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.