China NMPA Drug Inspection - Shanghai Xinyi Tianping Pharmaceutical Co., Ltd. - Beclomethasone dipropionate inhalation powder

The Jiangsu Province 2017 Issue 3 Drug Quality Bulletin, published on November 24, 2017, summarized findings from drug quality inspections across a diverse range of pharmaceutical products. Numerous companies, including Guizhou Tiandi Pharmaceutical, Shanghai Xinyi Tianping Pharmaceutical, and a significant number of Traditional Chinese Medicine (TCM) manufacturers predominantly located in Anhui and Jiangsu provinces, alongside Changshu Traditional Chinese Medicine Hospital, were identified for non-compliance. Inspections, reflecting products from 2016-2017 batches, uncovered various critical issues. Chemical drugs and antibiotics exhibited problems like visible foreign matter in Vitamin B6 Injection and microbial contamination in Beclomethasone Dipropionate Inhalation Powder. The extensive list of TCM materials and processed pieces showed widespread non-conformities, including deviations in appearance and properties, incorrect active ingredient content, excessive moisture or total ash, and unacceptable levels of sulfur dioxide residue. Hospital-prepared medications also demonstrated quality deficiencies, specifically concerning relative density, pH levels, and microbial counts. All products were evaluated against established regulatory frameworks, primarily the Chinese Pharmacopoeia (2015 and 2010 editions) and relevant provincial drug standards. The bulletin implicitly mandates that these manufacturers and hospital pharmacies must promptly address these significant quality control and manufacturing deficiencies to ensure product safety, efficacy, and adherence to national and provincial pharmaceutical standards.