製薬用連続モニタリングに関するコンプライアンス，リスク，所有コストの比較　有線の，無線，および独立型モニタリングシステム

摘要

Recent agreements between the US FDA and its European Union counterparts to cooperate on pharmaceutical plantinspections to enable stepped up enforcement of safety guidelines require every pharmaceutical manufacturer to be onhigher alert to maintain a best-practice focus on quality systems. These agreements will help regulators be more e?cientwith their resources. Mutual agreement among agencies, combined with a focus on risk-based processes, raise the likelihood of more GxP facilities being audited. Revisiting cost-vs.-bene?t analyses for continuous monitoring modalities (wiredor wireless networks and standalone monitoring instruments) that facilitate the ability to comply with auditors' requests forproof of regulatory compliance is very timely. Moreover, the ever increasing costs for APIs and the R&D e?orts to createthem are such that the economic costs of failure in the totality of monitoring systems are greater than ever before. Allmonitoring methods whether wired, wireless or standalone instrumentation need to be scrutinized for systemic weaknessesthat allow human error to compromise product quality, system failure probabilities and overall costs of ownership. Thiswhite paper discusses ?ve approaches to monitoring critical environments such as pharmaceutical freezers, stability roomsand warehouses. Quality, facility and IT managers employ di?erent methods for maintaining the quality products and information. This paper evaluates each the di?erent methods and presents the risks and cost of ownership for each type