Poor API quality threatens a healthy supply

September 30, 2025

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Poor API quality—from low potency, uncontrolled impurities, or batch-to-batch variability—can undermine drug efficacy and safety, shorten shelf life, and lead to production delays, drug shortages, or recalls that disrupt the pharmaceutical supply chain and harm company reputations. Supply interruptions drive up costs due to extra quality control efforts, while repeated issues can damage market confidence and expose manufacturers to regulatory risks. Gaps often stem from poorly defined critical quality attributes (CQAs) and insufficient process understanding, which hinder impurity detection and control, resulting in out-of-specification results and manufacturing setbacks. Experts recommend a comprehensive API control strategy—including robust supplier qualification, validated analytical methods aligned with ICH guidelines, defined CPPs/CQAs, and a strong GMP-aligned quality management system—to safeguard supply integrity