Hong Kong Regulations

PHARMACY AND POISONS REGULATIONS - REGULATION 35

Records to be kept by manufacturers

(1) A manufacturer shall maintain adequate records in respect of each
pharmaceutical product prepared by him, showing-

   (a)  the quantities of all substances used in the manufacture of the
        product;

   (b)  the quantity of the product manufactured;

   (c)  the name and the address of the person to whom the pharmaceutical
        product was sold or supplied;

   (d)  the nature and results of tests made on each lot or batch of raw or
        bulk materials used in the product;

   (e)  the nature and results of tests made on each batch of finished
        product;

   (f)  any complaints received relating to the product and the action taken
        thereon by him; and

   (g)  the nature and result of any tests made on the samples retained. (L.N.
        228 of 1975)

(2) The records required to be maintained by paragraph (1) shall be completed
within 72 hours from the time the process or test was carried out or the
transaction took place. (L.N. 137 of 1978)