News about GMP/cGMP


EMA: Process Validation for Biotechnology-derived APIs

The European Medicines Agency (EMA) has finalized a guidance that covers process validation including process characterization and process verification in the manufacture of biotechnology-derived active substances. This document provides guidance on the data to be included in a regulatory submission to demonstrate that the manufacturing process is in a validated state.


ICH Q7 defines process validation as, "The documented evidence that the process, operated within establish parameters, can perform effectively and reproducibly to produce an intermediate or API meeting its predetermined specifications and quality attributes."

The principles adopted and explained in the EMA document apply to recombinant proteins and recombinant polypeptides, their derivatives, and products of which they are components (e.g. conjugates).

Two areas of process validation are described in detail:

  • Process characterisation can be based on a traditional or enhanced approach to process development. Traditional and enhanced approaches are not mutually exclusive. The goal of this stage is to design a process suitable for routine commercial manufacturing that can constantly deliver an active substance that meets its quality attributes.
  • Process verification can be performed in a traditional way regardless of the approach to development taken. However, there is also the possibility to implement 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.

EMA points out, that process validation is not a one-time event and that process validation activities do not end at the time of the marketing authorization. It incorporates a lifecycle approach linking the following steps:

  • product and process development
  • validation of the commercial manufacturing process
  • maintenance of the process in a state of control during production.

Current experience shows that a company can use a traditional or an enhanced approach to process validation, or a combination of both. Regardless of the approach followed, the validation data to be included in the regulatory submission should cover information relating to the evaluation and the verification of the manufacturing process.

The 13-page guidance will be effective as of November 2016.


EMA guidance



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