On April 25, 2014, the EMA released a draft guideline on Process Validation for the Manufacture of Biotechnology-derived Active Substances and Data to be Provided in the Regulatory Submission. This document is intended to provide guidance on data which is expected to be included “in a regulatory submission to demonstrate that the manufacturing process described in the CTD section S.2.2 Description of manufacturing process and process controls consistently performs as intended.”
In order to obtain a marketable status for a product, one must first successfully validate the manufacturing process. “Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an active substance or intermediate meeting its predetermined specifications and quality attributes (ICH Q7).” In essence, process validation normally includes an evaluation that demonstrates each process step and the complete process is capable to perform as intended; furthermore, verification on commercial scale batches must show the process perform as intended. This process verification and evaluation is then included in the regulatory submission. It is also recommended to include data regarding process development within this submission. Process development is the basis for the final manufacturing process, which is to be validated; therefore, it plays a critical role in the development of criteria and conditions which are assessed during process validation studies.
This guidance applies to recombinant proteins and polypeptides, their derivatives, and products of which they are components to demonstrate that the active substance manufacturing process is in a validated state, but may also be helpful for other biological products such as vaccines or blood products.
Comments on the guidance can be submitted through the process described on the title page of the electronic guidance document linked here: