药品原辅包供应商质量管理的方法探究

Research on Methods of Quality Management of Pharmaceutical Vendors for Pharmaceutical Raw and Auxiliary Packages

目的:探讨药品原辅包供应商质量管理方法,为提高企业供应商质量管理水平、降低由物料带来的质量风险提供参考。方法:建立供应商质量管理体系,从供应商选择、现场审计、质量协议和供应商评估几个方面阐述管理方法和要点,制定相应的标准和规范;并提出建议。结果:供应商质量管理体系的建立使更多优质供应商进入公司合格供应商目录,现场审计更全面有效,质量协议明确了供应商的责任和沟通机制,供应商评估综合了现场审计结论和质量文化等方面,对供应商的评价更全面客观。结论:建立供应商质量管理体系,可使制剂企业供应商质量管理工作更规范有效,确保物料供应持续稳定、质量可靠。

Objective: To explore the methods of quality management of suppliers for pharmaceutical raw and auxiliary packages, and to provide references for improving the level of vendor quality management and reducing the quality risk caused by materials. Methods: To establish the supplier quality management system, explain the management methods and key points from the aspects of supplier selection, site auditing, quality agreement and vendor evaluation, the corresponding standards and norms were formulated, and suggestions were put forward.Results: The method of vendor quality management enables more high-quality vendors to be included in the qualified vendor list of companies and makes on-site audit more comprehensive and effective. Responsibilities of suppliers and the communication mechanism are clarified by Quality Agreement. At the same time, the vendor evaluation integrates the on-site audit conclusions and quality culture, so as to make the evaluation of vendors more comprehensive and objective. Conclusion: The establishment of supplier quality management system could make the vendor quality management in pharmaceutical enterprises more normative and effective and ensure the continuous stability of material supply and reliable quality.