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WHO第957号技术报告附录5，早在2010年发布。因有人问，所以上传中英文供大家参考。感觉要求提的蛮高……
World Health Organization WHO Technical Report Series, No. 957, 2010 Annex 5 WHO good distributionpractices for pharmaceutical products 药品优良销售运输规范 | | | | | | | | 5. Regulation of the distribution of pharmaceutical products | | 6. Organization and management | | | | | | 9. Premises, warehousing and storage | | 10. Vehicles and equipment | | 11. Shipment containers and container labelling | | | | 13. Transportation and products in transit | | | | 15. Repackaging and relabelling | | | | | | | | 19. Counterfeit pharmaceutical products | | | | | | | | | |
1. Introduction 前言Distribution is an important activity in the integrated supply-chain managementof pharmaceutical products. Various people and entities are generallyresponsible for the handling, storage and distribution of such products. Insome cases, however, a person or entity is only involved in and responsible forcertain elements of the distribution process. The objective of these guidelinesis to assist in ensuring the quality and identity of pharmaceutical productsduring all aspects of the distribution process. These aspects include, but arenot limited to, procurement, purchasing, storage, distribution, transportation,repackaging, relabelling, documentation and record-keeping practices. 在药品完整的供应链管理中，销售运输是一个重要的环节。一般会由不同的个人和实体负责此类产品的搬运处置、存贮和销售运输。在有些情况下，一个人或实体只会参与和负责销售运输过程中特定的环节。本指南的目的是帮助确保在销售运输过程中所有各操作里药品的质量和鉴别。这些操作包括但不仅限于采购、购买、存贮、销售、运输、重新包装、重新贴标、文件记录和记录保存规范。 The storage, sale and distribution of pharmaceutical products are often carriedout by various companies, institutions and individuals. This document sets outappropriate steps to assist in fulfilling the responsibilities involved in thedifferent aspects of the distribution process within the supply chain and toavoid the introduction of counterfeits into the marketplace via thedistribution chain. The relevant sections should be considered by variousparticipants as applicable to the particular role that they play in the distributionof pharmaceutical products. 药品的存贮、销售和运输通常由不同公司、机构和个人实施。本文件建立了适当的步骤，以帮助履行供应链中销售运输过程的不同操作所涉及的职责，避免通过销售运输链给市场引入假药。相关各方应根据其在药品销售运输中所担当的角色考虑本指南的相关部分内容。 The nature of the risks involved is likely to be similar to that for risksencountered in the manufacturing environment, e.g. mix-ups, adulteration, contaminationand cross-contamination. When the distribution chain is interrupted bymanufacturing steps such as repackaging and relabelling, the principles of goodmanufacturing practices ( GMP) should be applied to these processes. 销售运输所涉及的风险的属性与生产环境中所遇到风险是类似的，例如，混药、掺假、污染和交叉污染。如果销售运输链被生产步骤打断，如重新包装和重新贴标，则优良生产规范（GMP）的原则适用于此过程。 Counterfeit pharmaceutical products are a real threat to public health andsafety. Consequently, it is essential to protect the pharmaceutical supplychain against the penetration of such products. Weak points in the distributionprocesses of pharmaceutical products provide an avenue for counterfeit as wellas illegally imported, stolen and substandard medicines to enter the supplychain. This is a concern in both developed and developing countries. Themethods by which such products enter the supply chain have become increasinglycomplex and have resulted in the development of thriving secondary and greymarkets throughout the world. 假药对于公众健康和安全构成威胁。因此，有必要保护药品供应链不会被此类产品渗透。药品销售运输过程中的弱点给假药发生和非法进口、盗窃和不达标药品进入供应链提供了机会。这在发达国家和发展中国家都是问题。此类产品进入供应链的方式日益复杂，已经导致了全球新兴二手和灰色市场的发展。 The involvement of unauthorized entities in the distribution and sale of pharmaceuticalproducts is a particular concern. Only a joint approach including all partiesinvolved in the supply chain can be successful in the fight against counterfeitpharmaceutical products and, therefore, all parties active in the market shouldtake an active part in collaborative activities. 尤其担心的是未经授权进入药品销售运输过程问题。只有供应链中所有各方联合起来，才可能成功狙击假药，因此，市场中活跃的各方均采取主动措施联合行动。 Different models for the distribution of pharmaceutical products are used indifferent countries and sometimes within the same country, for example, in thepublic and the private sector. These guidelines are intended to be applicableto all persons and outlets involved in any aspect of the distribution ofpharmaceutical products from the premises of the manufacturer of the product tothe person dispensing or providing pharmaceutical products directly to apatient or his or her agent. This includes all parties involved in trade anddistribution of medicines, pharmaceutical manufacturers, including the manufacturersof finished products and pharmaceutical wholesalers as well as other partiessuch as brokers, suppliers, distributors, logistics providers, traders,transport companies and forwarding agents and their employees. 在不同国家，有时在同一个国家会使用不同的药品销售运输模式，例如，在公共和私人领域。本指南意在适用于参与药品销售运输各环境的所有个人和出口，从药品生产商的设施到直接分发或提供药品给患者及其代理的人员。这包括了参与药品贸易和销售运输的所有各方，药品生产商，包括制剂生产商和药品批发商，以及其它各方如经销商、中间商、分销商、物流公司、贸易商、运输公司和货运代理及其雇员。 The relevant sections of these guidelines should also be considered for implementationby, among others, governments, regulatory bodies, international procurementorganizations, donor agencies and certifying bodies, as well as all partiesinvolved in any aspect of the trade and distribution of pharmaceuticalproducts, including health care workers. The guidelines can also be used as atool in the prevention of the distribution of counterfeit pharmaceuticalproducts. It should, however, be noted that these are general guidelines whichmay be adapted to suit the prevailing situations and conditions in individualcountries. National or regional guidelines may be developed to meet specificneeds and situations in a particular region or country. 本指南相关部分也应考虑由政府、法规主体机构、国际采购组织、捐助机构和认证主体，以及参与药品贸易和销售运输不同环节的各方，包括保健工作者，予以实施。本指南也可以用作一个工具，防止假药销售运输。应注意有一些是通用指南，可以适用在各国家的大部分情形和条件。国家或地区可以制订指南符合各国家或地区的特定需求和情形。 To maintain the original quality of pharmaceutical products, every party activein the distribution chain has to comply with the applicable legislation andregulations. Every activity in the distribution of pharmaceutical productsshould be carried out according to the principles of GMP, good storage practice(GSP) and good distribution practice (GDP) as applicable. 为了维护药品的原始质量，销售运输链活动各方必须符合适用的法律法规。药品销售运输过程中的每一种活动均应符合适用的GMP原则、优良存贮规范（GSP）和优良销售运输规范（GDP）。 These guidelines do not deal with all aspects of the standards for thestorage of pharmaceuticals which are covered in the WHO guide to goodstorage practices for pharmaceuticals (1). The dispensing topatients is addressed in the WHO good pharmacy practice (GPP) guide (2).These guidelines should also be read in conjunction with other WHO guidelines (3–6). 本指南不包括药品存贮的标准方面的问题，该问题包括在WHO“药品优良存贮规范”中。向患者分发的问题包括在WHO“优良药房规范（GPP）指南”中。本指南还应与其它WHO指南联合解读。
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