How to Comply with Drug CGMPs, 2nd EditionĀ 

Softbound | 100 pages
By Cathy L. Burgess and Daniel G. Jarcho
April 2017

Globalization in the pharmaceutical industry, expanded FDA authority over CGMPs, and increased scrutiny of data integrity, among other developments in this rapidly evolving field, make for a complex compliance environment.

This resource provides members of the legal community and regulated industry with a concise reference on the compliance standards and governing principles for current Good Manufacturing Practices.

Even as these standards will change over time, the underlying concepts discussed should help the reader understand these changes, and how to incorporate them into a robust compliance program.

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