欧盟发布EU GMP-附录2-2018修订版

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近日，欧盟委员会发布EU GMP 附录2《人用生物原料药与药品的生产》-2018修订版，修订版指南生效时间为2018-06-26，有关该修订版指南解读如下：

Scope:

范围

Current version:

现行版

This annex provides guidance on the full range of active substances and medicinal products defined as biological.

本附录为各种已经定义为“ 生物学的” 原料药与药品提供指导

Revision:

修订版

This annex provides guidance on the full range of active substances and medicinal products defined as biological, with the exception of Advanced Therapy Medicinal Products ("ATMPs"), as defined in Article 1(1) of Regulation (EC) No 1394/20071 . The ATMPs are not covered by the present guideline. Manufacturers of ATMPs should refer to the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products referred to in Article 5 of the above quoted Regulation.

本附录提供了关于定义为“生物学”的所有活性物质和医药产品的指导，但（EC）第1394/20071号条例第1（1）条规定的高级治疗药品（“ATMP”）除外。ATMP不在本指南的范围内。ATMP制造商应参考上述法规第5条中提到的“高级治疗药品特有的良好生产规范指南”。

Current version:

现行版

In certain cases, other legislation is applicable to the starting materials:

在某些情况下，其他法规适用于下述起始材料：

(a) Tissue and cells used for industrially manufactured products (such as medicinal products):

用于工业化生产产品（例如，药品）的组织和细胞

Revision:

修订版

In certain cases, other legislation is applicable to the starting materials. For example,

在某些情况下，其他立法适用于下列起始物料。例如，

(a) Tissue and cells used as starting materials for medicinal products:…
用作药品起始物料的组织和细胞：......

In the following. Illustrative guide to manufacturing activities within the scope of Annex 2 and sections, all ATMP relevant parts and wordings were eliminated - for example:

如下所述，该修订版对附录2的范围和章节，取消了所有ATMP相关部分和措辞 - 例如：

Animals:

动物

Current version:

现行版

19 (b) Animal tissues and cells derived post-mortem and from establishments such as abattoirs: examples include xenogeneic cells from animal tissues and cells, feeder cells to support the growth of some ATMPs, abattoir sources for enzymes, anticoagulants and hormones (sheep and pigs).

来自死后尸体或处理机构（如屠宰场）的动物组织和细胞：例如，来自动物组织和细胞的异种细胞，支持一些ATMP生长的饲养细胞，来自屠宰场的酶、抗凝血剂和激素（羊和猪)。

Revision:

修订版

19 (b) Animal materials derived post-mortem and from establishments such as abattoirs: examples include abattoir sources for enzymes, anticoagulants and hormones (sheep and pigs).

来自死后尸体或处理机构（如屠宰场）的动物组织和细胞的动物材料：例如，来自屠宰场的酶、抗凝血剂和激素（羊和猪)。

Production:

生产

Current version:

现行版

30. For cell based ATMPs where production batches are frequently small the risk of cross-contamination between cell preparations from different donors with various health status should be controlled under defined procedures and requirements.

对于基于细胞的ATMP，当生产批量经常小时，来自各种健康状态的不同捐赠者的细胞制备之间的交叉污染风险，应当按照清楚规定的规程和要求进行的控制。

Revision:

修订版

30. For medicinal products from cells and tissues where production batches are frequently small the risk of cross-contamination between cell preparations from different donors with various health status should be controlled under defined procedures and requirements.

对于生产批量通常较小的细胞和组织的药品，来自不同健康状态的不同供体的细胞制备之间的交叉污染风险，应当按照清楚规定的规程和要求进行的控制。

In the chapter of Starting and raw materials, the part about donation, procurement and testing of cells and tissues was enlarged:
Current version:

在起始和原材料一章中，扩展了有关细胞和组织的捐赠，采购和检验的部分内容。

Current version:

现行版

36. For human tissues and cells used as starting materials for biological medicinal Product:

对于作为生物药品起始物料的人体组织与细胞：

Revision:

修订版

36. The donation, procurement and testing of human tissues and cells used as starting or raw materials should be in accordance with Directive 2004/23/EC.18 360 Traceability for human tissues and cells used as starting materials for biological medicinal products should be maintained from the donor to the batch of a finished medicinal product. Appropriate arrangements should be made between the manufacturer and the supplier of tissues and cells regarding the transfer of health donor information that may become available after the supply of the starting material and which may have an impact on the quality or safety of the medicinal product manufactured therefrom.

用作起始原料或原料的人体组织和细胞的捐赠，采购和检验应符合指令2004/23 / EC.18.33保持用作生物医药产品原料的人体组织和细胞从供体到药物成品批次的可追溯性。关于在提供原料后可能获得的健康供体信息的传递，以及可能对医药产品的质量或安全性产生影响的信息的传递，制造商和组织和细胞供应商之间应做出适当的安排 。

The section 44. of the chapter Seed lot and cell bank system was completely deleted:

章节：种子批和细胞库系统第44条被完全删除：

Current Version:

现行版

"Cell based medicinal products are often generated from a cell stock obtained from limited number of passages. In contrast with the two tiered system of Master and Working cell banks, the number of production runs from a cell stock is limited by the number of aliquots obtained after expansion and does not cover the entire life cycle of the product. Cell stock changes should be covered by a validation protocol.”

基于细胞的药品通常从有限传代次数的细胞储存库中获得。与主细胞库与工作细胞库的两级系统相比，来自细胞储存库中的生产运行数量受到在表达后所得的等分数量的限制，并且未覆盖整个产品生命周期。应当有验证方案涵盖细胞储存库的变更。

Revision:

修订版

- no section 44. –

没有第44条

An example for the update of relevant guidelines which will be referenced in the Annex 2 revision will be section 23 in the chapter Animals:

在章节：动物第23条更新了参考指南：

Current version:

现行版
Note should be taken of Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes as regards requirements for animal quarters, care and quarantine. Housing for animals used in production and control of biological active substances and medicinal products should be separated from production and control areas.

关于动物饲养场所、照料以及检疫要求，应当注意欧盟理事会第86/609/EEC号法令，该法令是关于保护试验和其他科学目的用动物成员国法律、法规和管理规定的近似法规。用于生物原料药和生物制剂生产以及质量控制的动物的饲养房应当与生产以及质量控制区域相隔离。

Revision:

修订版

Note should be taken of Directive 2010/63/EU on the protection of animals used for scientific purposes . Housing for animals used in production and control of biological active substances and medicinal products should be separated from production and control areas.

应注意关于保护用于科学目的的动物的指令2010/63 / EU。用于生物活性物质和医药制剂生产和控制的的动物房应与生产和控制区域相隔离。

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