Logo EFCG.About EFCG

EFCG was launched as a sector group of CEFIC in 2004 to deal with common business and political issues affecting European fine chemicals producers. APIC - the Active Pharmaceutical Ingredients Committee - provides its technical leader-ship. EFCG's vision is to sustain value creation for its members through competitiveness, growth and environmental performance, and that this is recognised by society. EFCG's mission is to be the voice, the focus and the forum of the fine chemicals industry in Europe.
  

News: Excipient Certification Project

Following on from the memorandum of understanding signed by EFCG and IPEC-Europe at the last EFCG Conference in Lisbon in 2008 both parties have been progressing the realisation of an excipient certification scheme. IPEC Europe has called on its sister organisation IPEC-Americas and partners, the UK Pharmaceutical Quality Group (PQG) and the European Association of chemical Distributors (FECC) to join forces to realise this ambition. An international project has been established and is working to develop the key elements that will make up a successful scheme.

The Certification project is currently working on the following aspects:

  • Excipient Classification
  • An Auditable GMP Standard
  • An Auditable GDP Standard
  • A Definition of 3rd part auditor competency and training requirements
  • Certification scheme rules and agreements for 3rd party auditors and participants

As highlighted by EFCG in their position paper on the subject in 2007 a "one size fits all" approach to excipient GMP is unlikely to be appropriate. Some excipients due to their nature or use will demand a higher degree of assurance with regard to their purity and quality. Thus work is in progress to develop a system that will allow suppliers and users to classify excipients, either in isolation or as a joint exercise. The initial thoughts on this classification scheme will be shared with the audience.

With excipients classified, a definition and re-definition of the GMP required is necessary. The existing IPEC-PQG GMP Guide will be used as the foundation. Enhanced requirements involving greater application of the basic GMP principles in the GMP guide will be applied to the higher classification of excipients.

As recent adverse events have highlighted time and again controls over the distribution chain require that GDP principles be included in the scheme for both manufacturers and distributors of excipients. At this time a single definition of GDP for all excipients is planned.

As highlighted by the authorities on numerous occasions any 3rd party auditors will have to be competent to perform GMP and GDP audits of excipient suppliers. As a result a definition of what these competencies should be and the training required for such auditors will be developed. Close contact is being kept with the regulatory bodies on this topic.

With these 4 components in place, a system where existing 3rd party auditors can apply to perform audits will be developed. Two types of "certificate " are anticipated. One will be an annex to an ISO 9001 audit and be performed by organisations that conduct ISO audits already. This allows access to a large group of auditors and from a supplier perspective can be a relatively easy "step up" to a visible demonstration of GMP and GDP in their organisation. The second kind of audit will be more akin to a regulatory inspection and this will result in a comprehensive audit report which the supplier could share in full with users.

The current status of this ambitious project will be discussed and feedback sought from the audience! Details of the project will be discussed at EFCG's 4th Conference in Brussels, 13 - 14 May 2009