生物制药

有人认为是从主药投料之日起开始算，也有人认为应该是药品成品包装完成后开始算，请问大家的做法是怎样的?

看EMA怎么回答你



NOTE FOR GUIDANCE ON START OF SHELF LIFE OF THE FINISHED



DOSAGE FORM:



ANNEX TO NOTE FOR GUIDANCE ON MANUFACTURE OF THE



FINISHED DOSAGE FORM



The expiration period of a production batch should be calculated from the date of release of that batch.



失效期应该从放行日期开始计算。



The date of such a release should, under normal circumstances, not exceed 30 days from the date of production of that batch.



正常情况下，放行日期应该自批次生产日期不超过30天。



If batches are released exceeding 30 days from the production date, the date of production, as defined below, should be taken as the start of the shelf-life.



如果按照如下定义情况，批次放行日期超过生产日期30天，制造日期应该作为有效期开始起点。



The date of production of a batch is defined as the date that the first step is performed involving combining the active ingredient with other ingredients. For medicinal products consisting of a single active ingredient filled into a container, the initial date of the filling



operation is taken as the date of production.



一个批次制造日期应该定义为活性物质和其他辅料混合的第一步操作发生的日期。对于只含有一个活性成分，然后粉状进入容器的产品，生产日期就选择粉状日期为生产日期。



Note: This annex does not pertain to biological medicinal products such as vaccines, sera, toxins and allergens, products derived from human blood and plasma as well as medicinal products prepared biotechnologically.



这个指南不适用于生物制品等。

对于原料药，需要根据不同工艺，在自己SOP规定。



因为不同API，工艺差距甚大。

从生产日期那天开始算起。。

Thanks for above responses!

预防用生物制品有效期的标注按照国家食品药品监督管理局批准的注册标准执行，治疗用生物制品有效期的标注自分装日期计算，其他药品有效期的标注自生产日期计算。