A GMP culture backed up with great SOP and well maintained and modern equipment is a good starting point for any complex RSM.
ICH Q7 states that an “API starting material” is a raw material, intermediate, or an API that is used in the production of an API.
Primopus follows ICH Q7 guidance regarding good manufacturing practices for the drug substances and intermediates it supplies.
We follow most of the critical GMP procedures to produce complex RSM’s. The synthesis steps prior to the RSM need not be GMP compliant; however, to guarantee that the RSM will not be a source of uncontrolled impurities, ensure a transparent supply chain and monitor any Critical Quality Attributes that that could affect the safety of the RSM and finally API to be used in a drug product.
At Primopus we operate a closed manufacturing concept which avoids the risks of cross contamination in the final stages of the RSM.
Primopus has rigorous procedures to monitor and control impurities.
If you are looking to bring your RSM manufacture closer to home, then please reach out to us so we can explore how we can best meet your requirements.