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IPEC-Europe

Since January 2010, the Asociación Fórum Auditorías (AFA) has joined the IPEC- Europe International Pharmaceutical Excipient Council) as a stakeholder.

The Fórum Auditorías association is aware of the importance of being in contact and present in the main European forums related to the supply chain validation processes. This is the reason why AFA has been integrated as a collaboration party into IPEC. IPEC is an international organization (IPEC-Europe, IPEC-Americas, IPEC Japan o JPEC), grouping geographically the main manufacturers of excipients that supply products to the Pharmaceutical industry. However, it must be highlighted that IPEC is not only formed by manufacturers of excipients but also important international pharmaceutical companies and distributors, with the aim of working together to improve the mutual relationship and the regulatory compliance optimization.

In this respect, IPEC-Europe has created various working groups composed by members of the organization who are organized into committees by common interest subjects. The following working groups are currently in operation:

Certification Project Comitee
Quality&Regulatory Affairs Comitee
Harmonization Comitee
GDP Comitee

Apart from these working groups, IPEC-Europe has issued a series of guidelines on Good Distribution Practices (GDP) in manufacturing and Good Manufacturing Practices (GMP) compliance, control and distribution of excipients for the Pharmaceutical industry. These guidelines are the result of this mutual collaboration between manufacturers and consumers of this type of pharmaceutical components.

In this sense the following documents should be highlighted:
2011 The IPEC Good Distribution Practices Audit Guideline
2010 The IPEC Excipient Stability Program Guide
2009 The IPEC Excipient Information Package (EIP): Template & User guide
2009 The IPEC Quality Agreement Guide & Template
2008 Qualification of Excipient for Pharmaceutical Use
2008 The IPEC-PQG Good Manufacturing Practices Audit Guideline
2006 The IPEC-PQG Good Manufacturing Practices Guideline
2008 The IPEC Good Distribution Practices Audit Guideline
2006 The IPEC Good Distribution Practices Guideline

These guidelines, as well as additional information related to the structure, members, organization, working groups, etc., are available on the IPEC-Europe (Guidelines).

The Fórum Auditorías association is aware of the importance of the initiatives that, at a European level, are being developed around the certification process of excipients for the Pharmaceutical industry. This is the reason why AFA has not hesitated in joining IPEC-Europe as a stakeholder in order to know the activities that are being developed and evaluating a possible collaboration and participation in the definition project for the certification of excipients as key components in the formulation of drugs.