21 CFR 211.188 - Batch production and control records.
Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. These records shall include:
(a) An accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed;
(b) Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including:
(7) A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing;
(11) Identification of the persons performing and directly supervising or checking each significant step in the operation, or if a significant step in the operation is performed by automated equipment under § 211.68, the identification of the person checking the significant step performed by the automated equipment.
(12) Any investigation made according to § 211.192.
(13) Results of examinations made in accordance with § 211.134.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51933, Sept. 8, 2008]
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.