Medicines and active substances manufactured or imported into the European Union must be manufactured in accordance with GMP standards and guidelines. And the distribution of these under GDP.
In Azierta, we carry out GMP/GDP Audits, to comply with the requirements set out in the GMP/GDP regulations and guarantee their compliance.
We ensure proper quality standards in the manufacturing process and the control of drugs, as well as in their distribution, both internally through customer and supplier audits.
We offer global support in audits from the deviations detected, follow-up of CAPAS until its closure.
Our service includes
- Scheduling, agenda planning and scope of audit.
- Execution of the Audit in the facilities.
- Elaboration of the final report with the detected observations.
- Review of the CAPA plan and closure of corrective actions.
We are specialists in GMP/GDP Quality Systems, we guarantee compliance with current regulations.