Each batch of 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 the batch has been manufactured and checked in accordance with the requirements of its marketing authorisation, the principles and guidelines of EC Good Manufacturing Practice or the good manufacturing practice of a third country recognised as equivalent under a mutual recognition agreement and 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 recalled, to ensure that the Q.P. who certified the batch and the relevant records are readily identifiable.

Vela Labs has its own Qualified Person for Batch release - additionally Vela Labs can perform most of the analytical testings required for the release of Biopharmaceuticals.