【讨论】关于β-内酰胺类抗生素的共线生产问题

北重楼

某网友问：原车间生产头孢菌素类，现欲将该车间的设备经过清洗并进行验证后，转产碳青霉烯类。请问头孢菌素类和碳青霉烯类之间的这种转产是否符合GMP的规定？是否需要分别在专门的车间生产？

lllllyyyyy

版主，这两个应该不能共线的。
原因，请参考Non-Penicillin Beta-Lactam Drugs:A CGMP Framework for Preventing Cross-Contamination

xqliu

lllllyyyyy 发表于 2017-6-3 13:27
版主，这两个应该不能共线的。
原因，请参考Non-Penicillin Beta-Lactam Drugs:A CGMP Framework for Prev ...

他两不能共线，记得当年国家也发过文。

beiwei5du

As with penicillin, the section of a facility dedicated to manufacturing a sensitizing non-
penicillin beta-lactam should be isolated (i.e., completely and comprehensively separated) from
areas in the facility in which other products are manufactured.  This control applies to each of the
five classes of sensitizing beta-lactams; the area in which any class of sensitizing beta-lactam is
manufactured should be separated from areas in which any other products are manufactured,
including any other class of sensitizing beta-lactam.  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.