S.L. 437.108 Art. 11Quality control.

(1) The manufacturer shall establish and maintain a quality control department:

Provided that this department shall be placed under the authority of a person having the required qualifications and shall be independent of the other departments.

(2) The quality control department shall have at its disposal one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of starting materials, packaging materials and intermediate and finished products testing:

Provided that, resorting to outside laboratories is authorized in accordance with rule 12 and after the authorization referred to in Article 24(b) of Directive 2001/82/EC has been granted.

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

(4) (a) Samples of each batch of finished products shall be retained for at least one year after the expiry date.

(b) Samples of starting materials other than solvents, gases and water used shall be retained for at least two years after the release of the product:

Provided that this period may be shortened if their stability, as mentioned in the relevant specification, is shorter.

(c) All the samples shall be maintained at the disposal of the competent authority.

(d) For certain veterinary medicinal products manufactured individually or in small quantities, or when their storage could raise special problems, other sampling and retaining conditions may be defined in agreement with the competent authority.