Incorporating Data Integrity into Your Pharmaceutical Quality Management System

By Anthony Warchut, Vice President, Technical, PAREXEL

ICH Q10, Pharmaceutical Quality Systems was recommended for adoption to the regulatory bodies of the European Union, Japan and the United States in 2008. EMA then formally approved it that same year. In 2009, the U.S. FDA adopted it as a guidance document. This begs the following question, if companies have adopted the principles of ICH Q10, why have the FDA and EMA been experiencing an increase in the number of data integrity issues found during recent inspections?