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听众
性别保密
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发表于 2017-9-18 13:55:01
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选自PDA TR29
Once the drug substance is sealed in its primary packaging, the risk of cross-contamination is gener-
ally relatively low. Cleaning processes should be used on the packaging lines after primary packaging,
but do not require cleaning validation. The main concern with cross-contamination is a compromised
primary package (such as a broken vial or a crushed bottle) that might release product that transfers
to the outside of the primary packaging of a different product. Depending on the hazard properties
of the product, its presence on the outside of the primary packaging of a different drug product
may be an unacceptable risk. Cleaning processes for such situations should be considered. However,
because contamination of the next product may only involve contamination of the outside of the
primary package, the requirements for cleaning validation should be assessed based on risk to patients
or to people handling the vials from that external contamination on the primary package. In those
cases where the risk is significant (such as a genotoxic API), a dedicated line or a cleaning step known
to remove, deactivate or degrade that active drug should be considered. Degradation processes may
appropriately be confirmed in a laboratory study demonstrating degradation or inactivation of the
highly hazardous API.
我个人认为可能青霉素类是不被允许的（仅仅只有青霉素的药品是法规强行要求独立厂房或设施的），但是其他highly hazardous的药品应该是可以的（这个还得基于风险评估）。
但是有一个前提是必须人用药品，如果是兽用药品，关于青霉素类是否专线是没有要求的（因为关于动物的青霉素致敏应该是没有这个问题的，可以参见FDA GMP preamble 1978相关资料）
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