Journal of GXP Compliance, Vol.13 No. 1 (Winter 2009), Pp. 79-89
Page 79 “Framework for Continuous Improvement,” Journal of GXP Compliance, Vol.13 No. 1 (Winter 2009), pp. 79-89. Gordon Welty This article considers occasions that lead to the • Regulatory investigators continuous improvement of GMP processes and the • Health care providers revision of SOPs. Five groups of stakeholders in the • Patients and other health care consumers. sphere of FDA-regulated industry are identified: operational employees, quality unit auditors, regulatory investigators, health care providers, and In brief, operational staff manufacture the patients. The kinds of observations that tend to be regulated product, be it a drug, medical device, associated with each of these stakeholders are: nutritional supplement, etc. The quality auditors escalated events tend to be associated with employees; function independently to monitor the activities internal audits with auditors; 483 observations with of operational staff as well as the quality regulatory investigators; adverse events with health attributes—the safety, identity, strength, purity, care providers; and customer quality complaints with and quality (SISPQ) of the product. Agency patients. These observations initiate an investigation investigators in turn regulate the activities of and revising process that varies in emphasis but that both operational and quality staffs. Healthcare has an underlying logic. An observation is typically providers prescribe the product, and patients escalated, triaged, and can become the basis of an investigation and root cause analysis. At the utilize the product. conclusion of the investigation, remediation can be proposed in the form of CAPA, and may ultimately Any member of these groups can make an lead to the revision of an SOP. A diligent approach to observation that may bring about an revision promotes the continuous improvement of the investigation and root cause analysis.
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