供应商资质认证

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01.03.2017

What are the current Rules for Supplier Qualification?

供应商资质认证的现行规定是什么？

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. It should provide an appropriate level of confidence that suppliers, vendors and contractors are able to supply consistent quality of materials, components and services in compliance with regulatory requirements. An integrated supplier qualification process should also identify and mitigate the associated risks of materials, components and services. But what are the exact requirements?

供应商资质认证不只是审计。供应商资质认证可以被看作是风险评估的工具。供应商资质认证应提供一个置信水平，即供应商，分销商和承包商能够提供符合法规质量要求的物料、成分以及服务。一个完整的供应商资质认证程序也应确认并减轻物料，成分以及服务的相关风险。但是，准确的要求是什么呢？

They are wide-ranging and complex. There are different directives and regulations for medicinal drug products for human or veterinary use and for investigational medicinal drug products. Certain requirements in different directives and the EU-GMP Guidelines define expectations. Here are some examples:

这些要求范围广且复杂。关于人或动物使用的医药品，以及临床医药品有不同的指令和法规。在不同指令中的具体要求和EU-GMP指南规定了期望的内容。这有一些例子：

Article 8 of EU-Directive 2001/83/EC

"The application [of a marketing authorization] shall be accompanied […] by […] a written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of active substance with principles and guidelines of good manufacturing practice by conducting audits."

EU-指令第八条 2001/83/EC

申请【一个市场销售的申请】应带有一个书面的确认，即通过审计，药品生产商被确认符合原料药制造商的原则和GMP指南的。

Article 46 of EU-Directive 2001/83/EC

"The holder of a manufacturing and/or import authorisation shall at least be obliged […] to use only active substances, which have been manufactured in accordance with GMP for active substances and distributed in accordance with GDP for active substances and … to ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate GMP is."

EU-指令第46条 2001/83/EC

生产持有者或进口许可应该至少有义只使用依照原料药GMP生产的，并且依照原料药GDP销售的原料药，，通过正确的GMP以确保辅料适合用于药品中. Article 46b of EU-Directive 2001/83/EC

"Active substances shall only be imported if they have been manufactured in

accordance with standards of good manufacturing practice at least equivalent to those laid down by the European Union". This can be shown by a written confirmation or the exporting country is included in the so called white list or a waiver has been granted.

EU-指令第46条b 2001/83/EC

如果原料药依照GMP标准（至少EU提出的同等的要求）生产的，可被进口。这可以由一个书面的确认表明，并且出口过应包括在所谓的白名单中或弃权。EU-GMP Guidelines Chapter 5 (Production):

EU-GMP指南第五章（生产）

5.27 "The selection, qualification, approval and maintenance of suppliers of starting materials, together with their purchase and acceptance, should be documented as part of the pharmaceutical quality system..."

5.27 起始物料供应商的选择、资质认证、批准和维护，以及起始物料的采购和接收，应该作为药物的质量系统的一部分记录在案。

5.29 "Audits should be carried out at the manufacturers and distributors of active substances to confirm that they comply with the relevant good manufacturing practice and good distribution practice requirements. (…) Audits should be of an appropriate duration and scope to ensure that a full and clear assessment of GMP is made; (…). The [audit] report should fully reflect what was done and seen on the audit with any deficiencies clearly identified. Any required corrective and preventive actions should be implemented. Further audits should be undertaken at intervals defined by the quality risk management process to ensure the maintenance of standards and continued use of the approved supply chain."

5.29 应对原料药的制造商和分销商进行审计，已确认他们符合相关的GMP和GDP的要求。审计应该具有一个恰当的期限、范围，确保做出全面清楚的GMP 评估。审计报告应全面反应在审计中所做和所见到的，以及确认的缺陷。要求的整改措施应该被执行。质量风险管理程序在指定的时间间隔内应进行进一步的审计，确保标准维护和批准的供应链的持续使用。

5.45 "The selection, qualification, approval and maintenance of suppliers of primary and printed packaging materials shall be accorded attention similar to that given to starting materials."

5.45对于外包装材料和印刷的包装材料的供应商的选择、资质认证、批准和维护应与起始物料的供应商一致。

Chapter 7 of the EU-GMP Guidelines(Outsourced Activities) describes the responsibilities of the Contract Giver when it comes to contract manufacturing and testing. He needs to assure the control of the outsourced activities, incorporating quality risk management principles and including continuous reviews of the quality of the Contract Acceptor's performance. Audits are helpful tool to asses the "legality, suitability and the competence of the Contract Acceptor". The new Chapter 7 was obviously designed to intensify the control of Contract Acceptors by the Contract Giver and extend those controls to subcontractors.

当谈到外包生产和检验时，EU-GMP指南第七章（外包活动）描述了合同授予人的责任。他需要保证外包活动的控制，结合质量风险管理原则，并且包括持续审核合同接受人表现的质量。审计是规范合同接受人的合法性、适用性和能力的