AFA’s expertise and organization allows to perform audits to your raw materials or services’ supplier with total trustworthiness, wherever they are located.
Our great team of local auditors endows AFA of knowledge, flexibility and availability to perform audits worldwide. All audits are aligned with the criteria and requirements of the Health Authorities.
Based on several years of experience, AFA’s methodology ensures total impartiality and confidentiality during the whole audit process.
Since 2005, AFA has been performing on-site audits to raw materials and services’ suppliers for drug manufacturers. AFA’s methodology covers whole auditing lifecycle, from audit organization up to CAPA follow-up.
AFA strong qualification system and follow-up training programs assures maximum competence of our auditors, independently of their location. AFA has available auditors teams in different European countries, North America, China, India, Japan, etc.
AFA’s methodology, reference for third-party auditing bodies, has been recently reviewed to include remote audits’ execution, from which several improvements are also applied to face-to-face audits, as the reinforcement of a phase I for auditee information and documentation evaluation.
AFA’s technical department assures harmonization and homogeneity of the different audits during the entire cycle, from preparation to revision of the outcome. AFA applies a uniform criteria, aligned with Health Authorities requirements.
Our Quality System was developed to achieve full harmonization between our processes, staff, efficiency, technical criteria and GMP requirements. Our Quality System was accredited according to ISO 17020 in 2013.
Remote audits could be a must in exceptional circumstances, but they must be performed assuring its trustworthiness. AFA methodology assure that remote audits are performed assuring it!
When exceptional circumstances arise, the necessity to keep on qualifying the pharma suppliers, triggers innovation to look for alternative tools to continue auditing materials and services’ suppliers in pharmaceutical industry.
AFA developed, optimized and successfully implemented a methodology to carry out remote audits. This was possible thanks to our experienced and skilled team of auditors, long-term knowledge and the use of trend-setting communication tools that allow for efficient document and facility review.
Our global and long-experienced auditors team, allows AFA to perform remote audits looking for proximity and collaboration with the auditee, sharing language, time zone and knowledge about local industry.
AFA methodology for remote audits consists of two phases:
First phase – Information:
Exchange of information and documentation with auditee.
Information evaluation and challenging.
Focus of approach and objectives for second phase.
Second phase – Telematic meeting:
Assessment of consistency of all information obtained.
On-line inspection of facilities, records, electronic data, etc.
Thanks to our long- term presence in the business, many of the auditees have already been inspected before (some of them on many occasions) by AFA.
This is an essential part within the first phase of AFA’s methodology, which together with the public information, which is collected and evaluated, allows us to have more detailed information about them prior to the audit.
Once the audit exercise is executed, its trustworthiness is determined through a risk assessment.
It identifies the main findings of the audit, the recommended period of validity of the report and the ongoing actions to be taken.
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