Reporting

  1. Issuance of the draft report: in approximately 5 weeks after the audit performance; the auditor issues the audit report draft, which is sent for review by AFA technical staff and by the audit sponsors.
  2. Issuance of the audit report: once the review period is finished, AFA issues the final version of the audit report, which is printed and signed. The original audit report is sent to each sponsor.

The audit reports are organized to cover all EMA requirements with regards audits performed by 3rd party entities. The main contents of the audits reports are:

  • Executive Summary
  • Observations
  • Audit team
  • Methodology, Audit approach and Audit Duration
  • Audited Company Information
  • General GMP evaluation (Quality Management and Organization; Personnel; Buildings, Facilities and Equipment; Computerized Systems; Documentation and Records; Materials Management; Production Operations; Quality Control; Supply Chain; Validation)
  • Products Information (Batch Records, PQR and Process Validation)
  • Conclusions
  • Additional Information
  • Auditors’ Curriculum Vitae
  • Declaration of Absence of Conflict of Interest

All reports are reviewed in three stages:

  • Technical Revision
  • Formal Revision
  • Revision by the audit sponsor

Each sponsor of the audit assign a validity period to the reports. Despite of this, AFA assign an internal validity period to manage the possible follow-up audits with the sponsors.

  • Reports prepared by AFA (new audits and database audit reports) are totally managed in an electronic way. The reports are sent in PDF format and digitally signed: ·Digital signatures are issued by FNMT (Fábrica Nacional de Moneda y Timbre) having legal validity. · Electronic Reports ease the customers knowledge management by using their own Documentary Computerized Systems
  • All AFA customers have an acces to an exclusive secure area in AFA website to download the audit reports.
  • Electronic signature and distribution process has been formally validated