Establishment Of Clean Environment Monitoring System In Pharmaceutical Manufacturing Workshop And Its Application Effect

As a typical controlled environment,the clean production environment of pharmaceutical company occupies a very important position in its operation and management.China's 2010 version of GMP puts forward more strict requirements for the pharmaceutical clean environment.Pharmaceutical company need to establish a set of scientific and strict management system,invest more manpower and material resources to effectively monitor the clean production environment which in order to ensure that it is in the controlled state required for production.In this study,the monitoring methods of pharmaceutical clean environment are deeply studied;the relevant laws and regulations in domestic and foreign country,the implementation guideline requirements of the 2010 version of GMP are all consulted;combined with the practical experience of the foreign pharmaceutical company in environmental monitoring,the environmental monitoring technology in pharmaceutical company is standardized and rationalized.The Standardized pharmaceutical environmental monitoring process including the scientific analysis of the pollution sources and their transmission routes in the production clean environment,grasping its formation law;making risk assessments for the clean room environment in order to draft the reasonable and applicable sampling plan for the pharmaceutical environmental monitoring;establishing a perfect environmental monitoring system,carry on the systematic and comprehensive pre-induction training to the front-line production managers and operators;conducting effective trend evaluation for the daily environmental monitoring data,regularly review the monitoring data to assess the effectiveness of environmental monitoring and timely identify the potential quality problems;carrying on the effective deviation correction to the environmental monitoring which have exceeded the action limit;analyzing and identify the pollutions;mastering the types and changing trend of the microbial pollutions which found in production environment;establishing the reasonable microbial library for the production clean environment;providing the valuable information for the quality deviation investigation.Combined with the series of clean production environment monitoring measures mentioned in this study,the effect analysis and verification were carried out by xx Pharmaceutical company.The verification results show that the standardized production clean environment monitoring measures can ensure that its production clean environment is in a continuous and qualified controlled state,the qualified rate of its production products is guaranteed and improved which means the quality of products is in a continuous state.This study has universal reference value for the pharmaceutical company and will provide useful technical support and reference for the pharmaceutical company to carry out the effective clean production environment monitoring.