# China NMPA Inspection - Guizhou Deliangfang Baishite Pharmaceutical Co., Ltd. - December 05, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/guizhou-deliangfang-baishite-pharmaceutical-co-ltd/417a34cc-efc1-4179-b088-991c46b9a9dd/
Source feed: China

> China NMPA unannounced inspection for Guizhou Deliangfang Baishite Pharmaceutical Co., Ltd. published December 05, 2018. An unannounced inspection by the National Food and Drug Administration Inspection Center and Guiyang Municipal Food and Drug Administration identified

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## Details

- Record Type: CHINA_INSPECTION
- Title: Follow-up Inspection Report on Guizhou Deliangfang Baishite Pharmaceutical Co., Ltd.
- Company Name: Guizhou Deliangfang Baishite Pharmaceutical Co., Ltd.
- Publication Date: 2018-12-05
- Product Type: Drugs
- Summary: An unannounced inspection by the National Food and Drug Administration Inspection Center and Guiyang Municipal Food and Drug Administration identified significant deficiencies at Guizhou Deliangfang Baishite Pharmaceutical Co., Ltd. The inspection, conducted under the National Medical Products Administration's drug tracking plan, uncovered issues primarily in three areas, with findings published on November 30, 2018. Firstly, the company's safety management of special drugs failed to meet regulatory requirements. Secondly, the quality control laboratory demonstrated unstandardized practices, including the absence of UV spectral data and sample preparation records for raw materials, lack of UV spectrophotometer calibration records and data export functionality, and the omission of system suitability tests for HPLC determination. Manual integration in content determination lacked proper approval and SOP specification. Lastly, the company's computerized systems were found to be non-compliant. Standalone analytical instruments, such as UV spectrophotometers and HPLCs, lacked essential audit trail functionality. The HPLC workstation exhibited weaknesses like the absence of user login, hierarchical access controls, and enabled system functions allowing data manipulation, alongside an unlocked system time. The system also lacked a dedicated login for Quality Assurance personnel. Additionally, general deficiencies were noted concerning organization, personnel, validation, and contract manufacturing. Due to the severity of these findings and the company's prolonged shutdown, the Guizhou Provincial Drug Administration has been directed to supervise the company, ensuring no resumption of production until all rectifications are fully completed.

Company: https://www.globalkeysolutions.net/companies/guizhou-deliangfang-baishite-pharmaceutical-co-ltd/ae95e9cc-f229-43fb-82b2-fa79fe38ee20/