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

Source: https://www.globalkeysolutions.net/records/china_inspection/guizhou-deliangfang-pharmaceutical-co-ltd/d3f86721-b408-4554-8b62-34bad0abb3e8/
Source feed: China

> China NMPA unannounced inspection for Guizhou Deliangfang Pharmaceutical Co., Ltd. published December 05, 2018. Guizhou Deliangfang Pharmaceutical Co., Ltd. underwent an unannounced extended inspection by China's State Food and Drug Administration, with findings

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Guizhou Deliangfang Pharmaceutical Co., Ltd.
- Company Name: Guizhou Deliangfang Pharmaceutical Co., Ltd.
- Publication Date: 2018-12-05
- Product Type: Drugs
- Summary: Guizhou Deliangfang Pharmaceutical Co., Ltd. underwent an unannounced extended inspection by China's State Food and Drug Administration, with findings published on November 30, 2018. The inspection revealed critical non-compliance with drug manufacturing regulations, particularly the Good Manufacturing Practice for Pharmaceuticals (2010 Revision).

Major violations included the inadequate safety management of special drugs, such as poppy shells and ephedra. The company's computerized systems were significantly deficient, with analytical instruments lacking audit trails, insecure HPLC workstations without proper access controls, and an absence of QA login accounts. Quality Control and Assurance exhibited widespread failures, including missing raw material spectra, inadequate HPLC system suitability testing, unapproved manual data integration, and outdated Standard Operating Procedures (SOPs) not updated to the 2015 Pharmacopoeia requirements. Laboratory records were incomplete, equipment maintenance was deficient, and stability samples were stored improperly. Crucially, the company lacked essential deviation, OOS (Out-of-Specification), and CAPA (Corrective and Preventive Action) reporting systems.

Furthermore, validation processes were insufficient; cleaning validation for shared equipment failed to address cross-contamination risks from contract manufactured products containing special ingredients. Data reliability was compromised by missing microscopic identification records, untrained personnel, and discrepancies in reference material batch numbers. As a result of these severe deficiencies, the Guizhou Provincial Drug Administration was directed to revoke the company's GMP certificates and initiate further investigations.

Company: https://www.globalkeysolutions.net/companies/guizhou-deliangfang-pharmaceutical-co-ltd/72c2384e-2521-4a86-87b4-7e483974ff31/