HEALTH AUTHORITIES

Health Authorities are one of the key elements to prove the regulatory compliance from the API , excipients, packaging material manufacturers as well as those participating in the pharmaceutical products supply chain; and to prevent potential public health risks.

AFA guarantees the technical competence of auditors by means of a strict AFA auditor qualification program using a robust methodology that ensures a uniform approach with uniqueness criteria aiming to reach the highest rigor and quality in the audits performed.

BENEFITS OF AFA

Quality · Proven Competence	Technical Competence and demonstrated experience of auditors by means of a strict AFA auditor qualification program using a robust methodology in the execution of audits Uniqueness of acceptance criteria and criticality evaluation of the supply aiming to reach the highest rigor and quality in the audits performed. 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). Expanding the Quality Assurance concept to the supplier-related processes. Covering the complete lifecycle of the supplier relationship. Follow up of CAPA derived from the audited companies 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.
Confidentiality · Impartiality	Guaranteed Confidentiality between sponsors, auditors and suppliers by means of Confidentiality Disclosure Agreements (CDAs). The impartiality and absent of conflict of interest with the audited companies are guaranteed.