# China NMPA Inspection - Hubei Zhongjia Synthetic Pharmaceutical Co., Ltd. - August 31, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/hubei-zhongjia-synthetic-pharmaceutical-co-ltd/a47d71fd-7768-4128-8408-60ad9f8cb2c2/
Source feed: China

> China NMPA unannounced inspection for Hubei Zhongjia Synthetic Pharmaceutical Co., Ltd. published August 31, 2017. An unannounced inspection of Hubei Zhongjia Synthetic Pharmaceutical Co., Ltd. was conducted from July 21-23, 2017, by the State Food and Drug Adminis

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hubei Zhongjia Synthetic Pharmaceutical Co., Ltd.
- Company Name: Hubei Zhongjia Synthetic Pharmaceutical Co., Ltd.
- Publication Date: 2017-08-31
- Product Type: Drugs
- Summary: An unannounced inspection of Hubei Zhongjia Synthetic Pharmaceutical Co., Ltd. was conducted from July 21-23, 2017, by the State Food and Drug Administration. The inspection revealed serious deficiencies in the company's operations, leading to multiple violations of the Good Manufacturing Practice for Pharmaceuticals (2010 revision).

Key issues included a severely ineffective quality management system, characterized by insufficient quality assurance personnel and a single individual performing and checking critical QA tasks across multiple production batches. The company also failed to maintain records for deviations, out-of-specification results, or corrective actions. Significant facility changes were implemented without proper control, and no product quality reviews had been conducted for eleven batches of API since February 2015.

Material quality control was inadequate, with critical raw materials like n-propanol not fully tested according to registration standards. Recovered solvents lacked established quality standards and proper documentation. Inventory discrepancies were noted, and damaged raw material packaging went uninvestigated. Furthermore, key suppliers were not audited, and qualification files were missing.

Serious data reliability concerns were identified, including evidence of modified system times on high-performance liquid chromatographs (HPLC), the release of uncontrolled blank batch records, and a lack of hierarchical access control for analytical instruments.

As a consequence, the Hubei Provincial Food and Drug Administration was directed to revoke the company's GMP certificate, implement risk control measures on relevant drugs, and initiate an investigation.

Company: https://www.globalkeysolutions.net/companies/hubei-zhongjia-synthetic-pharmaceutical-co-ltd/ed53c47d-e791-4a60-8f64-4858ba6f33c8/