# China NMPA Inspection - Sichuan Gaoyuan Mingzhu Pharmaceutical Co., Ltd. - June 02, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/sichuan-gaoyuan-mingzhu-pharmaceutical-co-ltd/480e3a78-30cd-4e42-8934-6d1a9392ecbd/
Source feed: China

> China NMPA unannounced inspection for Sichuan Gaoyuan Mingzhu Pharmaceutical Co., Ltd. published June 02, 2017. An unannounced inspection of Sichuan Gaoyuan Mingzhu Pharmaceutical Co., Ltd. by Chinese regulatory authorities took place from December 9-11, 2016. T

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Sichuan Gaoyuan Mingzhu Pharmaceutical Co., Ltd.
- Company Name: Sichuan Gaoyuan Mingzhu Pharmaceutical Co., Ltd.
- Publication Date: 2017-06-02
- Product Type: Drugs
- Summary: An unannounced inspection of Sichuan Gaoyuan Mingzhu Pharmaceutical Co., Ltd. by Chinese regulatory authorities took place from December 9-11, 2016. The inspection uncovered serious deviations from the "Drug Administration Law of the People's Republic of China" and Good Manufacturing Practice (GMP) regulations. Major violations included extensive data integrity issues, such as the fabrication of process verification records and unauthorized manipulation of computer system timestamps on analytical equipment, alongside unrecorded deletion and inconsistency of analytical data. The company also failed to implement adequate change control for a significant increase in the production batch size of Compound Isatis Root Granules, neglecting risk assessments and process validation. Deficiencies in organizational management were observed, including an unregistered change in production leadership and unstandardized batch production order management. Furthermore, material management was severely inadequate, marked by pest presence, insufficient storage infrastructure, co-mingling of raw materials from different suppliers, and inaccuracies in inventory records and labeling. Inadequate cleaning procedures for production equipment presented risks of contamination and cross-contamination. Consequently, the State Food and Drug Administration has mandated the revocation of the company's GMP certificates, supervision of product recalls, and the initiation of an investigation into these illegal and irregular practices.

Company: https://www.globalkeysolutions.net/companies/sichuan-gaoyuan-mingzhu-pharmaceutical-co-ltd/07074ab9-dc15-4c05-a8af-fa119c56b862/