关于附录19的Reference sample和Retention sample

davidcone

我做了一个摘要。因为有客户问过我这个问题。
我的理解是从这个附录上来看，实际上我们企业现在做的留样已经涵盖了Reference sample和Retention sample这两个定义要求的内容，因此不必单独再去留出所谓的对照样品。请大家提意见。

EU GMP ANNEX 19 摘要
定义：
Reference sample: a sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned. Where stability permits, reference samples from critical intermediate stages (e.g. those requiring analytical testing and release) or intermediates, that are transported outside of the manufacturer’s control, should be kept.
对照样品: 一个批的起始原料、包装材料或成品的样品，用于相关批有效期内可能需要进行测试而保存的样品。如果稳定性允许，可以从重要的中间体生产阶段抽取对照样品，转移至生产商控制之外的中间体也应保留对照样品。

Retention sample: a sample of a fully packaged unit from a batch of finished product. It is stored for identification purposes. For example, presentation, packaging, labelling, patient information leaflet, batch number, expiry date should the need arise during the shelf life of the batch concerned. There may be exceptional circumstances where this requirement can be met without retention of duplicate samples e.g. where small amounts of a batch are packaged for different markets or in the production of very expensive medicinal products.
留样：从一批成品中抽取的完整包装的样品，供各种鉴别用。如有效期内因故需要时，可用于产品的演示，鉴别包装、贴签、产品性状特征/供病人用的说明书、批号、有效期等。

For finished products, in many instances the reference and retention samples will be presented identically, i.e. as fully packaged units. In such circumstances, reference and retention samples may be regarded as interchangeable.
对成品而言，很多情况下，对照样品和留样应相同，即取完整的包装单元。此条件下，两种样品可互换。

Reference and retention samples from each batch of finished product should be retained for at least one year after the expiry date. The reference sample should be contained in its finished primary packaging or in packaging composed of the same material as the primary container in which the product is marketed (for veterinary medicinal products other than immunologicals, see also Annex 4, paragraphs 8 & 9).
每批成品的对照样品和留样应至少保留至有效期后一年。对照样品的包装材料和上市成品的包装材料应一致。

Unless a longer period is required under the law of the Member State of manufacture, samples of starting materials (other than solvents, gases or water used in the manufacturing process) shall be retained for at least two years after the release of product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter. Packaging materials should be retained for the duration of the shelf life of the finished product concerned.
如果没有特殊的法律要求，起始原料的样品应保留至少产品放行后两年。包装材料的留样时间与成品相同。

tsingsea

学习了，会英语的都是大师

靓妹

我的看法和楼主一致。我们的留样已包括楼主摘要中的两种功用。

一沙一叶

同意楼主的说法。

newfellow

我估计客户怀疑,你的样品 + 其他需要的全检 够不够. 比如说有投诉 + 稳定性,可能就不够了.

药视小秘书

谁有附录19