EFCG unveils supply chain security template

The European Fine Chemicals Group has drawn up a template to help pharmaceutical manufacturers and fine chemical suppliers comply with a set of voluntary guidelines designed to ensure that they operate a safe and secure supply chain.

The voluntary guidelines are themselves a recent development, having been drawn up last year to provide a set of minimum manufacturing and distribution requirements for all manufacturers in the non-GMP, ISO-regulated fine chemicals industry. The new template provides a checklist to evaluate compliance with the guidelines.

Known as BIEN (Business Integrity EvaluatioN), the template has two parts. The first is a self-evaluation protocol which suppliers can use to prepare for an inspection, while the second is intended for use by pharma company staff, such as procurement managers, when they carry out a site visit to a supplier.

Using the approach site visits should take no more than half a day, said Lukas von Hippel, VP Marketing and Sales at AllessaChemie, at a press conference which took place at Chemspec Europe in Barcelona last week.

The template will also provide a clear, unambiguous interpretation of audit results and should make it easier for companies to carry out their own assessments rather than bringing in external auditor companies. Its use will also provide an immediate feedback to the supplier from the evaluating customer, he said.

“We live and work in an increasingly global marketplace. [and] we enjoy making business with a variety of companies in different countries and cultures,” commented Hippel.

“However, we also see that there is a real need for improvements to be made along the full length of the supply chain, he continued. “We see that there are more and more issues arising from aspects of product safety, quality, reliability and cultural challenges.”

This shift to outsourced production and more complex supply chains could mean the risk of mislabelling, contamination or substitution of one substance for another is increasing.

Those issues were highlighted of course by the heparin scandal last year, but also a number of cases involving pharmaceutical excipients in recent years which have emphasised the need for robust risk-assessment by pharmaceutical manufacturers.

Use of the guidelines and template should help customers quickly decide if a supplier is reliable and secure or not, said Hippel.

A draft BIEN template was developed by auditing company BSI and was tested by members of the Agrochemical Intermediates Manufacturers in Europe (AIME) industry group in 2008 and 2009.

On the strength of that testing period an updated version was produced which is available on the EFCG website www.efcg.cefic.org.