本文摘要：A fresh look at an old topic: Investigations in the GMDP environment 老话新谈：GM/DP情况下的观察 Posted by:CallumMcLoughlin, In this post, I will share some common issues that the inspectorate often sees whilst out on inspection at companies of all s

A fresh look at an old topic: Investigations in the GMDP environment

老话新谈：GM/DP情况下的观察

Posted by:CallumMcLoughlin,

In this post, I will share some common issues that the inspectorate often sees whilst out on inspection at companies of all sizes and of all operating models, so you can consider your own company’s systems and practices and improve investigation outcomes. The concepts outlined in this post are equally applicable to deviations, customer complaints and several other Pharmaceutical Quality System (PQS) activities.

The systems supporting investigation activities and outputs should be monitored with trending to obtain meaningful information that can be used to drive routine improvements and ensure that approved timescales are met. This includes scrutiny during management review and escalation where needed to ensure the system remains in control and an effective means of protecting patients when things have gone wrong.

Investigations are an inevitableaspect of any manufacturer’s or wholesaler’s operations; whilst every company strives to put in place perfect systems and processes it is impossible to predict every potential failure mode and totally prevent incidents from happening.

Appropriate use of risk assessment is crucial where things have gone wrong and the impact on quality and efficacy, and the overall patient safety impact, must be accurately understood. Allavailable evidence should be used together to accurately establish all potential failure modes, likelihood of occurrence, detectability, or other factors which when taken together help appropriate decisions be made.

Effective root cause analysis willlead to the identification of appropriate and relevant CAPAs. These should:

Categories:Compliance matters, Good distribution practice, Good manufacturing practice

过于乐观的目的日期可能会以其他方式影响PQS公司应思量接纳任意的完成时间尤其是在应紧迫实施或确定了下一批生产的CAPA的情况下。

有效的基础原因分析将有助于确定适当和相关的CAPA。

这些应该：

这些方法包罗：

For example, while a seal failure on manufacturing equipment is the。

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