WHO TRS 1025

Annex 8 附录8
Points to consider for setting the remaining shelf-life of medical products upon delivery
设定医用产品送达时剩余货架期的考量要点
1. Introduction 概述
2. Scope 范围
3. Glossary 术语
4. The need for recommendations 建议需求
5. Remaining shelf-life 剩余货架期
References 参考文献
Further reading 扩展阅读
Appendix1 Example of minimum remaining shelf-life of medical products
附录1 医用产品最短剩余货架期举例

1. Introduction 概述
Following discussions relating to establishing a document for the remaining shelf- life of medical products upon delivery, and considering the discussion between the Interagency Pharmaceutical Coordination group (IPC) representatives, it was decided to initiate a project to establish a document on remaining shelf-life for procurement and supply of medical products.
在讨论了为药品送达时剩余货架期制订一份文件，并考虑了机构间药品合作组（IPC）代表之间的讨论后，我们决定启动一个项目，制订一份关于医用产品采购和供应中剩余货架期的文件。
The concept and project to establish such a document was also discussed during the meeting of the Fifty-third Expert Committee on Specifications for Pharmaceutical Products (ECSPP) in October 2018. It was noted that some guidance documents were available from different procurement agencies. It was agreed that the World Health Organization (WHO) would initiate the discussion and preparation of a document, while following the WHO process for the establishment of such a paper.
在2018年10月药品专家委员会（ECSPP）第53次会议中，也讨论了制订这样一份文件的概念和项目。我们注意到不同采购机构有一些指南文件。在执行了WHO起草此类报告的程序之后，我们一致同意WHO应开始讨论并起草一份文件。
Information and policy on remaining shelf-life was collected from different agencies and interested parties and a first draft document was prepared after an informal discussion meeting in Geneva, Switzerland, in January 2019.
我们从不同机构和有关当事方采集了关于剩余货架期的信息和政策，并在2019年1月瑞士日内瓦的正式讨论会议之后起始了第一份草案。
It was then agreed that the document should not cover only finished pharmaceutical products but should be extended to also cover other products, including, but not limited to, medical devices, vaccines and in vitro diagnostics (IVD) products. (These products are collectively referred to as “medical products” hereafter.)
然后我们认为该文件应不仅仅包括制剂药品，还应扩展至其它产品，包括但不仅限于医疗器械、疫苗和体外诊断试剂（IVD）产品。（下文中这些产品统一称为“医用产品”）
A draft document was prepared and circulated to IPC members, as well as other interested parties, inviting comments. The comments received were reviewed during an informal discussion meeting in June 2019 and the draft document was updated.
草案起草之后交IPC成员和其它有关当事方传阅以征求意见。在2019年6月的正式讨论会议中，我们对所收到的建议进行审核，更新了草案。
The aims of this document are: 本文件目的在于：
■ to facilitate the national authorization of importation of medical products where applicable;
■ 便于国家批准医用产品进口（适用时）；
■ to promote and support the efficient processing of medical products in the supply chain at all levels and thus prevent wastage because of delays;
■ 促进和支持供应链中医用产品在各层次的高效处理，从而防止因延误引起的浪费；
■ to assist in ensuring that there is sufficient stock of medical products, with acceptable remaining shelf life,in-country;
■ 有助于确保在国家内具备足够数据在可接受剩余货架期的医用产品库存；
■ to prevent dumping of medical products;
■ 防止医用产品倾销；
■ to ensure that barriers to access and supply of medical products are addressed;
■ 确保解决医用产品获取和供应障碍；
■ to prevent out-of-stock situations;
■ 预防库存不足；
■ to prevent receipt of donations of medical products that are not in accordance with this guideline; and
■ 预防不按本指南接收捐献医用产品，并且
■ to prevent having expired stock of medical products.
■ 预防库存医用产品过期。
The document is intended to provide guidance on setting the remaining shelf-life ofmedical products upon delivery and should be considered by all stakeholders in the supply chain of medical products. It is also recommended that the recommendations herein should be considered for inclusion in the national policy of countries.
本文旨在提供送达时药品剩余货架期的设置指南，药品供应链中所有干系人均应考虑本文件指南。亦建议同时考虑国家政策要求。
2. Scope 范围
The principles contained in this document should be applied to medical products in the supply chain. This includes donated products (1).
本文件中所含原则应用于供应链中的医用产品，包括捐献的医用产品。
This document focuses on remaining shelf-life and does not address details contained in other guidelines, guides and agreements between different parties in the supply chain.
本文件侧重于剩余货架期，不会解释其它指南和供应链中各方协定中已有的细节。
As “kits” are made up of different products, and owing to certain specifics related to the shelf-life of kits, these are not included in the scope of this guideline. The principles contained in this guideline may, however, be used in considering the remaining shelf-life of items in a kit, as the expiry date of the kit can be short because of aspecific product in the kit.
由于“试剂盒”是由不同产品组成，属于试剂盒货架期相关的具体规定，因此不在本指南范围内。当然，可使用本指南中所含原则考量试剂盒部件的剩余货架期，因为试剂盒可能因其中特定产品有效期短而导致整个试剂盒有效期较短。
All stakeholders, including national regulatory authorities, manufacturers, suppliers, donors and recipients, should consider the recommendations on remaining shelf-life contained in this document.
所有干系人，包括国家药监当局、生产商、供应商、捐献者和接收方，均应考虑本文件中的剩余货架期建议。
3. Glossary 术语
The definitions given below are taken from existing WHO guidelines, where available, or alternatively from other recognized guidelines.
以下定义采自现有WHO指南（如有），或来自其它公认的指南。
batch.批
