2. Failure to have adequate written procedures for the receipt, identification, quarantine, storage, sampling, testing, handling, and approval or rejection of raw materials.I keep a lot of stuff in my head, but I try to write it down as soon as I can.
For example, when our investigator asked for a list of your critical raw materials and your sampling requirements, you told our investigator that you had no written procedures for testing and sampling incoming materials. Instead, you explained, your warehouse employees accounted for incoming raw material handling, sampling, and testing “in their heads.”
4. Failure to prepare adequate batch production records and record the activities at the time they are performed.
For example, our investigator found that your operator used process parameter values from previous batches of [redacted] to complete new batch records when she was too tired to immediately record the data and had forgotten the values.
Wednesday, May 24, 2017
Warning Letter of the Week: "in their heads" edition
Via an irritated note from the Center for Drug Evaluation and Research to the general manager of Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory, Mr. Zheng Goubin, this terribly amusing comment: