...
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