Contamination Controls: Preventing Adulteration in Generic Drug Manufacturing
Contamination controls in generic drug manufacturing prevent harmful adulteration through strict cleanroom standards, validated cleaning, real-time monitoring, and human error reduction-ensuring patient safety and regulatory compliance.
Bioequivalence Studies: What the FDA Requires Manufacturers to Prove
The FDA requires generic drug makers to prove bioequivalence through strict pharmacokinetic studies showing their product matches the brand-name drug in absorption and blood levels. Learn how the 80/125 rule, biowaivers, and NTID guidelines ensure safety and effectiveness.