Audits
The compliance with the current regulations is an essential aspect to obtain authorisations and to market products.
Compliance with current regulations is essential for obtaining authorizations and marketing products. Regular verification of compliance with applicable legislation and standards ensures product safety and quality, enabling proper regulatory conformity, limiting future issues, and often reducing regulatory time and costs.
Di Renzo Regulatory Affairs has a dedicated unit including qualified experts fully committed to auditing and inspecting activities in all the sectors reported below.
Auditing activities are carried out based on the applicable regulations, including Good Manufacturing Practice (GMP), Good Pharmacovigilance Practice (GVP), Good Distribution Practice (GDP), Farmindustria Guidelines on Scientific Information, UNI CEI EN ISO 13485, UNI EN ISO 9001, UNI EN ISO 22716, HACCP etc.
Quality
- ISO 9001 audits
Medicinal Products
- GMP audits to finished product and active pharmaceutical ingredients (APIs) manufacturing sites, in Italy and in EU and extra-EU countries
- Audits to MA holders, “Concessionari di vendita”, warehouses, wholesalers of medicinal products
- Audits to MA holders for the Farmaindustria certification on the scientific information guidelines
- GVP audits in pharmacovigilance to MA holders, pharmacovigilance Providers, Distributors, “Concessionari di vendita”, Manufacturers and other Partners.
Medical Devices
- UNI CEI EN ISO 13485 audits
- Audits to Manufacturers, Warehouses, Distributors, Wholesalers
Cosmetics
- UNI CEI EN ISO 22716 audits
- Audits to Companies and suppliers of cosmetics or ingredients
- Audits to Warehouses, Distributors, Wholesalers
PMCs and Biocides
- Audits to Companies and suppliers of PMCs and/or biocides
- Audits to Warehouses, Distributors, Wholesalers
Food Supplements
- HACCP audits
- Audits to Companies and suppliers of food supplements and food for special medical purposes
- Audits to Warehouses, Distributors, Wholesalers