Beyond quality: securing the supply of pharma ingredients

Rx-360 has identified six key elements that drugmakers should consider when trying to secure the supply of starting materials, including ingredients.

A survey of the supply chain security groups' member companies - carried out by its recently formed upstream supply chain committee - found a number of recurrent themes that will be developed into a white paper published later this year.

The chair of the committee - Rob Welsh - told a recent IPEC Europe seminar on pharmaceutical excipients that key supply chain security considerations for the upstream supply chain emerging from the survey included: raising awareness; supply chain mapping; intended use; risk assessment tools; supplier questionnaires and surveys; and change control/notification.

"You really need to create a culture of awareness around this issue that extends beyond quality control," said Welsh, for example by paying close attention to primary and secondary suppliers to make sure they are adhering to robust practices.

On the issue of awareness, 75 per cent of respondents had a supply chain security focus, and 97 per cent said they took measures to make sure their products were not adulterated or misbranded. Those surveyed shared a number of best practices, including standardised systems for reviewing paperwork for shipments, tamper-evident packaging, the use of photo libraries to identify packaging deviations - which has been endorsed by the FDA - and adulteration testing of at-risk materials.

Supply chain mapping is an essential tool for companies to employ in order to have good understanding of where raw materials are actually coming from, and a little over 50 per cent of survey respondents indicated they employed this approach. The white paper will elucidate some of the methods that can be deployed for this purpose.

On the issue of intended use, Welsh noted that while raw materials may be technically suitable for use in pharmaceuticals, the supplier may not actually intend to serve that application. That means the supplier may not understand the importance of providing notification of changes to the production process, for example, that could impact on the suitability of the material for use in medicines.

A major focus of the white paper will be on risk-mitigation tools, designed to limit the risk of problems creeping into the raw materials supply chain, such as hazard analyses for economically-motivated adulteration, counterfeiting, diversion or theft, as well as geopolitical factors such as natural disasters, contamination or work stoppages etc.

Questionnaires and surveys can be a very valuable tool when keeping tabs on supply chain, but the Rx-360 survey found considerable variations between pharma companies in the way this is carried out. Moreover, 65 per cent of suppliers had no standard operating procedures (SOP) in place to respond to manufacturers queries, suggesting some form of common template might be useful to increase the speed and accuracy of responses.  Rx-360 has already developed a template for excipients but wants to do likewise for other starting materials.

Finally, change control and notification was identified as a major issue in the survey, with around 70 per cent confirming that this was an area of disconnect between pharma manufacturers and suppliers. The industry would profit from developing robust supplier agreements so each party has a clear idea of factors that can affect quality.