A defined quantity of starting material, packaging material or product, processedin a single process or series of processes, so that it is expected to be homogeneous. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. The batch size can be defined either as a fixed quantityor as the amount produced in a fixed time interval.
经过了单一工艺或一系列工艺的处理，因此预期为均一的指定数量的起始物料、包装或产品。有时可能需要将一个批次拆分为数个子批，然后放在一起形成一个最终均一的批次。如果是终端灭菌产品，则批量应由灭菌器的容量决定。如果是连续生产，则批次必须对应指定的生产部分，其应具有均一性。批量可规定为一个固定的数量，亦可规定为在固定时间间隔内生产的数量。
consignment (or delivery). 所送货物（或发运的货物）
The quantity of a medical product(s), made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may compriseone or more packages or containers and may include material belonging to morethan one batch.
由一个生产商生产，按一个特定的要求或订单准备一次发运的一定数量的医用产品。一个运送货物可能含有一个或多个包装或容器，可包括不止一个批次的物料。
expiry date (or expiration date). 有效期
The date placed on the container or labels of a medical product designating the time during which it is expected to remain within established shelf-life specifications if stored under defined conditions, and after which it should not be used.
在医用产品容器或标签标识的日期，如果按指定条件存贮，则在该时间内药品预期能保持其既定的货架期质量标准，在该日期之后则不得使用。
finished pharmaceutical product (FPP). 制剂产品（FPP）
A product that has undergone all stages of production, including packaging in its final container and labelling. An FPP may contain one or more active pharmaceutical ingredients.
完成了所有生产步骤的产品，包括包装在其最终容器中和标签。一种FPP可包括一种或多种活性药物成分。
install by date. 最迟安装日期
The date by which an instrument, device or other has to be installed.
一台仪器、装置或其它必须安装的最迟日期。
manufacture.制造
All operations of purchase of materials and products, production, quality control, release, storage and distribution of medical products, and the related controls.
物料和产品的采购、医用产品生产、质量控制、放行、存贮和运输，以及相关控制等全部操作。
manufacturer.生产商
A company that carries out operations such as production, packaging, repackaging, labelling and relabelling of medical products.
执行医用产品操作如生产、包装、重新包装、标签和重新标签的公司。
marketing authorization (product licence, registration certificate).上市许可（产品许可、注册证）
A legal document issued by the competent medicines regulatory authority that establishes the detailed composition and formulation of the product and the pharmacopoeial or other recognized specifications of its ingredients and of the final product itself, and includes details of packaging, labelling and shelf-life.
由药监当局签发的一份法定文件，规定了该产品的详细组成和配方，以及其成分和最终产品本身的药典或其它认可标准，并且包括了包装、标签和货架期的详细信息。
manufacturer (IVD). 生产商（IVD）
Any natural or legal person with responsibility for design and/or manufacture of an IVD product with the intention of making it available for use, under his or her name, whether or not such an IVD product is designed and/or manufactured by that person him- or herself or on his or her behalf by (an) other person(s).
具有IVD产品设计和/或生产职责，意在使该产品以其名可供使用的所有自然人或法人，无论该IVD产品是否由该人自己或代表其它人设计和/或生产。
manufacturing date. 生产日期
The date of production of a batch is defined as the date that the first step is performed involving combination of the active ingredient with other ingredients. Where there are no other ingredients than an active ingredient, the date of the start of the processing or filling operation is considered as the date of production.
一个批次的生产日期定义为活性成分与其它成分组合的第一步实施的日期。如果除了活性成分以外没有其它成分，则加工或灌装操作的开始日期则为生产日期。
medical product. 医用产品
Products including, but not limited to, finished pharmaceutical products, medical devices, vaccines and IVD products.
医用产品包括但不仅限于制剂、医疗器械、疫苗和IVD产品。
pharmaceutical product. 药品
Any material or product intended for human or veterinary use presented in its finished dosage form, or as a starting material for use in such a dosage form, that is subject to control by pharmaceutical legislation in the exporting state and/or the importing state.
在出口国和/或进口国的药品法中受到控制，以制剂形式、或作为此类制剂用起始物料形式出现的人用或兽用的所有物料或产品。
production.生产
All operations involved in the preparation of a product, from receipt of materials, through processing, packaging and repackaging, labelling and relabelling, to completion of the finished product.
药品制备过程中涉及的所有操作，从物料接收，到加工、包装和包装、标签和重新标签，至制剂完成。
remaining shelf-life. 剩余货架期
Definedas the period remaining, from the date upon delivery, to the expiry date, retest date, install by date or other use before date established by the manufacturer.
从送达期起计，到生产商订立的有效期、复验期、最迟安装日期或其它最迟使用日期的剩余时间段。
retest date. 复验期
The date when a material should be re-examined to ensure that it is still suitable for use.
物料需要重新检查以确保其仍适合其用途的日期。
shelf-life.货架期
The period of time, from the date of manufacture, that a product is expected to remain within its approved product specification while handled and stored under defined conditions.
从生产日期开始，按指定条件处置和存贮时，产品预期能够保持其所批准的产品质量标准的时间段。
upon delivery. 送达时间
The date the medical product is delivered as specified, e.g. at the port, at the point in country after customs clearance, or at the end-user – and as defined in the agreement between relevant parties.
医用产品按指定要求送达日期，例如，在港口、在清关后国家某点，或在终端用户处，以及相关方协定的地点。

【译文仅供参考 翻译：JULIA】

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WHO_TRS_1025 2020 附录8 设定药品送达时剩余货架期的考量要点.rar