《质量风险管理与药品检查孙京林》ppt课件模板.pptVIP

Communications within the company, to the share holders and the NRA QRM when integrated into quality systems allows for scientific assessments of product failures and Corrective Actions and Preventative Actions (CAPA) World Health Organization * * Risk is defined as probability and Severity of harm and as the probability or severity increases the Risk and Harm increases. E.g . Inactivation , of Tetanus Toxin: If the probability of reversion due to poor inactivation is high; since the process has not been validated then the severity is high thus increasing risk exponentially. World Health Organization * * World Health Organization * * the inspector could check the company maturity of GMP attitude and compliance by analyzing the trend analysis, the behaviour of the company toward the complying of the GMP maturity classified as follow: PATHOLOGICAL company For the pathological company, from the trend analysis, we found that all the result lay in the area above the acceptance criteria We haven’t ever been caught, so we must be doing pretty good REACTIVE company Compliance is important, so we do a lot every time we have a problem PROACTIVE Company We work sensibly on the problems that we still find GENERATIVE Company Compliance is just part of how we do business here, we found the attitude of the company toward the complying with GMP requirement, as we found the company always keeping the result below the alert limit, if there is any division in the result will be followed by investigation CAPA will be taken World Health Organization * * In module 1 was mentioned that Quality should maintained throughout the product lifecycle. Among the goals of each product lifecycle stage, the Pharmaceutical Development stage has the goal to design a product and its manufacturing process to consistently deliver the intended performance and meet the needs of patients and healthcare professionals, and regulatory authorities and internal customers’ requirements. On the