GMP供应商审计.pptVIP

供应商审计 * 供应商审计 * 药品生产厂对原料供应商的审计Pharmaceutical production plant audits to the raw material suppliers 从源头开始，对产品质量的保证 Product quality assurance starting from the source, * 供应商审计 * 物料的分类Material classification 物料的分类：原料、辅料、包装材料。 Classification: raw material, excipient, packaging material 原料+辅料： 起始物料， raw material + excipient: starting material 原料： 有活性的物料，API，raw material: API 关键物料：对产品质量有关键影响的物料，在原料、辅料、包装材料中都有关键物料，如何决定是否关键物料，需要我们科学合理的评估。Key materials: materials have critical impact on product quality, key material is in the raw materials, auxiliary materials, packaging materials. How to decide key materials, we need a scientific and rational assessment. * 供应商审计 * 供应商审计的必要性和重要性The necessity and importance of supplier audits 法律法规的要求：必要性， The requirements from the law and regulations issued by government 中国GMP的要求：第76条的要求，质量管理部门应会同有关部门对主要物料供应商质量体系进行评估， Chinese GMP, ITEM 76: Quality department has the responsibility to perform the audit to asses the quality system of the main vendor with related departments WHO GMP第8.8条：质量管理负责人有义务协同其他部门批准能提供符合要求的起始原料和包装材料的供应商，WHO GMP item 8.8: Quality management have the responsibility with related departments to approve the manufacturers, they has the ability supply qualified starting materials and packaging materials, WHO GMP第8.9条：对供应商的评估特别要重视供应商的历史和所供应物料的性质，在审计时，首先要确定供应商符合GMP的能力。 WHO GMP item 8.9: The assess to vendor should pay attention on the history and material characteristics, and verify the ability of the vendor about they perform the GMP. * 供应商审计 * 供应商审计的必要性和重要性 The necessity and importance of supplier audits 药品质量是对社会的一种责任：必要性， Drug quality is a responsibility to society: necessity  药品是用来治病救人的， The drugs are used to save lives 药品是为了延长人类的生命，Drugs is to prolong human life, 药品是为了提高人类的生活质量，The drugs are designed to improve the quality of human life, 药品生产企业必须对病人负责，Drug manufacturers must be responsible for the patient, 药品生产企业必须对病人的家人和朋友负责，Drug manufacturers must be responsible for the patients family and friends, * 供应商审计 *