兽用生物制品生产过程中的偏差管理

Deviation Management in the Production of Veterinary Biological Products

在兽用生物制品生产过程中,偏差不可避免,而偏差的发生则会为产品质量埋下了某种程度的隐患(质量风险)。如果不进行偏差管理,就会使得实际生产过程越来越偏离预先批准的程序,甚至发生重大质量问题。为了保证产品的质量,进行严格有效的偏差管理是兽用生物制品生产质量管理的重要内容。文章从偏差识别、偏差分类、偏差调查、纠正和预防措施等方面着手,阐述了兽用生物制品生产过程中应怎样进行偏差管理。

Deviations are inevitable in the production of animal veterinary products.The occurrence of deviation will sow hidden trouble(quality risk)for product quality to a certain degree.If deviation management is not carried out,the actual production process will deviate more and more from the pre-approved procedures,and even serious quality problems will occur.In order to ensure the quality of products,strict and effective deviation management is an important content of quality management for production of veterinary biological products.From the aspects of deviation identification,deviation classification,deviation investigation,correction and preventive measures,how to carry out deviation management in the production of veterinary biological products was discussed in this paper.