www.fdanews.com/articles/143010-q-amp-a-on-cgmp-process-controls-stresses-risk-assessment
Q&A on cGMP Process Controls Stresses Risk Assessment
January 6, 2012
Drugmakers befuddled by manufacturing failures, such as product contamination by microorganisms, are urged to perform risk assessments and take preventive action, the FDA says.
Washington Drug Letter
Washington Drug Letter