EMA adopts biotechnology-derived active substances process validation guideline
The goal of process characterisation is to design a process that can consistently deliver an active substance that meets its quality attributes
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a guideline for the process validation (the documented evidence that the process, operated within established parameters, can perform effectively) for the manufacture of biotechnology-derived active substances.
The text also covers the data requirements for process characterisation (the definition of the commercial manufacturing process that will be reflected in planned master production and control records).
A listing of the data to be provided in the regulatory submission has also been adopted. This is the final step in a process which began two years ago and included a public consultation. The guideline will come into effect on 1 November.
The EMA explained that process validation 'can be performed in a traditional way regardless of the approach to development taken'.
The guideline allows for the possibility of implementing continuous process verification 'if an enhanced approach to development has been performed or where a substantial amount of product and process knowledge and understanding has been gained through historical data and manufacturing experience.'
Process validation should not be viewed as a one-time event, said the Agency.
It incorporated a 'lifecycle approach linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production'.
The goal of process characterisation was to design a process 'suitable for routine commercial manufacturing that can consistently deliver an active substance that meets its quality attributes,' it said.