China NMPA Drug Inspection - Shizhentang Badong Pharmaceutical Co., Ltd. - alum

The "Jiangsu Province 2018, Issue 3 Drug Quality Bulletin," published on July 16, 2018, details findings of non-compliant drug products from various manufacturers. The regulatory framework for these assessments primarily included the Chinese Pharmacopoeia (2010 and 2015 editions), National Drug Standards, and specific provincial processing standards. Issues identified across numerous companies, such as Jiangxi Yaodu Renhe Pharmaceutical Co., Ltd., Jilin Yongli Pharmaceutical Co., Ltd., Shandong Jinqiao Pharmaceutical Co., Ltd., and Yaoshengtang (Hunan) Pharmaceutical Co., Ltd., encompassed a range of quality deviations.

Key violations included non-compliant appearance, lack of content uniformity, and failures in critical quality attributes like acid-insoluble ash, moisture content, identification tests (e.g., potassium/ammonium salt, Emodin), and accurate content determination. A significant number of non-compliances pertained to Traditional Chinese Medicinal materials and processed pieces, affecting products like Honeysuckle, Rhubarb, Alum, and various types of Lotus Seed. While specific required actions for each company are not detailed in this bulletin, such reports typically necessitate that manufacturers investigate root causes, implement corrective and preventive actions, and ensure their products meet established quality and safety standards to protect public health.