API, Excipients, Packaging material Manufacturers

Any active substance (API), excipient and primary and secondary packaging material manufacturer responsible for the GMP compliance of supplied products

BENEFITS OF AFA

Economical	Reduction of the company resources dedication to develop the intensive audit plan required by clients, both to the initial and the renew audits. Flexibility when planning audits.
Confidentiality	Guaranteed confidentiality of any information received. Reports are personalized according the specific requirements of each sponsor.
Quality · Proven Competence	Qualified Auditors. AFA’s qualification program. Intercompany protocol to regulate the audit activities
Regulatory	AFA audit reports have been reviewed in many GMP inspections since 2005, always with successful results (EU, USA, Australia, and Canada).. Centralized follow-up of CAPAs derived from the audits and audit follow up after the expiration date. Taking advantage of AFA’s privileged position to interact with the authorities, regulatory bodies and other Pharmaceutical Associations.

The Asociación Fórum Auditorías (AFA) 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.