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:
