Strict quality standards and certification or auditing guidelines exist in the pharmaceutical and healthcare industry.
At Aenova we are committed to high quality standards and have a track record of successful inspections by health authorities. We take special care to maintain and ensure all required standards at all of our sites to guarantee the highest product quality and product safety.
We build and live a culture of the highest quality requirements and continuous improvement, thus also ensuring the rapid implementation of new regulatory requirements, such as Annex 1, serialization, the Nitrosamine Regulation.
Approvals
Our sites have the following regulatory approvals
EU-GMP: 13 out of 14 sites
US FDA: 10 out of 14 sites
ANVISA: 8 out of 14 sites
As well as many other certifications and approvals such as: Swissmedic, GCC, NMPA, PMDA, APAC, MOH Russia and others.
Aenova Quality Management
To ensure rigorous production quality we have implemented a broad set of standards, processes and performance measures.
Aenova's own quality and regulatory management promotes internal standards for product quality and product safety at the highest level through
Constant monitoring
Proactive compliance
Harmonization and standardization
Digitization
Highly qualified employees
Qualified Persons
Constant facility and equipment maintenance
Validated processes and methods
Holistic and systematic quality management systems
Aenova Group