It is not possible in the present time to produce and sell APIs without a strong Quality Assurance (QA). Lab Ofichem works following the guidelines of Good Manufacturing Practices (GMP) and is certified since 2008. Lab Ofichem is also ISO 9001:2008 (since 2000) certified. The QA department keeps the ISO 9001:2008 and FAMI-QS (since 2008; formerly GMP+ since 2004) certification of Ofichem B.V. up to date.
Audit programLab Ofichem regularly gets audits from the Healthcare inspectorate (IGZ), VWA, clients and other bodies.
External Audit programRecently Ofichem B.V., Incopharm and Ofipharma offer the possibility of auditing API producers. These audits are performed by the QA Department. A qualified auditor will carry out the audit.
ContactWould you like to know more about our work methods? Or have you questions about the audit program? Please contact us.
The Regulatory Affairs department of the Ofichem Group is responsible for the certificate of suitability's (CEPs) and Active Substance Master Files (ASMFs).