中国临床药学杂志

目的 对复方乳酸依沙吖啶溶液进行质量回顾分析,评价其产品质量和生产工艺稳定性,并通过质量风险管理工具,前瞻性规避风险,持续提升药品质量。方法 运用Minitab软件中的能力六合图,以有效成分乳酸依沙吖啶含量、间苯二酚含量为指标,回顾分析2019年1月至2022年12月生产的共29批复方乳酸依沙吖啶溶液质量,评估其工艺过程是否稳定、过程能力是否充分,随后基于风险管理理念,借助失效模式与效应分析(FMEA)对潜在风险进行前瞻性管理。结果 29批次复方乳酸依沙吖啶溶液均符合质量标准,工艺均处于受控状态,但仍有潜在质量风险,借助FMEA发现人员和环境是关键风险因素,并针对性提出了有效应对措施。结论 联合Minitab和FMEA工具,对复方乳酸依沙吖啶溶液进行产品质量回顾和质量风险分析,能够及时识别产品质量趋势、风险点及改进点,有助于持续性保证药品质量安全有效、稳定可控。

AIM To review and analyze the quality of compound ethacridine lactate solution, evaluate the product quality and production process stability, and avoid risks and continuously improve the quality of drugs through quality risk management tools. METHODS Using the capability hexagrams in Minitab software, a total of 29 batches of compound ethacridine lactate solution produced from January 2019 to December 2022 were analyzed in a quality review using the active ingredient estradiol lactate content and resorcinol content as indicators to assess the stability of the process and the adequacy of the process capability, followed by prospective management of potential risks based on the concept of risk management with the help of failure mode and effect analysis(FMEA). RESULTS All the 29 batches of compound ethacridine lactate solution met the quality standard and the process was under control, but there were still potential quality risks, and personnel and environment were found to be the key risk factors with the help of FMEA, and effective countermeasures were proposed. CONCLUSION Combined with Minitab and FMEA tools, the product quality review and quality risk analysis of the compound ethacridine lactate solution can identify product quality trends, risk points and improvement points in a timely manner, which helps to ensure the drug quality is safe, effective, stable and controllable in a sustainable manner.