偏差发生的直接原因是送样人员将检验报告单填写错误，根本原因是送样人员填

The direct cause of the deviation is that the sample sender filled in the inspection report form incorrectly. The root cause is that the sample sender did not pay attention when filling in the inspection report form (please check part) and mistyped the name of the test report form (please check part) . <br><br>This deviation involves three batches (1100-E190901, 1100-E190903, 1100-E191001) of the stability test report of the crude product of idarubicin hydrochloride (E process) (the name is wrong), the sample itself is not wrong, nor wrong. , The wrong name will not affect the crude quality, but it will cause a series of inconsistencies in GMP document information. <br><br>1. Three batches of standard revisions (1100-E190901, 1100-E190903, 1100-E191001) stability test report, sample label, IPC sample receiving account book, original test record, etc. of idarubicin hydrochloride (E process) crude products The name on the GMP file. And link the deviation number at the modification. <br>2. Conduct H3-VD-80054-P "Idarubicin Hydrochloride (E Process) Intermediate Stability Program" and H3-VD-50491-P-R01 "Idarubicin Hydrochloride (E Process) Process for the operator The training of "Verification Sampling Methods and Records" emphasizes that when samples are submitted for inspection, relevant documents should be consulted and the information requested should be carefully checked. <br>3. Taking this deviation as an example, train relevant personnel in workshop 205, emphasizing that if the trained personnel make similar mistakes within one year, they will be transferred from their posts.

The direct cause of deviation is that the sample person will fill in the inspection report form error, the root cause is that the sample person to fill out the inspection report form (please check part) when the attention is not concentrated, the inspection report form (please check part) of the name of the wrong. <br><br>This deviation involves three batches (1100-E190901, 1100-E100903, 1100-E191001) stability inspection list of the acrylic Idabistar (E process) crude product (name error), the sample itself did not get wrong, nor sent wrong, the name error will not have an impact on the quality of the crude product, but will cause a series of GMP file information inconsistent problems.<br><br>1. Standardize to modify the names of the GMP documents involved in the stability inspection report sheet, sample label, IPC sample receiving ledger, original test record, etc. of the three batches (1100-E190901, 1100-E100903, 1100-E191001) the crude productofs involved in the hydrochloric acid Idabistar (E process). And link the deviation number at the modified point.<br>2. Training of the operator sittivated H3-VD-80054-P "Idabistar (E Process) Intermediate Stability Scheme" and H3-VD-50491-P-R01 "Idabistar Hydrochloric Acid (E Process) Process Verification Sampling Method and Records" training, emphasizing that the relevant documents should be referred to when samples are sent for inspection and carefully check the verification information.<br>3. Take this deviation as a case, train the 205 workshop personnel, emphasizing that the trained personnel will be transferred from their posts if they make similar mistakes within one year.

The direct cause of the deviation is that the sample delivering personnel filled in the inspection report incorrectly. The root cause is that the sample delivering personnel did not pay attention when filling in the inspection report (inspection request part), and wrote the name of the inspection report (inspection request part) wrongly.<br>This deviation involves the stability inspection report (name error) of three batches of crude products (1100-e190901, 1100-e190903, 1100-e191001) of idabitin hydrochloride (e process). The sample itself has not been taken or sent wrong, and the name error will not affect the quality of crude products, but will cause a series of problems of inconsistent information in GMP documents.<br>1. Modify the name on GMP documents such as stability test report, sample label, IPC sample receiving account, original test record, etc. involved in three batches of crude products (1100-e190901, 1100-e190903, 1100-e191001) of idabixin hydrochloride (e process) in the specification. And link the deviation number where it is modified.<br>2. Train the operators on h3-vd-80054-p stability plan for intermediate of idabitin hydrochloride (e process) and h3-vd-50491-p-r01 sampling method and record for process validation of idabitin hydrochloride (e process). It is emphasized that relevant documents shall be referred to and inspection information shall be checked carefully when samples are submitted for inspection.<br>3. Take the deviation as an example, train the relevant personnel of workshop 205, and emphasize that if the trained personnel make similar mistakes within one year, they will be transferred from the post.<br>