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 the Pharmacovigilance system, commercial partners/distributors, subsidiaries, ensuring compliance of the Pharmacovigilance Good Practices.

First
PREPARATION

Pre-audit questionnaire

Customised audit agenda

Then

ON-SITE AUDIT

Audit performance

Audit report (quality system & facilities) and findings list

GAP analysis

CAPA plan

Re-audits upon plan

GMPs & GDPs

AGENCY INSPECTION TRIGGER