Risk-Based Approach in GMP

Good Manufacturing Practices (GMP) are the backbone of pharmaceutical quality. They ensure that every tablet, vial, and injectable product is consistently safe, effective, and manufactured under controlled conditions. But like everything else, the expectations around quality systems evolve with time—and so must the regulations guiding them. The initiation of the "Risk-Based Approach" on August 21, 2002, has transformed how both the FDA and the pharmaceutical industry approach quality, compliance, and manufacturing decisions. The core idea was simple but powerful: Use risk-based…