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:
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:
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.