FDA是否允许β-内酰胺类与其他产品共线?
生产管理GMP

该问题来自识林与IPEM联合公益讲座《FDA对GMP合规的要求》

2024-08-23 15:21 识林-树苗     
3个回答

其他老师已回答了,大部分情况是不可以共线。

我补充一下,以下情况是可以共线的:

见指南Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination的III. Recommendations,如只生产一种特定种类的β-内酰胺类化合物,则可以允许以阶段性生产和清洁作为充分的控制。

Manufacturing that is restricted to a specific class of beta-lactam compound (e.g., the cephalosporin family of products) generally would not mandate separate facilities and air handling systems, and could permit production campaigning and  cleaning  as sufficient control.

如果只生产一种特定种类的β-内酰胺类化合物(如,头孢菌素家族产品),一般不强制要求采取独立的生产设施和空气处理系统,可以允许以阶段性生产和清洁作为充分的控制。

2024-08-26 15:12 白bai     

β-内酰胺类药物可能引起与青霉素相似的过敏反应,包括潜在的严重过敏反应。

建议生产商使用独立的设施生产β-内酰胺类药物,以减少交叉反应相关的健康风险。

生产敏感β-内酰胺类药物的区域应与生产其他产品的区域完全隔离,并拥有独立的空调系统。

详情请参考:FDA指南

2024-08-24 08:59 阳光蒲照     

FDA建议青霉素类药品单独的生产设施,非青霉素β内酰胺的控制策略与青霉素类似,具体可参考FDA指南非青霉素 β-内酰胺类药物:用于预防交叉污染的 cGMP 框架

Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
非青霉素 β-内酰胺类药物:用于预防交叉污染的 cGMP 框架
FDA | 2022-06-23
https://lib.shilinx.com:443/u/c3izrn

III. RECOMMENDATIONS

Because of the potential health risks associated with cross-reactivity (cross-sensitivity) of beta-lactams, manufacturers should assess and establish stringent controls (including appropriate facility design provisions assuring separation) to prevent cross-contamination. Just as FDA considers the separation of production facilities for penicillins to be current good manufacturing practice, FDA expects manufacturers to treat sensitizing non-penicillin beta-lactam-based products similarly. Specifically, FDA recommends that manufacturers establish appropriate separation and control systems designed to prevent two types of contamination: (1) the contamination of a non-penicillin beta-lactam by any other non-penicillin beta-lactam, and (2) the contamination of any other type of product by a non-penicillin beta-lactam. Accordingly, FDA recommends that the area in which any class of sensitizing beta-lactam is manufactured be separated from areas in which any other products are manufactured, and have an independent air handling system.

2024-08-23 17:23 沐清风