The presence of impurities is the primary cause of safety related drug product recall. Clinical data generated during the drug discovery process may not be able to conclude the long-term safety of a drug. The best way to ensure drug safety is to control the associated impurities. It can be achieved by a clear understanding of the route and factors for impurity formation. Tight control on manufacturing, storage, and transport process can provide a beneficial effect on minimization of impurity generation. Control strategies employing quality by design and risk assessment-based approaches potentially enhance drug safety profile and, thereby, minimize product recalls. Prior understanding of key aspects of the safety profile of impurities, post-marketing surveillance criticalities, and establishment of constructive preventive strategies is the best way to minimize unwanted product recall due to associated safety issues. Effective preventive strategies should be designed and executed during the product manufacturing and supply chain process. The novelty of this article can be justified by the unavailability of any similar type of reports discussing the functional pathway of regulatory bodies aiming for effective control of drug impurities. This article contains novel, critical, and constructive prevention strategies to establish a robust safety profile of pharmaceutical products.

杂质的存在是安全相关药品召回的主要原因。药物发现过程中产生的临床数据可能无法断定药物的长期安全性。确保药物安全的最佳方法是控制相关杂质。它可以通过清楚地了解杂质形成的途径和因素来实现。对制造、储存和运输过程的严格控制可以对最大限度地减少杂质产生产生有益的影响。采用质量源于设计和基于风险评估的方法的控制策略可能会增强药物安全性，从而最大限度地减少产品召回。事先了解杂质安全概况的关键方面、上市后监督的重要性、建立建设性的预防策略是最大程度地减少因相关安全问题而导致的不必要的产品召回的最佳方法。应在产品制造和供应链过程中设计和执行有效的预防策略。由于没有任何类似类型的报告讨论旨在有效控制药物杂质的监管机构的功能途径，因此本文的新颖性是合理的。本文包含新颖的、关键的和建设性的预防策略，以建立强大的药品安全概况。由于没有任何类似类型的报告讨论旨在有效控制药物杂质的监管机构的功能途径，因此本文的新颖性是合理的。本文包含新颖的、关键的和建设性的预防策略，以建立强大的药品安全概况。由于没有任何类似类型的报告讨论旨在有效控制药物杂质的监管机构的功能途径，因此本文的新颖性是合理的。本文包含新颖的、关键的和建设性的预防策略，以建立强大的药品安全概况。