Minakem considers quality a priority and a major focus in terms of process, human resources and equipment.
Minakem operates under strict GMP conditions and commits to.
- Maintain the compliance of the quality system
- Make quality the responsibility of all employees and staff
- Ensure customer satisfaction
- Focus on continuous improvement
- In addition, and on demand, Minakem can provide other regulatory support such as (but not restricted to):
- writing DMF’s
- establishing European Conformity Certificates (ECC’s)
Minakem is fully compliant with international regulation, industry quality standards, manufacturing practices and safety and health and environment protection legislation.
- EHS Compliance & cGMP (ICHQ7A) Compliance
- Frequently inspected (authorities & customers)
- ISO14001 certified (2006 – 2015)
- US cGMP certified
- European GMP 1 and 2 certified
Since the beginning of Minakem’s API production activities, our facilities have a long and successful track record of inspection by health authorities and client audits.
Our general policy is to provide our clients with full supporting documentation for their business to be a success. Our Quality Assurance system is built in order to validate that Minakem will reach its goal as an organization fully dedicated to complete client satisfaction.