China NMPA Drug Inspection - Yanbian University Caoxian Pharmaceutical Co., Ltd. - Five-dimensional lysine granules

The Jiangsu Province 2017 Issue 4 Drug Quality Bulletin, published by the Chinese National Medical Products Administration (NMPA) on December 26, 2017, detailed extensive quality control issues identified during inspections of various drug products and Traditional Chinese Medicine (TCM) materials. The inspections, covering products from 2015 to 2017, revealed non-compliance from numerous pharmaceutical manufacturers and TCM producers, including Jinzhou Hanbao Pharmaceutical, Hebei Yinengpu Pharmaceutical, Anhui Jinfurong Traditional Chinese Medicine Processed Slices, and Nanjing Municipal Hospital of Traditional Chinese Medicine, among many others.

Key violations spanned critical deficiencies in both finished drugs and raw materials. For chemical drugs, issues included inaccurate active ingredient content, inadequate dissolution rates, incorrect fill volumes, and unacceptable levels of related substances. TCM materials and processed herbs frequently failed standards for total ash content, extractives, appearance, moisture levels, and the presence of impurities or residues like sulfur dioxide. A significant finding was that several TCM manufacturers disclaimed products identified as non-compliant, indicating potential mislabeling or illicit manufacturing. Hospital preparations also exhibited quality concerns related to appearance and content uniformity.

These findings were evaluated against the stringent regulatory frameworks of the Chinese Pharmacopoeia (2010 and 2015 editions), national drug standards, Ministry of Health drug standards, and Jiangsu Province's specific processing standards for TCM. While the bulletin does not detail explicit enforcement actions, the widespread non-conformities necessitate manufacturers undertaking thorough investigations, implementing corrective and preventive actions, and potentially initiating product recalls to safeguard public health and ensure drug quality and efficacy.