AFA’s Quality system is aimed at assuring the quality and excellence of the auditing services offered, in accordance with ISO 17020 requirements. Additionally, requirements set forth in ISO 19011 – Guidelines for auditing management systems are also considered.
Through a set of different procedures, followed by staff and qualified auditors’ AFA’s quality system is driven to fulfill the following objectives:
AFA was accredited as ISO 17020 GMP inspection body by ENAC, Spanish Official Accreditation Entity, in 2013. Since 2017, the scope of the accreditation also covers GDP audits. AFA is regularly inspected by ENAC to keep the ISO 17020 Accreditation.
One of the main challenges in the performance of successful, reliable audits is looking after competent candidates who can face versatile and demanding audit processes.
Selection and qualification of auditors is a rigorous, complex process, where candidates are continuously evaluated until their competence is proven.
Initial evaluation of candidate profile (basic education, experience and skills).
A University degree in life sciences areas or engineering, experience in GxP regulated environments and experience in auditing GxP environments are a must.
Signature of confidentiality terms, training in AFA methodology and design of qualification process according to candidate’s curricula and experience. It includes performing audits with qualified senior AFA auditors to evaluate their performance (both technical knowledge and skills during the audit, and reporting attributes) until their competence and skills are demonstrated.
When the audit skills and adaptation to AFA methodology is proven, the candidate is approved as AFA qualified auditor. Auditors are qualified to perform certain kind of audits (i.e. API manufacturers, distributors, finished dosage forms manufacturers) according to their experience and competences.
Auditors’ performance is revaluated every 2 years. In addition, auditors receive continuous training in changes or news in regulations or AFA methodology, and in needs for specific, challenging topics that may have been detected by AFA’s technical staff.
