Commission Directive (EU) 2017/1572Show full title

Article 11 Quality control

1. The manufacturer shall be obliged to establish and maintain a quality control system placed under the authority of a person who has the requisite qualifications and is independent of production.

That person shall have at his disposal, or shall have access to, one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of starting materials and packaging materials and the testing of intermediate and finished medicinal products.

2. For medicinal products, including those imported from third countries, contract laboratories may be used if authorised in accordance with Article 12 of this Directive and point (b) of Article 20 of Directive 2001/83/EC.

3. During the final control of the finished medicinal product before its release for sale or distribution, the quality control system shall take into account, in addition to analytical results, essential information such as the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the product to its specifications, including the final finished pack.

4. Samples of each batch of finished medicinal product shall be retained for at least 1 year after the expiry date.

Samples of starting materials, other than solvents, gases or water, used in the manufacturing process shall be retained for at least 2 years after the release of the product. That period may be shortened if the period of stability of the material, as indicated in the relevant specification, is shorter. All those samples shall be maintained at the disposal of the competent authorities.

Other conditions may be defined, by agreement with the competent authority, for the sampling and retaining of starting materials and certain products manufactured individually or in small quantities, or when their storage could raise special problems.