PROFILE

ABOUT AFA

Who we are	International Association of Pharmaceutical Companies. Founded in 2005 and ruled by an intercompany protocol reviewed by Spanish Health Authorities and approved by all affiliated members..
AFA Mission	To provide an effective infrastructure to satisfy the requirements on suppliers validation. Win-win solution. AFA provides services to affiliates and non affiliates.
AFA scope of activities	AFA is an International Association that is covering audit needs to companies worldwide.
Audits type and location	API, Excipients, Packaging, Logistics, Analytical Laboratories. Audits worldwide.
How AFA is ruled?	AFA is ruled by an intercompany protocol reviewed by the Spanish Health Authorities (AEMPS) and approved by all affiliated members and accepted by the sponsors of the audit.

ACTIVITY and SERVICES

Yearly Activity:	Approximately 70-80 audits per year: 80% APIs 15% Excipients 5% others (Packaging materials, Analytical Laboratories, Software, etc.)
Number of available audit reports	More than 300 audit reports are available in our Database.
Audit Optimization Approach	Annual package with general interest audits (Optimized Audit Plan, OAP). Joint sponsorship of audits by common interest or by campaigns for distant geographical areas, sharing travel and accommodation expenses.

BENEFITS OF AFA

Economical	For affiliates 15% saving cost in all services (including the available audits). Payback if the audits promoted (or co-promoted) by the affiliates are bought later by another company (half of the fee paid by the new company). For any Pharmaceutical Company Possible subscriptions to OAP (Optimized Audit Plan) Best ratio quality / price. Reduction of the audit cost by optimization
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. More than 300 audits performed since 2005.
Regulatory	AFA audit reports have been reviewed in many GMP inspections since 2005, always with successful results (EU, USA, Australia, and Canada). Covering the complete life cycle of the supplier relationship. Follow up of CAPA derived from the audited companies and follow up audits after audit expiration date. Taking advantage of AFA’s privileged position to interact with the authorities, regulatory bodies and other Pharmaceutical Associations.