Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 20

    For the purposes of section   40 of the Act, the following are conditions to which each licence is subject:

  (a)   a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;

  (b)   unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:

  (i)   keep records showing:

  (A)   the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and

  (B)   the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and

  (C)   details of the tests performed on the goods and the results of those tests; and

  (D)   the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and

  (ii)   where the goods to which the licence relates are produced in identifiable batches:

  (A)   assign a batch number to each batch of the goods; and

  (B)   if it is not unreasonable in the circumstances--retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and

  (iii)   retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and

  (iv)   ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control;

  (c)   the licence holder must comply with the provisions of Part   5 in relation to the taking of samples by authorised officers.