NAC585.590. Records of batches.

     1. A licensee shall prepare a record containing complete information concerning the production and control of each batch of a drug which the licensee produces. He or she shall retain the record for at least 2 years after the distribution of the batch is complete or at least 1 year after the expiration date of the batch, whichever period is longer. The record must identify the specific labeling and lot numbers used on the batch and must be readily available during the retention period.

     2. The record must include:

     (a) An accurate reproduction of the appropriate master formula. The reproduction must be checked, dated and signed or initialed by a competent and responsible person.

     (b) An entry for each significant step in the manufacturing, processing, packaging, labeling, testing and controlling of the batch, including:

          (1) The date;

          (2) The major equipment and lines employed;

          (3) The specific identification of each batch of components used;

          (4) The weights and measures of components and products used in processing;

          (5) In-process and laboratory control results; and

          (6) The identification of the person who actively performs and who directly supervises or checks that step in the operation.

     3. A batch number that identifies all the production and control documents relating to the history of the batch and all lot numbers associated with the batch.

     4. A record of any investigation made pursuant to NAC 585.520.

     [Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 6.2-6.3.4, eff. 5-15-78]