A customer required a second source for a topical therapeutic with a nanoparticle component. A Manufacturing Master Record (MMR) and Manufacturing Batch Records (MBRs) were provided to nanoComposix for all intermediates, and the synthesis of the nanoparticle component was replicated at nanoComposix.
A Quality Plan was developed, the MMR and MBRs were transferred and adapted into our QMS, and engineering runs were performed using draft batch records. Additional test methods were developed and validated. New raw material suppliers were qualified. A cGMP-compliant qualification batch was produced and the material delivered to the customer.
NanoComposix passed a customer audit for adherence to QSR/ISO 13485 for the component manufacture, and nanoComposix was approved as a second source for supply of the GMP- manufactured nanomaterial.