Assessment of each batch for certification prior to release may include batch records, QC data, associated records/quality systems, production conditions, cleaning records, examination of the finished packs, results of any importation testing where relevant, stability, shipping data, audits, documents certifying the authorisation of a manufacturer, relevant regulatory and GMP requirements, verification of the supply chain and all other factors the QP is aware of as relevant to the quality of the batch. The QP is responsible for ensuring that each individual batch of product has been manufactured and checked in compliance with laws in force in the UK or EU Member State where certification takes place, as applicable, in accordance with the requirements of Good Manufacturing Practice (GMP) and in compliance with the relevant marketing authorisation or clinical trial authorisation and product specification file, including clinical trial protocol, for a given product and associated trial.