5/6 March 2024
With the start of the new FDA initiative "Pharmaceutical cGMPs for the 21st century" the FDA has also introduced a risk-based approach. From now on, almost every pharmaceutical activity shall be in the focus of this risk-based approach. The aim is to check the implementation of the risk-based approach within the framework of the FDA inspections in the future. The FDA has not yet given any concrete statements on how to implement the risk-based approach.
Here, a draft published by the Global Harmonization Task Force (GHTF) may help. The members of this organisation are representatives both of the industry and of the authorities (also from the FDA). The founding members are the EU, the USA, Japan, Australia, and Canada. Their goal is to harmonise the regulatory requirements on medical devices.
Recently the GHTF has published a draft under the title "Risk management as an integral part of the quality management system." This document describes extensively how risk management can be implemented from the development to the sale of medical devices. It refers to the EN ISO 14971 (Application of risk management to medical devices), but goes beyond it.
What is particularly interesting is that this document aims at another subject that is presently much discussed in the pharmaceutical industry: CAPA (corrective and preventive actions).
The interaction between CAPA and risk management becomes clear from the following flow chart:
(Please click on the illustration for a larger version.)
Ill. 1 CAPA and Risk Management Flow Diagram by GHTF
Further risk analysis techniques mentioned in the GHTF document are e.g.:
Comments on this GHTF document can be handed in until 18 May 2004. To view the document, just click here. Author: