China NMPA Drug Inspection - Qianjiang Baozhentang Pharmacy - Sophora tonkinensis

The Hubei Province Drug Quality Bulletin (Issue 4, 2016), published on March 22, 2017, details findings from comprehensive drug quality sampling inspections conducted across various pharmaceutical production, operation, and use units in Hubei Province during the fourth quarter of 2016. A total of 144 drug batches were identified as non-compliant with established standards.

Main violations encompassed traditional Chinese medicinal herbs (processed pieces), medical institution preparations, and other pharmaceutical preparations. Common issues included failures in properties, identification (e.g., microscopic characteristics, thin-layer chromatography), and examination for impurities like sulfur dioxide residue, total ash, and moisture content. A significant and recurrent problem identified was product authenticity, with numerous instances where the indicated manufacturer denied production, could not be verified, or had their production license revoked, highlighting severe supply chain integrity concerns.

Regulatory assessments were based on the Chinese Pharmacopoeia (2010 and 2015 editions), Hubei Provincial Standards for Traditional Chinese Medicine Quality, and various national and Ministry of Health drug standards. Required actions include thorough investigations by local food and drug administration departments, increased follow-up sampling, tracing the source of non-compliant products, and referring suspected criminal cases to public security organs for prosecution, underscoring a commitment to reinforcing drug quality and supply chain control.