What must a batch record contain?
A batch record (pumper’s log) must include documentation that each significant step in the manufacture, processing, packing, or holding of the batch has been accomplished. It must also include the identity of the person(s) performing and directly supervising each significant step. [21 CFR 211.188] 9. QUESTION: Must a firm produce a batch record for each batch of CMG filled and how long must it be retained? ANSWER: The firm must produce a batch record (pumper’s log) for every batch of CMG filled. This batch record and all other production and control records must be retained on file by the firm for at least one year after the expiration date of the batch. [21 CFR 211.180] 10.QUESTION: What if the person performing the significant step, such as vacuum evacuation of the cylinders, fails to indicate that the step was accomplished? ANSWER: The supervisor or person checking the batch record should determine if the step was accomplished and, if it was, require completion of the batch record.
