Elevating patient safety and compliance: Euromed Pharma’s quality system excellence
Euromed Pharma ensures its quality standards are in full alignment with the latest regulatory requirements, adhering to the specific needs of our partner companies and the guidelines set by regulatory bodies. We are actively involved with the European Medicines Verification Organisation (EMVO) to support the development of the European Medicines Verification System (EMVS). This initiative aims to authenticate medicines and improve patient safety, following the guidelines of the Falsified Medicines Directive (FMD) and the Delegated Regulation (DR), which specify safety feature requirements.
Our commitment to quality and safety is further evidenced by the authorizations we’ve received from AIFA (Italian Medicines Agency), the Ministry of Health, local health authorities (ATS/ASL), and our compliance with ISO 9001:2015 and ISO 13485:2016 certifications. These credentials enable us to ensure that our company procedures consistently meet or exceed the standards of current Good Manufacturing Practices (cGMP) and current Good Distribution Practices (GDP).
Comprehensive quality management procedures at Euromed Pharma
From self-inspection to CAPA: a closer look at our quality assurance practices
Our procedures include:
- Self-inspection scheduling
- Management of deviations and CAPA (corrective actions and preventive actions)
- Audit to transport, goods and services partners
- Management of customer complaints
- Management of returned products
- HACCP system (for food requirements, including food supplements such as supplements)
- KPIs analysis (in this case an internal system of KPIs can easily be adapted to the KPIs requested by customers if there were specific parameters to be evaluated)
- Temperature monitoring of our warehouses and during the transport of medicines. Following the identification of the most critical routes (worst case approach), continuous monitoring plans are established annually on temperatures during transport up to the last mile
- Management of IT systems certified by GAMP 5, CRF 21 part 11 and Annex 11 GMP
- Management of staff training
- Product traceability and recall management
- Management of company changes
- Periodic management reviews
- Risk analysis management
- Business continuity plan
Comprehensive quality management procedures at Euromed Pharma
A collaborative approach with the Italian mint for bollini label integration
The role of Euromed Pharma in advancing medicinal traceability in Italy
Euromed Pharma, as a key player in the pharmaceutical industry, has developed a robust system for managing the Bollini labels with the Italian Mint (Istituto Poligrafico e Zecca dello Stato, IPZS), crucial for the Italian reimbursable system management. This initiative is part of a broader effort to ensure the traceability and authenticity of medicines throughout the entire distribution chain in Italy, from production or importation to delivery to the public.
Together throughout your drug’s lifecycle
Privacy Policy – Cookie Policy – Whistleblowing – Euromed Pharma a Petrone Group Company®