Regulation 26

must ensure, and maintain objective evidence to establish, that the manufacture of the active ingredient complies with the Good Manufacturing Practice standard;

must provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities that are necessary for carrying out, in accordance with the holder’s licence, the stages of the manufacture of the active ingredient that are undertaken by the holder;

must not carry out any stage of manufacture of the active ingredient in any premises not specified in the holder’s licence;

must provide and maintain, or ensure the provision and maintenance of, the staff, premises, equipment and facilities for the proper handling and storage of the active ingredient that are necessary to prevent the deterioration of the active ingredient while it is in the holder’s ownership, possession or control;

must only use the premises specified in the holder’s licence, or any other premises that may be approved from time to time by the Authority, for handling or storing the active ingredient;

must carry out, or arrange for a testing laboratory as specified in the licence to carry out, tests on the quality and purity of the active ingredient to ensure that the standards of the active ingredient comply with any applicable standard set by the Authority for the active ingredient; and

must conduct all manufacturing operations in such a way as to ensure that the active ingredient is of the correct identity and conforms with the applicable standards of quality and purity for that active ingredient.