Regulation 39

must ensure, and maintain objective evidence to establish, that the manufacture of the CTGT product complies with the following standards:

in the case of a known manufacturer — Good Tissue Practice;

in the case of a licensed manufacturer — 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 those stages of the manufacture of the CTGT product that are undertaken by the manufacturer;

must not carry out any stages of manufacture of the CTGT product in any premises that are not specified premises;

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

must only use the specified premises, or any other premises that the Authority approves, for handling or storing the CTGT product;

must carry out, or arrange for a testing laboratory to carry out, tests on the strength, quality and purity of the CTGT product to ensure that the standards of the CTGT product comply with any applicable standard set by the Authority for the CTGT product;

must conduct all manufacturing operations in such a way as to ensure that the CTGT product is of the correct identity and conforms with the applicable standards of strength, quality and purity; and

must ensure that any tests for determining conformity with the applicable standards and specifications applying to the CTGT product are, unless otherwise provided in the licence, applied to samples taken after all manufacturing processes have been completed, or at any earlier stage in the manufacture that the Authority approves.

in the case of a known manufacturer — a testing laboratory determined by the known manufacturer; or

in the case of a licensed manufacturer — the testing laboratory specified in the licence.