@
沐清风
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
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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.
@阳光蒲照
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。
@白bai
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。