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Quality Assurance


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 program

Lab Ofichem regularly gets audits from the Healthcare inspectorate (IGZ), VWA, clients and other bodies.  

External Audit program

Recently 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.

Contact

Would you like to know more about our work methods? Or have you questions about the audit program? Please contact us.

Regulatory Affairs


The Regulatory Affairs department of the Ofichem Group is responsible for the certificate of suitability's (CEPs) and Active Substance Master Files (ASMFs).

Active Substance Master File

The Regulatory Affairs department ensures that all products have an up-to-date ASMF. This means that there is regular consultation with the QA. Any changes are reported directly to the clients and authorities.

Development of new products

In addition to the up keep of existing ASMFs, we are also developing new ASMFs. This takes place in cooperation with the research department.

Help and support with registrations

With years of experience in writing ASMFs we can help you with registrations. We can answer government questions and we can help you with the preparation of a registration, dossiers, etc.

Contact

If you are interested in what the Department of Regulatory Affairs can do for you, please contact us.