European Fine Chemicals Group Issues Assessment Tool to Promote Supply-Chain Security

June 25, 2009
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Following the 2008 launch of the European Fine Chemicals Group (EFCG) Voluntary Guidelines (VGs) to promote supply-chain security, the group has now announced the official launch of an assessment template that will allow fine chemicals customers and suppliers to assess and implement this new set of recommendations.

Following the 2008 launch of the European Fine Chemicals Group (EFCG) Voluntary Guidelines (VGs) to promote supply-chain security, the group has now announced the official launch of an assessment template that will allow fine chemicals customers and suppliers to assess and implement this new set of recommendations.

During a press conference, held last week at Chemspec Europe’s annual meeting in Barcelona, Spain, board members of EFCG unveiled the BIEN (Business Integrity EvaluatioN) template-an assessment tool developed by EFCG and BSI Management Systems in Germany, to assess compliance with the newly-developed VGs.

Created to promote the highest level of risk-management in the manufacturing of non-GMP intermediates and active ingredients, the VGs set out minimum requirements for all manufacturers in the non-GMP, ISO-regulated fine chemicals industry.

“EFCG has been working hard to promote supply-chain security to the crop protection business and that has really been the driving force of its strategy,” Allan Laing, CEO of Pentagon Chemicals (Widnes, UK) and chairman of EFCG’s intermediates and agrochemicals manufacturers group, explained during the press conference. EFCG is now heavily promoting this strategy to all EFCG member companies, including those companies that service the pharmaceutical industry.

“The general concept that surrounded the VGs being developed was really to combine the elements of the ISO standards that we were already familiar with but to build further on some aspects which members felt strongly about. Particularly in the area of purchasing and the whole supply chain, from the product purchasing to the product stewardship and indeed the delivery of products,” said Laing.

According to EFCG, the new guidelines are not simply an extension beyond existing legislation and regulation, but they also embrace a set of business processes and best practices used before, during, and after manufacture, which apply to any supplier or customer along the supply chain.

Under the leadership of Lukas von Hippel, vice-president of marketing and sales at AllessaChemie (Frankfurt, Germany), the BIEN template was developed to assist companies to meet these guidelines and to assess suppliers, quickly, and cost-effectively.

“From October 2008 to date, many of our member companies have been testing the template internally and the general consensus is that it is a valuable tool; it’s very practical and compatible with suppliers to the fine chemicals industry. Further, it is not time-consuming; the time for an onsite evaluation, we estimate, should not exceed half a day,” Laing noted.

The BIEN framework template was developed against the following key objectives:

  • Customers will be able to evaluate suppliers and vice versa

  • The template will provide a quick, low-cost VG evaluation tool

  • There will be clear interpretation of results

  • Assessments can be performed in-house without the need for external auditors

“The BIEN template has been designed to assess whether a company is in-line with the VGs and it gives every company a chance to improve on those areas where it is not compliant,” explained von Hippel.

“The guidelines that have been developed by EFCG are voluntary; we try to promote the benefits of voluntary participation within Europe as much as possible,” emphasized Laing. “It is also important to note that, although the VGs have been in use for some time in Europe, we have already started to spread the message worldwide and we’re currently in discussion with some Japanese and Chinese agencies,” he added.

“We hope that, in time, the VGs will become standard, like Responsible Care, and will be viewed as something that people trust,” said von Hippel. “In order to do this, we must raise standards. Raising standards means to secure supply chain, to protect environment, and to improve in general. This is exactly what the VGs aim to do,” he concluded.

The BIEN template will be made available this week on the EFCG website.

Fedra Pavlou is editor-in-chief of Pharmaceutical Technology Europe.