Global quality

A global Quality Compliance system implemented worldwide.

Esteve Química has evolved over the years from being a Spanish company with international business activities to a multi-national company with sites in three continents. Consequently, assuring the same level of compliance at all our premises has become an important task.

This led to the creation of the Global Compliance structure in 2009, which includes:

- Global Quality Assurance (QA) -in charge of SOP harmonization,

- Global Quality Compliance (QC) -supporting the guidelines related to QC labs, and

- Regulatory Affairs -which issues technical documentation with the local support needed to have our products approved by the authorities (FDA, EDQM, PMDA...). Currently active dossiers: 24 US DMFs (FDA), 15 CEPs (EDQM), 5 CAN DMFs (Health Canada), 6 J-DMFs (PMDA) and 1 C-DMF (CFDA).

Global quality
Global quality

The coordination of the compliance group and the Quality Units of the different manufacturing sites is addressed at the annual Global Quality meeting.

A Master Document named "Compliance Framework" was generated to establish the aspects that should be addressed at the different sites to ensure the same level of compliance. The current focus is placed on manufacturing change control, deviations, data integrity, and supply chain.

This Master Document is dynamic in nature and is reviewed and adapted at the annual Global Quality meeting.