FDA Stresses Risk Assessments in Q&A on cGMP, Process Controls

Drugmakers befuddled by manufacturing failures, such as product contamination by microorganisms, are urged to perform risk assessments and take preventive action, the FDA says. Risk assessments should be informed by an understanding of the microbial contamination vulnerabilities of the concerned product and should consider all possible contamination sources, the FDA said. These include drug components, naturally sourced materials and the working environment, according to a recently posted question-and-answer document on Level 2 current good manufacturing practice (cGMP) process controls.
Drug GMP Report