中药生产企业内控质量标准的制订

Work Out the Internal Control Standard in the Pharmacy Enterprise of Traditional Chinese Medicine

目的制订中药生产企业内控标准。方法总结近20年的药品生产质量管理经验,研究相关法律、法规和标准。结果制订中药内控标准,应注重建立内控标准体系,注重源头控制、整体控制和过程控制;主要包括增订控制项目、修订检验方法和限度标准、方法学验证等几个方面;还应考虑可行性、必要性和经济性。结论制订高于法定标准的内控标准,具有重要意义:一是更好地确保产品安全、有效、均一、稳定;二是确保产品在有效期内符合法定标准规定;三是增强企业核心竞争力。

Objective work out the internal control standard in the pharmacy enterprise of TCM. Methods Summarize the relevant experience near 20 years, study related law, regulations and standard. Results Work out internal control standard： should emphasize to establish a standard system, emphasize fountainhead control, overall control and course control; the major aspects include enlarging control project, revising methodology and limit,carrying out validation, the feasibility,necessariness and economy should be still considered. Conclusion Internal control standard is important to： firstly, ensure the safety, effective,homogeneous and stability of the product; secondly, ensure product in line with the legal standard in validity~ thirdly, strengthen enterprise key competition ability.