GxP Compliance at Eignapharma

GMP AUDITS (FDF & API), GDP AUDITS & GVP AUDITS

 

We offer the required high-quality GxP compliance audits:

  • Good Manufacturing Practice of manufacturers of active substances, excipients and finished medicinal products, as well as of manufacturers of primary and secondary packaging materials worldwide.
  • Good Distribution Practice of logistic operators, warehouses, distributors & transportation agencies.
  • Our Pharmacovigilance team has the knowledge and experience required for executing audits to Pharmacovigilance systems, commercial partners/distributors, subsidiaries, ensuring compliance of the Pharmacovigilance Good Practices.

PREPARATION

Pre-audit questionnaire
Costumised audit agenda
Pre-audit queries
Auditor’s solid CV
ON-SITE AUDIT
Audit performance
Audit report (quality system & facilities) and findings list
GAP analysis
CAPA plan
Re-audits uponplan

GMPs & GDPs

AGENCY INSPECTION TRIGGER

  • Dossier submission
  • Inspection slot request
  • On-site support during inspection

                          GVPs

  • Compliance with PV system mandatory audits
  • Creation of risk-based audit programmes
  • Preparation support for agency-triggered inspections