Main findings were as follows:

1. Ossotide injection

(1) The company bought 7 batches of foreleg bone from XX Co. Ltd., but failed to conduct procurement and acceptance inspection according to stipulations. The company failed to formulate procurement order according to procurement SOP. After the arrival of materials, the company failed to request and check the inspection report issued by the supplier in accordance with the SOP for the acceptance inspection, warehousing and storage of materials; for the acceptance inspection, the company failed to request temperature monitoring record of cold chain transportation of pig legs.

(2) The virus inactivation for the stock solution of compound ossotide was not validated; there was validation data to support that the four pig legs shall be stored for 25 days after requisition and the time from filling to sterilization initiation of compound ossotide injection is five hours; the time from the end of preparation to the end of the filling of compound ossotide injection was 10 hours, which lacked the microbial limit detection data.

(3) The continuous stability test scheme failed to set and inspect such activity indicators and related safety indicators as allergic experiment, pyrogen, and abnormal toxicity.

2. Fructose diphosphate injection

(1) The criteria for microbial limit in internal control standard of fructose diphosphate manufacturers failed to be revised in accordance with corresponding provisions in Chinese pharmacopoeia (2015 edition).

(2) For the compound enzyme reagent used for the content determination of the APIs of fructose diphosphate, the expiration date was December 2015. It was found in on-site inspection that the enterprise still used such enzyme reagent to conduct content determination of 14 batches of APIs of fructose diphosphate after the expiration date.

3. Citicoline sodium injection

(1) The inner quality standard for the APIs of citicoline sodium was unreasonably developed, and the item of toluene residue was not added with reference to the quality standard of APIs manufacturers.

(2) For the comparison of the content determination methods of intermediates and finished products of citicoline sodium injection, it was conducted only for the detection result of one batch and was not representative.

(3) The enterprise of citicoline sodium injection failed to conduct process validation for the APIs of different manufacturers respectively; the enterprise failed to provide compatibility test data of sterilizing filter for citicoline sodium injection.

Part IV Unannounced Inspection for Pharmaceuticals

　　I. Overview of Inspection

　　In accordance with the requirements for relevant departments of CFDA, based on the Working Procedure for Unannounced Inspection on Pharmaceutical GMP, a total of 45 unannounced inspection tasks from CFDA have been received in 2016, of which 39 unannounced inspections on Pharmaceutical GMP have been completed with the results reported, and others are on-going. The 39 inspections with the results reported involved 20 provinces (municipalities) including Beijing, Jiangsu and Guangdong etc., and covered 9 manufacturers of biochemical drugs, 20 manufacturers of TCMs, 9 manufacturers of chemicals and 1 manufacturer of blood product. The distribution was as follows:

Of the unannounced inspection tasks in 2016, 33 tasks were from the Department of Drug and Cosmetics Supervision of CFDA, and 6 tasks were from the Department of Drug and Cosmetics Registration and other departments of CFDA. The tasks from the Department of Drug and Cosmetics Supervision of CFDA accounted for 85%, which was the main source of unannounced inspection tasks. Among 39 unannounced inspections, the inspections on TCMs accounted for 51% of all the unannounced inspection work while that on chemicals and biochemical drugs accounted for 23%, respectively. In the unannounced inspection in 2016, 21 drug manufacturers failed, accounting for 54%. It was suggested to revoke the pharmaceutical GMP certificate of 14 enterprises and to open an investigation for 10 enterprises. The problematic products of 7 enterprises were ordered to be recalled. In pharmaceutical GMP unannounced inspection, TCMs and chemical drugs were identified to have more problems. All issues found in unannounced inspection have been dealt in accordance with the law.