The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH). However, the QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP). The process of batch release comprises of:

• The checking of the manufacture and testing of the batch in accordance with defined release procedures.

• The certification of the finished product batch performed by a QP signifying that the batch is in compliance with GMP and the requirements of its MA. This represents the quality release of the batch.

• The transfer to saleable stock, and/or export of the finished batch of product which should take into account the certification performed by the QP. If this transfer is performed at a site other than that where certification takes place, then the arrangement should be documented in a written agreement between the sites.