Research On Key Risk Factors Of Pharmaceutical Clean Room Environment Based On GMP

Medicines are special products related to human health.The quality of medicines has a lot to do with the clean environment of medicine production.Microbial and dust particles in the pharmaceutical manufacturing environment directly threaten the quality of medicines.Maintaining a long-term stable and clean environment in the production of medicines is a key link to ensure the quality of medicines.Since the Shandong vaccine,poison capsule and other drug incidents,drug safety has caused widespread concern throughout the society.In the academic world,the safety of pharmaceuticals was often considered from the perspective of pharmaceutical production technology.Later,it was discovered that the environment for pharmaceutical production,especially the clean environment in the production process,will also affect the quality of pharmaceuticals.Therefore,the environmental risks of pharmaceutical clean rooms have increasingly caused Value."Good Manufacturing Practices",referred to as GMP for short,is the basic principle of pharmaceutical manufacturing and quality management[1].This research is based on GMP and focuses on the environmental risks of pharmaceutical clean rooms.The research mainly includes the following parts:First,combining the concepts and theories of the pharmaceutical clean room and its controlled environment,the theory of risk management,and the requirements of GMP risk management,the common methods of risk identification and risk assessment analysis are used to identify the risk factors of the pharmaceutical clean room environment through literature review.Then,the identified risk factors were revised by expert interview method,combined with literature research and expert opinions,the identified and revised risk factors were divided into five categories,and a list of environmental risk factors for pharmaceutical clean rooms was established.Then,combined with risk management theory and structural equation model,a structural equation model for environmental risk assessment of pharmaceutical clean room is constructed.Secondly,by conducting a questionnaire survey on employees whose work is related to the clean room of pharmaceuticals,after obtaining the data,SPSS 25.0 was used to perform descriptive statistical analysis,reliability and validity tests on the obtained data.Then use AMOS23.0 software to perform data fitting,evaluation,and correction of structural equations to obtain the optimal model and obtain the final output result.Through calculation and analysis of the model results,the risk impact value of each risk factor on the environment of the pharmaceutical clean room is obtained.According to the impact value,the risk factor is divided into three levels according to the risk impact value,and the first-level risk factor with the most influence is regarded as the key risk factor.Finally,for the key risk factors analyzed,risk control strategies or management recommendations are proposed from multiple perspectives.