成品检验不合格，或者成品入库后发生微生物污染事件，一定不能放行吗？

近日，澳大利亚药监局发布了关于申请不合格生物产品例外放行的文件，文件允许在规定的情况下异常放行不合格的生物产品。

文件将不合格生物产品定义为那些不符合生物产品放行的所有常规质量或生产要求的生物产品。

文件规定这种例外放行适用于生物产品来自合格供体，但在生产中因成品不符合放行标准或在储存后检测到生物负荷等原因，被判定为不合格。不适用于从不合格供体中故意收集和储存的组织。

文件同时举例说明不合格生物产品例外放行的情况：

瓣膜库为危重婴儿提供儿科心脏瓣膜，但无法等待 10 天获取组织微生物检测结果。

该儿科心脏瓣膜不符合所需的安全标准或当前生产标准，但由于紧急情况，申办方可以根据例外放行条款放行产品

摘译如下：

Purpose

目的

If you are a sponsor of a biological included on the ARTG and you need to release a product that does not meet all of the usual safety or manufacturing standards, then you need to request approval for anexceptional release of a non-conforming biological.

如果您是澳大利亚医疗用品登记处（ARTG）中包含的生物的申办者，并且您需要放行不符合所有通常安全或制造标准的产品，那么您需要申请批准不合格生物产品的例外放行。

Exceptional release of a non-conforming biological is only permitted underprescribed circumstances and for an individual patient.

仅在规定的情况下和针对个别患者才允许异常放行不合格的生物产品。

Information on this page outlines:

本页信息概述：

the prescribed circumstances when exceptional release is  permitted

允许例外释放的规定情况

sponsor's responsibilities before and after supplying a     non-conforming biological

申办者在提供不合格生物之前和之后的责任

how to access and complete the form for an exceptional release     request.

如何访问和填写特殊授权请求的表格。

Prescribed circumstances for exceptional release

允许例外放行的情况

To import, export or supply a non-conforming biological,all the following criteria must apply:

要进口、出口或供应不合格生物产品，必须符合以下所有标准：

the patient has been assessed by their medical practitioner to     need the biological urgently to treat a serious condition

患者经由其执业医师评估急需生物治疗严重疾病

a suitable and equivalent alternative that is conforming is not     available or not available within the necessary time for treatment to     occur

没有或在治疗所需的时间内没有合适的等效替代方案

a non-conforming biological that is included in the ARTG is     available

该不合格生物产品在澳大利亚医疗用品登记处（ARTG）登记

no other treatment option is suitable for the patient

没有其他治疗方案适合患者

the non-conforming biological is assessed as the most suitable     treatment for the patient

不合格生物产品被评估为最适合患者的治疗方案

the non-conforming biological is to be used only for the     treatment of one patient

该不合格生物产品只能用于治疗一名患者

Non-conforming biologicals

不合格生物产品

Non-conforming biologicals are those that do not meet all the usual quality or manufacturing requirements for release of the biological.

不合格生物产品是指那些不符合生物产品放行的所有常规质量或生产要求的生物产品。

Product released under exceptional release will usually be collected from a donor who meets mandatory donor acceptance criteria but was deemed non-compliant during subsequent manufacture (such as not meeting release specifications, or bioburden detected after storage/banking).

在例外放行下放行的产品通常会从符合强制性供体标准的供体那里收集，但在后续生产中被认定为不合格（例如不符合放行标准或在储存后检测到生物负荷）。

Exceptional release is not intended for release of tissue knowingly collected and banked from donors known to be non-compliant to mandatory donor acceptance criteria.

例外放行不适用于从已知不符合强制性供体接受标准的供体中故意收集和储存的组织。

Example of exceptional release

例外放行示例

A paediatric heart valve becomes available at a valve bank for a critically ill baby, but it is not possible to wait 10 days for tissue microbial testing results.

瓣膜库为危重婴儿提供儿科心脏瓣膜，但无法等待 10 天获取组织微生物检测结果。

This paediatric heart valve does not meet the required safety standards or current manufacturing standards, but the sponsor can release the product under the exceptional release provision due to the critical circumstances.

该儿科心脏瓣膜不符合所需的安全标准或当前生产标准，但由于紧急情况，申办方可以根据例外放行条款放行产品。