Risk Management Guide

The PQG Guide to Supply Chain Risk Management for the Pharmaceutical and Medical Device Industries and their Suppliers

Risk Guide cover

Threats to the supply chain feature in the top ten risks of most companies.  Globalisation and the quest for ever more cost effective means of supply has greatly increased the complexity of the supply chain which can often reduce both the knowledge and understanding of the exposure to risk. Within the context of globalisation, outsourcing and complex supply chains, there is an increasing emphasis on controls around product quality assurance and security of supply.
To help organisations and their suppliers adopt a common approach to risk management, the CQI’s Pharmaceutical Quality Group has developed a free downloadable, interactive PDF guide. The guide is based upon the quality risk management model defined by the International Conference on Harmonisation (ICH Q9).

Part of the team that developed the Guide

Members of the Guide development team and the Steering Commitee

The objective of the PQG guide is to help reduce supply chain risk through application of the principles and tools of risk management.  It emphasises the need for pharmaceutical and medical device industries to apply risk management when making sourcing decisions and should help suppliers understand regulatory requirements and expectations of the industries concerned. The guide promotes the use of risk management as a tool to understand customer needs and identify potential hazards that may exist within the supply chain.

The Guide is available in a user-friendly electronic pdf format from our shop in the e-publications section

PQG Members can also download the presentations made at the Launch meeting for the Guide in London by clicking on this link (You will need to log in as a Member before clicking the Link.)