Laboratory controls
Article 12
1. The manufacturer shall establish specifications for the quality and purity of the active substances he manufactures and for the raw materials, active substance starting materials and active substance intermediates used in that process. 2. Laboratory tests shall be conducted to verify compliance with the specifications referred to in paragraph 1. The manufacturer shall issue certificates of analysis for each batch of active substance upon the request of: (a) the competent authorities of a Member State; (b) manufacturers of active substances supplied directly or indirectly with the active substance for the purpose of further processing, packing, repacking, labelling or relabelling the active substance; (c) distributors and brokers of active substances; (d) manufacturers of medicinal products supplied directly or indirectly with the active substance. 3. The manufacturer shall monitor the stability of the active substance through stability studies. Dates for the expiry or retest of active substances shall be set on the basis of an evaluation of data derived from the stability studies. Appropriately identified samples of the active substance shall be retained in accordance with a sampling plan established on the basis of the shelf-life of the active substance.