PQG unveils 'how to' guide for reducing supply chain risk

A new guide has been launched to help pharmaceutical companies and their suppliers identify and manage risk in the supply chain.

The publication has been prompted by "globalisation and the quest for ever more cost effective means of supply", which has increased the complexity of the supply chain, according to the Pharmaceutical Quality Group, which developed the document.

The PQG, an industry group which has the aim of promoting appropriate GMP for the pharmaceutical industry and affiliate organisations, says that increasing complexity can in turn "reduce both the knowledge and understanding of the exposure to risk."

The guide, which can be downloaded here, has been published in the wake of serious incidents in which the integrity of the pharmaceutical supply chain has been compromised to allow substandard and adulterated ingredients to find their way into medicines.

Most notable is the heparin contamination incident in 2007 and 2008 which led to more than 200 deaths worldwide, although there have been a number of others involving both active pharmaceutical ingredients and excipients.

The guide covers various tools and techniques for managing supply chain risk and provides specific examples of how these are applied in industry, including the heparin incident, with advice on how the situations could have been improved or avoided.

Other examples include issues related to plastics used in packaging, printed artwork and the use of so-called 'facade' manufacturing facilities, where a company supplies not only API from its own factory, but also material originating from third-party suppliers, sometimes via traders and brokers, that is passed off as its own.

The guide will help drugmakers and their suppliers adapt to increasing use of risk-based management systems as laid out in the International Conference on Harmonisation guidance on quality risk management (ICH Q9).

That is important as the FDA and UK's Medicines and Healthcare products Regulatory Agency (MHRA) are now basing their inspections on a risk-management principle.

The Director of the MHRA's Inspection, Enforcement & Standards Division, Gerald Heddell, has provided a foreword to the guide which notes: "risk management should play a key role in supplier selection, approval and management process if the quality and continuity of medicines and medical devices is to be assured."

"Risks are part of life," he continues, "but it is imperative that processes are in place to identify and manage them in such a way that patients and healthcare professionals can continue to enjoy a reliable supply of safe and effective medicines and medical devices."