ValSource, Inc., 918A Horseshoe Pike, Dowingtown, PA 19335
PDA J Pharm Sci Technol. 2020 May-Jun;74(3):359-366. doi: 10.5731/pdajpst.2019.010462. Epub 2019 Nov 15.
Visible particulate matter contamination is responsible for the rejection or recall of numerous batches of injectable product each year. The result is wasted time, effort, money, product and the limited availability of medically necessary drug and biologic products. Recently published compendial standards have alleviated some of the confusion surrounding suitable test methods and acceptance criteria for visible particulates; however, the complexities of visual inspection methods across a wide range of injectable product types packaged in diverse and sometimes complex container systems has complicated the approach to visible particulate control in injectable products. The solution is a life-cycle approach to visible particulate contamination control that addresses the prevention, inspection, identification, and remediation of visible particulate contamination. More importantly, the life-cycle approach to visible particulate control is aligned with current United States Food and Drug Administration's good manufacturing practices and can serve as an effective tool for demonstrating regulatory compliance for inspections, audits, and regulatory submissions.
可见颗粒物污染每年都会导致大量批次的注射产品被拒收或召回。这不仅浪费了时间、精力和金钱，还导致了产品短缺以及一些必要药物和生物制品的供应受限。最近发布的药典标准缓解了一些围绕可见颗粒物适用测试方法和验收标准的困惑；然而，在各种包装在不同且有时复杂容器系统中的注射产品类型中，视觉检查方法的复杂性使得注射产品中可见颗粒物控制的方法变得复杂。解决方案是采用生命周期方法来控制可见颗粒物污染，该方法涵盖了可见颗粒物污染的预防、检查、识别和修复。更重要的是，采用生命周期方法来控制可见颗粒物污染符合当前美国食品和药物管理局的良好生产规范，可以作为一种有效的工具，用于展示检查、审计和监管提交的合规性。
