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SCHEDULE FORDRAFT WORKING DOCUMENT QAS/19.793:

GOOD STORAGE AND DISTRIBUTIONPRACTICES

优良贮运规范

GOOD STORAGE AND DISTRIBUTION PRACTICES

优良贮运规范

1.   INTRODUCTION 前言

1.1.   Storage and distribution are important activitiesin the supply chain management of medical products. Various people and entities are generally responsible for handling, storage and distribution. Products may be subjected to various risks at different stages inthe supply chain, i.e. during purchasing, storage, distribution, transportation, repackaging, and relabelling.Further, substandard and falsified products are a real threat to public health and safety. Consequently, it is essential to protect the supply chain against the penetration of such products.

存贮和运输是药品供应链管理中的重要活动。搬运、存贮和运输一般是由不同人员和实体来负责的。药品在供应链（即购买、存贮、分发、运输、包装与重新贴标）的不同阶段可能会经历不同的风险。另外，劣质与假药对于公司健康和安全来说是一种现实的威胁，因此有必要保护供应链不被此类渗入。

1.2.  This document sets out appropriate steps to assist in fulfilling the responsibilities involved in the different stages within the supply chain and to avoid the introduction of substandard and falsified products into the market. The relevant sections should be considered as particular roles that entities play in the storage and distribution of medical products.

本文件设立了一些适当的措施来协助满足供应链不同阶段中涉及的责任，避免将劣药和假药引入市场。相关部分应看作是实体在药品贮运过程中所担当的特殊身份。

1.3. This guideline is intended to be applicable to all persons and outlets involved in any aspect of the storageand distribution of medical products from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to apatient or his or her agent.  This includes all parties involved in trade, storage and distribution of medical products, manufacturers and wholesalers, as well as other parties such as brokers, suppliers,distributors, logistics providers, traders, transport companies and forwarding agentsand their employees.

本指南意在适用于药品从生产商场所到直接向患者或其代表人分发或提供药品的人员的整个贮运过程中涉及的所有人员和出口。这其中包括了药品贸易、存贮和运输过程中所有参与方、生产商和批发商以及其它各方如代理、供应商、分销商、物流服务方、贸易商、运输公司和货代以及其雇员。

1.4. The relevant sections of  this guideline should also be considered for implementation by,amongst others, governments, regulatory bodies, international procurement organizations,donor agencies and certifying bodies, as well asall parties involved in any aspect of the trade and distribution of pharmaceutical products, including health care workers.

政府部门、药监机构、国际采购组织、捐赠机构和认证机构以及药品贸易和分销所有方面涉及的各方，包括卫生工作人员均应考虑实施本指南的相关部分。

1.5.  The guidelines can also be used as a tool in the prevention of the distribution of substandard  and falsified  products. It should, however, be noted that these  are general guidelines which may be adapted to suit the prevailing situations and conditions inindividual countries. National or regional guidelines may be developed to meet specific needs and situationsin a particular region or country.

本指南亦可用于防止劣药与假药销售。但需要注意这只是通用的指南，可用于常见情形亦可用于单个国家。可制订国家或地区指南以满足特定国家或地区的特定需求和情形。

1.6.   To maintain the original quality of medical products, every party active in the supply chain has to comply with the applicable legislation and regulations. Every activity in the storage and distribution of medical products should be carried out according to the principles of good manufacturing practices (GMP), good storage practice (GSP) and good distribution practice (GDP) as applicable.

为维护药品的原始质量，供应链的参与各方必须符合适用的法律法规。药品贮运过程中的每个活动均应根据适用的GMP、GSP和GDP的要求执行。

1.7.    This guideline does not deal with dispensing to patients as this is addressed in the World Health Organization (WHO) good pharmacy practice (GPP) guide (xx). These guidelines should also be read in conjunction with other WHO guidelines (xx).

本指南并不涉及向患者分发药品的阶段，因为此部分在WHO的GPP指南中。本指南亦应与WHO的其它指南一起解读。

2.     SCOPE 范围

2.1.  This document lays down guidelines for the storageand distribution of medical products. It is closely linked to other existing guidelines recommended by the WHO Expert Committee on Specifications for Pharmaceutical Preparations, such as referenced in section (xyz).

本文件给出的是药品贮运指南。它与现有WHO药品质量标准专家委员会建议的其它指南紧密相关，例如在XYZ部分所引用的内容。

2.2. Depending on the national and regional legislation, these guidelines may apply equally to products for human and for veterinary use. The guidelines thus cover products for which a prescription is required by the patient, products which may be provided to a patient without a prescription, biologicals, vaccines and medical devices.

由于国家和地区法律不同，本指南可能等同适用于人药与兽药。本指南覆盖处方药、非处方药、生物制品、疫苗和医疗器械。

2.3.  The document does not specifically cover GMP aspects of finished products in bulk, distribution of labels or packaging as these aspects are considered to be covered by other guidelines. The principles for the distribution of starting materials (active pharmaceutical ingredients (APIs) and excipients) are also not covered here.These are laid down in the WHO guidance “Good Trade and Distribution Practices for Pharmaceutical Starting Materials”(7).

本文件并未特别包括散装药品的GMP问题、分销与贴标或重新包装，因为这些方面包括在其它指南中。起始物料的分销原则（API和辅料）亦未包括在其中，这些内容包括在WHO指南“药品起始物料优良贸易与分销规范”中。