Most FDA data integrity findings trace back to one quality system gap, not bad actors. See what inspectors expect and how to close it before an audit.

Common GMP risks in non-sterile pharmaceutical manufacturing include cross-contamination, weak cleaning validation, utility control gaps and data integrity issues. Here is what to watch.

A new EMA Q&A points non-sterile manufacturers toward Contamination Control Strategy principles. Here are the technical and organisational measures it expects, and how to respond.