EUGMP—附录8原辅包装材料的取样（更新日期20161220）

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ANNEX 8   附录8                                               

SAMPLING OF STARTING AND PACKAGINGMATERIALS

原辅包装材料的取样

Principle

原则

Sampling is animportant operation in which only a small fraction of a batch is taken. Valid conclusionson the whole cannot be based on tests which have been carried out onnonrepresentative samples. Correct sampling is thus an essential part of asystem of Quality
Assurance.

取样是一项重要操作，每次取样只能是批的一小部分。样品如无代表性，则根据样品检验的结果无法得出正确的结论。因此，正确取样是质量保证体系的基本要素。

Note

注意

Sampling is dealt with in Chapter 6 of the Guide, items 6.11. to6.14. This annex gives
additional guidance on the sampling of starting and packaging materials.

在GMP指南第六章6．11-6．14小节介绍了取样操作。本附录是对原辅包装材料取样的补充说明。

Personnel

人员

1. Personnel who take samples should receive initial and on-goingregular training in the disciplines relevant to correct sampling. This trainingshould include:

取样人员应该接受科学正确取样的初始培训和定期继续培训，培训应包括以下内容：

— sampling plans,

取样计划；

— written sampling procedures,

  书面的取样程序；

— the techniques and equipment for sampling,

  取样技术和设备；

— the risks of cross-contamination,

    交叉污染的风险；

— the precautions to be taken with regard to unstable and/orsterile substances,

  不稳定和/或无菌原辅料取样应采取的预防措施；

— the importance of considering the visual appearance ofmaterials, containers and labels,

  对物料、容器和标签进行外观检查的重要性；

— the importance of recording any unexpected or unusualcircumstances.

  对意外情况或异常情况做好记录的重要性。

Starting materials

原辅材料

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

只有对每一个包装容器中的样品都进行鉴别试验后，才能确认整批物料的鉴别正确无误。只有通过验证建立了规程，能确保原辅材料的每一个包装的贴签不可能出现差错时，才允许对批的一部分容器进行取样。

3. This validation should take account of at least the followingaspects:

验证应当至少考虑一下几方面：

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

—生产商和供应商的身份和种类，以及他们对制药企业GMP要求的了解程度；

— the Quality Assurance system of the manufacturer of the startingmaterial;

—原辅材料生产商的质量保证体系；

— the manufacturing conditions under which the starting materialis produced and controlled;

—原辅材料的制造条件是生产和质量控制；

— the nature of the starting material and the medicinal productsin which it will be used.

—原辅材料的性质以及采用这些原辅材料的药品的性质。

Under such a system, it is possible that a validated procedureexempting identity testing of each incoming container of starting materialcould be accepted for:

在以下系统中，才可能采用经验证而不要求对批的每一个容器抽样进行鉴别的规程：

— starting materials coming from a single product manufacturer or plant;

—当原辅材料只来自某一个生产商或车间时；

— starting materials coming directly from a manufacturer or in themanufacturer’s sealed container where there is a history of reliability andregular audits of the manufacturer’s Quality Assurance system are conducted bythe purchaser (the manufacturer of the medicinal product) or by an officiallyaccredited body.

—购货单位对供货商的质量保证系统定期进行审计，或由官方认可的第三方进行审计，供货商有可靠的历史，当原辅料直接来自这些生产商，或由他们以密封容器供货。

It is improbable that a procedure could be satisfactorilyvalidated for:

采用下列程序不可能得到满意的验证结果：

— starting materials supplied by intermediaries such as brokerswhere the source of manufacture is unknown or not audited;

—原辅材料是由中间商如经纪人供货，生产源头不详或未经审计；

— starting materials for use in parenteral products.

—用于生产注射类药品的原辅材料。

4. The quality of a batch of starting materials may be assessed bytaking and testing a representative sample. The samples taken for identitytesting could be used for this purpose. The number of samples taken for thepreparation of a representative sample should be determined statistically andspecified in a sampling plan. The number of individual samples which may beblended to form a composite sample should also be defined, taking into accountthe nature of the material, knowledge of the supplier and the homogeneity ofthe composite sample.

某一批原辅材料的质量，可通过抽取有代表性的样品和检验进行评估，如取样作鉴别试验，可用于批质量的评估。要通过统计学的计算来决定代表性样品的取样数，并在取样计划中做出规定。应考虑到原辅材料的性质、对供应商了解的程度以及混合样品的均一性，规定应由多少独立的样品混合制备得到一份混合样品。

Packaging material

包装材料

5. The sampling plan for packaging materials should take accountof at least the following:

包装材料的取样计划至少应考虑以下几个方面：

the quantity received, the quality required, the nature of thematerial (e.g. primary packaging materials and/or printed packaging materials),the production methods, and what is known of the Quality Assurance system ofthe packaging materials manufacturer based on audits. The number of samplestaken should be determined statistically and specified in a sampling plan.

收料量，所需数量，物料的属性，(如，内包材料和／或印制包装材料)，生产方法，以及通过质量审查所获得的内包装材料制造商质量保证体系的信息。取样量要通过统计学计算来决定并在取样计划中做出规定。

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