DST：对于EU GMP 取样关于逐件物料取样鉴别对于企业来说成本较高，且不易管控，那么实际执行过程中如何进行控制才能满足对于物料的取样要求：

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelinesChapter 5 - Production

EudraLex-第4卷-良好生产规范（GMP）指南第5章-生产

5.35 Manufacturers of finished products are responsible for any testing of starting materials2 as described in the marketing authorisation dossier. They can utilise partial or full test results from the approved starting material manufacturer but must, as a minimum, perform identification testing3 of each batch according to Annex 8.

5.35成品制造商负责对上市许可档案中描述的起始物料进行任何测试。他们可以利用经批准的起始物料制造商的部分或全部测试结果，但至少必须根据附录8对每批进行鉴定测试。

EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines

ANNEX 8 SAMPLING OF STARTING AND PACKAGING MATERIALS

EudraLex-第4卷-良好生产规范（GMP）指南

附录8起始物料和包装材料的抽样

Starting materials 起始物料

2.The identity of a complete batch of starting materials can normally only be ensured if individual samples are taken from all the containers and an identity test performed on each sample. It is permissible to sample only a proportion of the containers where a validated procedure has been established to ensure that no single container of starting material has been incorrectly labelled.

通常，只有从所有容器中采集单个样品并对每个样品进行身份测试，才能确保完整批次起始物料的身份。允许仅对已建立有验证程序的一部分容器进行取样，以确保没有单个容器的起始物料标签错误。

DST：这里提到了验证程序，难道物料供应商也需要验证？我们看看该验证有什么要求：

3.This validation should take account of at least the following aspects: 该验证应至少考虑以下方面：

— the nature and status of the manufacturer and of the supplier and their understanding of the GMP requirements of the Pharmaceutical Industry;

制造商和供应商的性质和地位，以及他们对制药行业GMP要求的理解；

— the Quality Assurance system of the manufacturer of the starting material;起始物料制造商的质量保证体系；

— the manufacturing conditions under which the starting material is produced and controlled;生产和控制起始物料的制造条件；

— the nature of the starting material and the medicinal products in which it will be used.起始物料的性质及其将要使用的医药产品的性质。

Under such a system, it is possible that a validated procedure exempting identity testing of each incoming container of starting material could be accepted for:在这样的系统下，可以接受一个经过验证的程序，免除每个原料容器的身份测试，用于：

— starting materials coming from a single product manufacturer or plant; 来自单一产品制造商或工厂的起始物料；

— starting materials coming directly from a manufacturer or in the manufacturer’s sealed container where there is a history of reliability and regular audits of the manufacturer’s Quality Assurance system are conducted by the purchaser (the manufacturer of the medicinal product) or by an officially accredited body.直接来自制造商的起始物料或制造商具有可靠性历史的密封容器，由买方（药品制造商）或官方认可机构对制造商的质量保证体系进行定期审计。

It is improbable that a procedure could be satisfactorily validated for:程序不太可能在以下方面得到令人满意的验证：

— starting materials supplied by intermediaries such as brokers where the source of manufacture is unknown or not audited;由中间人（如经纪人）提供的起始物料，其制造来源未知或未经审计

— starting materials for use in parenteral products.用于注射产品的起始物料。

针对以上内容可总结出根据EudraLex第4卷关于GMP的指南，对于起始物料的取样和鉴别有以下要求：

1.对于每个原料容器的内容物，应制定适当的程序或措施，以确保其身份。从散装容器中取样后，应予以标识。

2.成品制造商负责对起始物料进行测试，可以利用批准的起始物料制造商的部分或全部测试结果，但至少必须对每批进行鉴定测试。

3.针对起始物料的取样程序应经过验证，验证应考虑制造商和供应商的性质和地位、质量保证体系、生产条件，以及起始物料的性质和将要使用的药品产品的性质。

4.对于来自单一产品制造商或工厂的起始物料，或来自制造商直接提供并具有可靠性历史的起始物料，可以通过验证程序免除每个原料容器的身份测试。

5.对于由经纪人提供的起始物料或用于注射产品的起始物料，程序不太可能得到令人满意的验证。

DST：除注射剂的起始物料外，我们是可以通过附录8提供的验证程序对自己的起始物料供应商制定不同的取样策略，如果供应商满足该验证程序要求则可不必进行逐件取样。