Quality Management

Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) current good manufacturing practices (cGMP) regulations. Pharmaceutical manufacturers must ensure data is reliable and [...]

Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. However, it’s an area where many pharma manufacturers still struggle. In fact, 30 percent of FDA pharmaceutical [...]

The global pandemic brought an unexpected change  – FDA remote regulatory assessments (RRA). The FDA wants to expand RRA across all product areas to supplement in-person inspections after it has [...]