在资格关键供应商的考虑因素
1Restore Health Consulting LLC, Laguna Beach, California. info@restorehealthconsulting.com.
International journal of pharmaceutical compounding
|December 15, 2023
概括
新的美国药典 (USP) 标准要求化合物制造商从FDA注册的设施获得活性药物成分和辅助剂. 药房现在必须实施强有力的供应商资格认证流程,以确保质量和合规性.
科学领域:
- 制药复合剂 制药复合剂
- 监管合规性 监管合规性
- 质量保证 质量保证 质量保证
背景情况:
- 即将到来的美国药典 (USP) <797>和 <795> 修订要求在FDA注册的设施采购活性药物成分 (API) 和辅助剂.
- 美国食品和药物管理局 (FDA) 建议化合物制造商对其批量API和辅助剂供应商进行审查.
- 监管机构越来越多地要求503A复合药房展示供应商资格程序,反映503B外包设施的要求.
研究的目的:
- 指导药店建立和实施有效的供应商资格认证计划.
- 确保关键的供应和服务符合质量和合规规范.
- 为不断变化的监管期望准备复合者,以适应有关供应商监管的不断变化的监管期望.
主要方法:
- 对即将发布的USP<797>和<795>指导方针进行审查.
- 分析FDA对供应商知识的建议.
- 讨论应用于供应商资格的质量保证原则.
- 审查监管和认证机构对503A组合物的期望.
主要成果:
- 药房需要主动开发并将供应商资格纳入其质量保证框架.
- 了解和审查供应商对于遵守新的USP标准至关重要.
- 展示对供应商资格的系统方法正在成为标准期望.
结论:
- 实施全面的供应商资格计划对于药房来说至关重要,以满足新的监管需求.
- 积极的供应商管理可以提高复合药品的质量和安全性.
- 采用这些做法可以确保合规性,并加强整体质量保证计划.
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