徐影针对药品生产理解并应用QRM全.ppt

* * * * 功能要求：合成车间A级区的功能?保护分装避免污染 潜在的失败模式：高效泄露；高效堵塞；风速达不到要求；风机坏了 失败影响：该区不受保护高效采用B级风进A级，A级速度不够大会造成B级区风进到A级区内，会导致产品污染 严重性：BATCH失败；可能25分or16分 失败原因：维护保养不到位。，损坏，风速过大；安装不到位 可能性：安装确认，选5分，见23页 可测定性：3分 这是一个大表，会有很多原因，会得出很多分，选分数最高的。 * * * * * Summarize today’s key points” ” and orally quiz trainees to make sure they are clear. 1 simplified formula risk=P*S (concepts of quality risk management, risk, hazard) 2 principles 3Tools ( Ishkawa, FMEA, and PHA) 4 main elements in process ( assessment, control, communication, review,) * * * Risk assessment is used in a general sense applicable to all industries. The main point this slide is making is that Risk management (again across all industries) is wider than just assessment and includes communication and management of risk in a wider sense. * * There are several words that are used to describe severity – consequence, impact mean the same thing in this application * * Quality Risk Management is focused on Risk to the patient. Remember not everything needs to be formal and tools may not be appropriate for simple RM. High risk to the patient demands more formality and documentation then lesser risks * QRM is part of 3 ICH documents that point the way towards a more scientific and knowledge based approach to developing and manufacturing drugs Line 1 is the current situation – small process understanding, higher risk and therefore a need for greater regulatory control ( both in dossier submissions and GMP) Currently we are in a situation where changes scrutinized and approved by the regulators – this can frustrate innovation. Line 2 is where some companies are. Higher process knowledge and less risk within a culture of continuous improvement. This happens after application of Q8 and Q9. Line 3 is where we want to get to. Minimal risk, maximum process understanding and minimum regulatory oversight. * * This is a definition and applies to any form of Risk management activity Draw on whiteboard the slide 76 process flow