# China NMPA Inspection - Bizhigao Pharmaceutical Co., Ltd. - December 05, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/bizhigao-pharmaceutical-co-ltd/c91bb713-438d-44da-958f-d06ea21f5d32/
Source feed: China

> China NMPA unannounced inspection for Bizhigao Pharmaceutical Co., Ltd. published December 05, 2018. An inspection of Bizhigao Pharmaceutical Co., Ltd., conducted under the State Food and Drug Administration's tracking plan, revealed significant non-c

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## Details

- Record Type: CHINA_INSPECTION
- Title: Comparison with the follow-up inspection report of Zhigao Pharmaceutical Co., Ltd.
- Company Name: Bizhigao Pharmaceutical Co., Ltd.
- Publication Date: 2018-12-05
- Product Type: Drugs
- Summary: An inspection of Bizhigao Pharmaceutical Co., Ltd., conducted under the State Food and Drug Administration's tracking plan, revealed significant non-compliance issues published on November 30, 2018. The company's production quality management, particularly for Jieyu Anshen Granules, failed to meet the Good Manufacturing Practice for Pharmaceuticals (2010 Revision).

Key violations included deficiencies in process validation. Specifically, re-validated batches with increased size lacked adequate quality assessment and stability testing. Additionally, the stipulated storage period for dry powder extract was unverified, with insufficient rectification efforts.

Serious concerns were also raised regarding data management and document control. Deleted critical data from a testing system was found, and the company failed to implement preventative measures. Electronic laboratory and quality assurance logs, stored in Word format, lacked proper access controls, leading to inconsistencies and blank records.

Furthermore, the processing of Chinese herbal medicine pieces exhibited shortcomings, including the absence of established procedures and batch sizes for prepared herbs. Production records for Polygala tenuifolia showed discrepancies compared to pharmacopoeia requirements. While new procedures were developed, their essential process validation remained incomplete.

Due to the company's failure to effectively rectify these deficiencies and prevent their recurrence, the Jilin Provincial Drug Administration has been directed to revoke Bizhigao Pharmaceutical Co., Ltd.'s relevant GMP certificates and initiate further investigation.

Company: https://www.globalkeysolutions.net/companies/bizhigao-pharmaceutical-co-ltd/298d0ec0-44bf-4fcc-b5d2-a0a7ae76b5f1/