La. Admin. Code tit. 51 § VI-1533
Current through Register Vol. 50, No. 11, November 20, 2024
Section VI-1533 - Records and Reports [formerly paragraph 6:209-1]A. To assure uniformity from batch to batch, a master production and control record for each drug product and each batch size of drug product shall be independently checked, reconciled, dated and signed or initialed by a second. The master production and control record shall include: 1. [formerly paragraph 6:209-1 (1)] the name of the product, description of the dosage form and a specimen of the copy of each label and all other labeling associated with the retail or bulk unit, including copies of such labeling signed or initialized and dated by the person or persons responsible for the approval of such labeling;2. [formerly paragraph 6:209-1 (2)] the name and weight or measure of each active ingredient per dosage unit, or per unit of weight or measure of the finished drug, and statement of the total weight or measure of any dosage unit;3.a. [formerly paragraph 6:209-1 (3)] a complete list of ingredients designated by names or codes to indicate any special quality characteristic;b. an accurate statement of the weight or measure of each ingredient, regardless of whether it appears in the finished product. Reasonable variations may be permitted in the amount of components necessary in the preparation in dosage form, provided that provisions for such variations are included in the master production and control record;c. a statement of theoretical weight or measure at various stages of processing and a statement of theoretical yield;4. [formerly paragraph 6:209-1 (4)] a description of the containers, closures and packaging and finishing materials;5. [formerly paragraph 6:209-1 (5)] manufacturing and control instructions, procedures and specifications, special notations and precautions to be followed.B. The batch production and control record shall be prepared for each batch of drug produced and shall include complete information relating to the production and control of each batch. These records shall be retained for at least two years after the batch distribution is complete or at least one year after the batch expiration date, whichever is longer. These records shall identify the specific labeling and lot or control numbers used on the batch, and shall be readily available during such retention period. The batch record shall include: 1. [formerly paragraph 6:209-2 (1)] an accurate reproduction of the master formula record checked, dated and signed or initialed by a person responsible for the approval of this record;2. [formerly paragraph 6:209-2 (2)] a record of each step in the manufacturing, processing, packaging, labeling, testing and controlling of the batch, including dates, individual major equipment and lines employed, specific identification of each batch of components used, weights and measures of components and products used in the course of processing, in-process and laboratory control results and identification and checking each significant step in the operation;3. [formerly paragraph 6: 209-2 (3)] a batch number that identifies all the production and control documents relating to the history of the batch and all lot and control numbers associated with the batch;4. [formerly paragraph 6:209-2 (4)] a record of any investigation made according to §1533 ALa. Admin. Code tit. 51, § VI-1533
Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1256 (June 2002).AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:601 et seq.