Problems And Countermeasures Of Quality Control Laboratory Of Pharmaceutical Production Enterprises In Henan Province

Quality control laboratory plays an extremely important role in the quality management system,in the whole process of pharmaceutical production,the formulation of pharmaceutical quality standards and in the market entrance right quality control laboratory plays an irreplaceable role.This article is written from a lot of reference of literature so as to get an understanding of the duty and importance of quality control laboratory.Moreover,the author gets access to the book pharmaceutical GMP guidance.Through this book,the author understands the requirement made by pharmaceutical GMP on the laboratory quality control.After a summary of the examination result made by Henan Province pharmaceutical Review Center for pharmaceutical production enterprises and an analysis in the existing problems,the author finds out the disadvantages of Henan Province pharmaceutical production enterprises and put forward reasonable suggestions according to the actual situation.In this paper,literature research,investigation and other methods are adopted to problem analysis of the quality control laboratory of pharmaceutical production enterprises in Henan province.The results show that in the search of "quality control laboratory" in China’s CNKI database,102 literatures were retrieved with only 55 related to the theme by the end of March 1,2016.And among which,only 5 are really close to pharmaceutical production enterprise quality control,accounting for 11% of all relevant literatures.Therefore,the current research on the status quo of the laboratory quality control of pharmaceutical production enterprises is relatively short.Through the study of pharmaceutical GMP guidance,the author gets an understanding of the specific requirements of GMP pharmaceutical quality control laboratories,such as personnel,file system,sampling and sample material,product inspection,commissioned inspection,quality standard,reagent and sample solution,standard and control products,laboratory equipment and analytical instruments as well as the original data.Research results show that the number of defects in the quality authorization,original records,on-site inspection area of pharmaceutical production enterprises in Henan totals 19,and the occurrence of instruments,documents,standards,measuring and sample defects are 15 times,13 times,14 times,12 times,12 times respectably.Moreover,the quality inspection,theory,equipment defects total 9 times,2 times and 3 times respectively.The result indicates that there exist more problems in the quality authorization,original records,on-site inspection,instruments,documents,standards,metrology,samples compared with quality control,theory and equipment among pharmaceutical production enterprises.The article is intended to achieve the following goals: First,understanding pharmaceutical GMP for quality control laboratory requirements;the importance and responsibilities of quality control laboratory of.Second,understanding the existing problems of the pharmaceuticals production enterprise quality control laboratory in Henan Province.Third,putting forward corresponding measures according to present problems so as to provide reference for pharmaceutical production enterprises to meet requirements of GMP,and guarantee the product quality and medication safety for patients.