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.
Customised audit agenda
Audit report (quality system & facilities) and findings list
Re-audits upon plan
GMPs & GDPs
AGENCY INSPECTION TRIGGER
- Dossier submission
- Inspection slot request
- On-site support during inspection
- Compliance with PV system mandatory audits
- Creation of risk-based audit programmes
- Preparation support for agency-triggered inspections