There must be a Technical Agreement and a recent audit of the company. If the company is supplying a finished drug product into the EU which needs a QP certification, a translation of one batch record as an example and a summary of each batch will be required together with a CoA. It is important that the QP can understand the process and whether there was any excursions/CAPA’s /changes etc. and what they were and how they were concluded. If this was a new company to the QP, and especially if supplying parenteral drugs, I would initially want an audit at least every 12 months until the relationship was fully established.
If the company is supplying APIs, the Technical Agreement and audit requirements and ability to understand any changes/excursions will still apply. I would also want to see a copy of the process flow document together with all the critical process parameters and be able to identify these comply on a batch to batch basis together with a CoA. The companies would also need to comply with all aspects of 2011/62/EU to the satisfaction of the QP and be accompanied by a written ation the competent authority of the exporting third ry which s that the standards of good manufacturing practice and control of the plant are equivalent to those in the EU (unless a waiver has been granted).
