Each batch of a finished product must be certified by a Qualified Person within the EC/EEA before being released for sale or supply in the EC/EEA or for export. The purpose of controlling batch release in this way is:
- to ensure that a particular batch has been manufactured and checked in accordance with the requirements of its marketing authorization, the principles and guidelines of EC good manufacturing practice or the good manufacturing practice of a third country recognized as equivalent under a mutual recognition agreement or any other relevant legal requirement before it is placed on the market, and
- in the event that a defect needs to be investigated or a batch to be recalled, to ensure that the Qualified Person who certified the batch and the relevant records is readily identifiable.
VelaLabs has its own Qualified Person for batch release and additionally can perform most of the analytical methods and assays required for the release of biopharmaceuticals and biosimilars.