1.The manufacturer shall establish and maintain a quality control system under the authority of a person who has the requisite qualifications and is independent of production.
That person shall have access to one or more quality control laboratories appropriately staffed and equipped to carry out the examination and testing of starting materials and packaging materials and the testing of intermediate and finished investigational medicinal products.
2.The manufacturer shall ensure that the quality control laboratories comply with information provided in the application dossier, referred to in Article 25(1) of Regulation (EU) No 536/2014, as authorised by Member States.
3.When investigational medicinal products are imported from third countries, analytical control in the Union shall not be mandatory.
4.During the final control of the finished investigational medicinal product, and before its release by the manufacturer, the manufacturer shall take into account:
(a)analytical results;
(b)production conditions;
(c)the results of in-process controls;
(d)the examination of the manufacturing documents;
(e)the conformity of the product with its specifications;
(f)conformity of the product with the clinical trial authorisation;
(g)examination of the final finished packaging.