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成品檢驗不合格，或者成品入庫后發(fā)生微生物污染事件，一定不能放行嗎？

 

近日，澳大利亞藥監(jiān)局發(fā)布了關于申請不合格生物產品例外放行的文件，文件允許在規(guī)定的情況下異常放行不合格的生物產品。

 

文件將不合格生物產品定義為那些不符合生物產品放行的所有常規(guī)質量或生產要求的生物產品。

 

文件規(guī)定這種例外放行適用于生物產品來自合格供體，但在生產中因成品不符合放行標準或在儲存后檢測到生物負荷等原因，被判定為不合格。不適用于從不合格供體中故意收集和儲存的組織。

 

文件同時舉例說明不合格生物產品例外放行的情況：

 

瓣膜庫為危重嬰兒提供兒科心臟瓣膜，但無法等待 10 天獲取組織微生物檢測結果。

 

該兒科心臟瓣膜不符合所需的安全標準或當前生產標準，但由于緊急情況，申辦方可以根據(jù)例外放行條款放行產品

 

摘譯如下：

 

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.

 

如果您是澳大利亞醫(yī)療用品登記處（ARTG）中包含的生物的申辦者，并且您需要放行不符合所有通常安全或制造標準的產品，那么您需要申請批準不合格生物產品的例外放行。

 

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

 

僅在規(guī)定的情況下和針對個別患者才允許異常放行不合格的生物產品。

 

Information on this page outlines:

 

本頁信息概述：

 

the prescribed circumstances when exceptional release is  permitted

 

允許例外釋放的規(guī)定情況

 

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

 

申辦者在提供不合格生物之前和之后的責任

 

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

 

如何訪問和填寫特殊授權請求的表格。

 

Prescribed circumstances for exceptional release

 

允許例外放行的情況

 

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

 

要進口、出口或供應不合格生物產品，必須符合以下所有標準：

 

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

 

患者經由其執(zhí)業(yè)醫(yī)師評估急需生物治療嚴重疾病

 

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

 

沒有或在治療所需的時間內沒有合適的等效替代方案

 

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

 

該不合格生物產品在澳大利亞醫(yī)療用品登記處（ARTG）登記

 

no other treatment option is suitable for the patient

 

沒有其他治療方案適合患者

 

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

 

不合格生物產品被評估為最適合患者的治療方案

 

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

 

該不合格生物產品只能用于治療一名患者

 

Non-conforming biologicals

 

不合格生物產品

 

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

 

不合格生物產品是指那些不符合生物產品放行的所有常規(guī)質量或生產要求的生物產品。

 

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產品通常會從符合強制性供體標準的供體那里收集，但在后續(xù)生產中被認定為不合格（例如不符合放行標準或在儲存后檢測到生物負荷）。

 

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.

 

例外放行不適用于從已知不符合強制性供體接受標準的供體中故意收集和儲存的組織。

 

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.

 

瓣膜庫為危重嬰兒提供兒科心臟瓣膜，但無法等待 10 天獲取組織微生物檢測結果。

 

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.

 

該兒科心臟瓣膜不符合所需的安全標準或當前生產標準，但由于緊急情況，申辦方可以根據(jù)例外放行條款放行產品。