Title 21
SECTION 226.102
226.102 Master-formula and batch-production records.
§ 226.102 Master-formula and batch-production records.(a) For each Type A medicated article(s) master-formula records shall be prepared, endorsed, and dated by a competent and responsible individual and shall be independently checked, reconciled, endorsed, and dated by a second competent and responsible individual. The record shall include:
(1) The name of the Type A medicated article(s) and a specimen copy of its label.
(2) The weight or measure of each ingredient, adequately identified, to be used in manufacturing a stated weight of the Type A medicated article(s).
(3) A complete formula for each batch size, or of appropriate size in the case of continuous systems to be produced from the master-formula record, including a complete list of ingredients designated by names or codes sufficiently specific to indicate any special quality characteristics; an accurate statement of the weight or measure of each ingredient, except that reasonable variations may be permitted in the amount of ingredients necessary in the preparation of the Type A medicated article(s), provided that the variations are stated in the master formula; an appropriate statement concerning any calculated excess of an ingredient; and a statement of the theoretical yield.
(4) Manufacturing instructions for each type of Type A medicated article(s) produced on a batch or continuous operation basis, including mixing steps and mixing times that have been determined to yield an adequately mixed Type A medicated article(s); and in the case of Type A medicated article(s) produced by continuous production run, any additional manufacturing directions including, when indicated, the settings of equipment that have been determined to yield an adequately mixed Type A medicated article(s) of the specified formula.
(5) Control instructions, procedures, specifications, special notations, and precautions to be followed.
(b) A separate batch-production and control record shall be prepared for each batch or run of Type A medicated article(s) produced and shall be retained for at least 2 years after distribution by the manufacturer has been completed. The batch-production and control record shall include:
(1) Product identification, date of production, and endorsement by a competent and responsible individual.
(2) Records of each step in the manufacturing, packaging, labeling, and controlling of the batch, including dates, specific identification of drug components used, weights or measures of all components, laboratory-control results, mixing times, and the endorsements of the individual actively performing or the individual actively supervising or checking each step in the operation.
(3) A batch number that permits determination of all laboratory-control procedures and results on the batch and all lot or control numbers appearing on the labels of the Type A medicated article(s).