# China NMPA Inspection - Tianjin Jinyao Group Hubei Tianyao Pharmaceutical Co., Ltd. - September 29, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/tianjin-jinyao-group-hubei-tianyao-pharmaceutical-co-ltd/618f7a2e-24a1-49f1-99e0-f0e8d2de19f4/
Source feed: China

> China NMPA unannounced inspection for Tianjin Jinyao Group Hubei Tianyao Pharmaceutical Co., Ltd. published September 29, 2016. Tianjin Jinyao Group Hubei Tianyao Pharmaceutical Co., Ltd. underwent an unannounced follow-up inspection by the State Food and Drug Administration an

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Tianjin Jinyao Group Hubei Tianyao Pharmaceutical Co., Ltd.
- Company Name: Tianjin Jinyao Group Hubei Tianyao Pharmaceutical Co., Ltd.
- Publication Date: 2016-09-29
- Product Type: Drugs
- Summary: Tianjin Jinyao Group Hubei Tianyao Pharmaceutical Co., Ltd. underwent an unannounced follow-up inspection by the State Food and Drug Administration and Hubei Provincial Food Food and Drug Administration from July 25-28, 2016. The inspection revealed significant violations of the "Drug Administration Law of the People's Republic of China" and Good Manufacturing Practice (GMP) regulations.

Key issues included the production of non-terminally sterilized products, specifically cytidine diphosphate choline sodium injection, on a production line certified only for terminally sterilized products. This operation lacked the necessary controls for personnel training, facility design, environmental monitoring, and aseptic assurance required for non-terminally sterilized items. Furthermore, process validation for this product was inconsistent with actual production batches and specifications, with some batches remaining unvalidated.

Significant data reliability concerns were identified, including instances of altered experimental times in high-performance liquid chromatograph logs, unrecorded deletion of analytical data, and a general lack of password management and user permissions for laboratory equipment. The inspection also found deficiencies in various validation activities, such as incomplete process validation for different ribavirin injection specifications across workshops, inadequate cleaning validation procedures, and a complete absence of computerized system validation for crucial analytical instruments.

As a result of these findings, the State Food and Drug Administration ordered the Hubei Provincial Food and Drug Administration to revoke the company's small-volume injection GMP certificate, initiate a thorough investigation, and implement comprehensive risk control measures for all affected products.

Company: https://www.globalkeysolutions.net/companies/tianjin-jinyao-group-hubei-tianyao-pharmaceutical-co-ltd/96f77f3b-e692-436b-a6a4-1860fa589885/