Welcome to CGMP Issues

Welcome to my new blog -- CGMP Issues.  CGMP stands for current Good Manufacturing Practices, and specifically refers to the U.S. Code of Federal Regulations, Parts 111 (dietary supplements), 210/211 (pharma), and 820 (medical devices). We will discuss points of interest to the U.S. FDA-regulated industries, focusing on medical devices, but with some elements of pharmaceuticals, combination products, dietary supplements and related.  Please indicate your company's areas of concern and we will try to address them or direct you to the appropriate resource.  

The information provided in this blog is taken from sources and material which we believe to be reliable, and/or express the opinions of the writers and/or presenter.  In such condensed and generalized form, the material certainly should not be considered a complete study or report on the subject mater, especially as to how  it might relate to a specific company / user’s application.  Conclusions are based solely on available data, and the judgments and analysis of technical factors offered are not intended to replace the utilization of additional research and/or appropriate professional counsel in adapting material to a specific application.

© 2019  by J. E. Lincoln & Associates LLC.  All rights reserved.  Reproduction in whole or in part without written permission is prohibited. 

See my website:  http://www.jelincoln.com/