Excipient certification project moves forward

Representatives from pharmaceutical manufacturers, suppliers of excipients and regulatory authorities met in Brussels, Belgium, recently to discuss the role of third-party certification of excipient suppliers in improving quality assurance in pharmaceutical manufacturing and distribution.

The meeting was convened by the European Fine Chemicals Group (EFCG), the International Pharmaceutical Excipients Council (IPEC) Europe, FECC (the Brussels-based body representing the European chemical distribution industry) and PQG, a special interest group of the UK's Chartered Quality Institute that has published guidance on pharmaceutical quality and standards for packaging materials and excipients.

The event represents a key stage in a process started last year when the EFCG and IPEC Europe signed a memorandum of understanding to start work on a certification system for Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)¹.

With the European Commission shelving its plans to implement a Directive on GMP for 'certain' pharmaceutical excipients² some stakeholders feel there is more need than ever to develop alternative methods for assuring the quality and safety of these ingredients.

Excipients are currently covered by limited regulation and recent abuses by unscrupulous manufactures and criminals have recently hit the headlines, forcing manufacturers to request a greater level of excipient supplier audits.

Certification, which allows companies to be externally audited by an independent third party, is intended to ease the administrative burden on excipient suppliers, users and competent authorities. Additionally it will provide GMP and GDP standards that will improve assurance of excipient quality and safety, and help facilitate trade.

The certification scheme has four main components: classification of excipients according to risk; GMP; GDP; and auditor competency.

EFCG and IPEC Europe believe that including a classification system that matches the requirement for enhanced implementation of GMP with potential risks to the patient, the scheme becomes more holistic and inclusive.

The list of excipients and purposes for which they are used, as defined in international pharmacopoeias, is extremely long. Yet despite this complexity the feedback at the stakeholders' meeting was for a "simple" certification scheme.

The stakeholder meeting made it clear that some significant obstacles need to be overcome, including developing a classification scheme that is agreed upon by both users and suppliers of excipients, as well as establishing a workable system which will allow regulators to accept a third-party audit.

"This meeting was invaluable as it raised a number of challenges that will need to be addressed as the third-party certification project moves forward," said Patricia Rafidison, chair of IPEC Europe. "It was encouraging to see the high level of engagement shown on this topic by both industry and regulatory bodies, and I look forward to further dialogue on this important project."