制药制造业中与Burkholderia cepacia复杂污染相关的挑战和缓解策略
Sethuraman Prem Kumar1, Karupanagounder Thangaraj Uthra2, Vellapandian Chitra3
1Department of Pharmaceutical Quality Assurance, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu, 603203, India.
Archives of microbiology
|March 14, 2024
概括
在制药生产中,Burkholderia cepacia复合物 (BCC) 构成重大风险,导致产品召回和感染. 本综述详细介绍了BCC污染,识别挑战以及药物生产中的风险管理策略.
科学领域:
- 微生物学 微生物学
- 制药科学 制药科学
- 传染性疾病 传染性疾病
背景情况:
- 伯克霍德里亚首帕西亚复合体 (BCC) 包含20多种在土壤和水中发现的机会性格兰阴性细菌物种.
- BCC的适应性和基因组可塑性使其能够在免疫功能受损的个体中引起严重感染.
- 在制药制造业中,BCC污染是一个主要问题,导致产品召回和疫情爆发.
研究的目的:
- 综合审查导致BCC污染的有机体.
- 讨论与BCC相关的遗传多样性和识别挑战.
- 概述制药制造业中BCC的监管要求和缓解策略.
主要方法:
- 科学数据库和监管指南的文献综述.
- 对BCC的遗传特征和病原性潜力的分析.
- 综合有关检测方法,风险因素和控制措施的信息.
主要成果:
- BCC物种表现出显著的遗传多样性,使识别复杂化.
- 对BCC的错误识别是常见的,特别是在资源有限的环境中.
- 全球众多产品召回和疫情与制药和个人护理产品中的BCC污染有关.
结论:
- 有效的BCC测试和鉴定对于监管合规和患者安全至关重要.
- 对制药制造商来说,实施强有力的风险管理和预防策略至关重要.
- 解决BCC污染需要采取多方面的方法,包括检测,控制和监管监督.
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