Quality should have a significant role not only for clinical production but also for all development activities. Accurate documentation during process development simplifies the transfer and implementation of the process in collaboration with the manufacturing facility. It is also important in support of regulatory activities.
Rodon operate according to their internal system including quality manuals and SOPs. It is the responsibility of all personnel at Rodon to work to those standards and assure reliable results, accurate documentation and traceable records for all work carried out.
Key equipment is routinely calibrated and maintained according to a defined schedule. Raw materials are obtained through recognised suppliers and traceability assured via a lot number system for raw materials, reagent stocks and processes operated using those raw materials and stocks.
All work will be accurately recorded in compliance with internal standards and all reports will be reviewed before release.