FDA EIR - Shandong Qilu King-phar Pharmaceutical Co., Ltd. - August 04, 2011

A Current Good Manufacturing Practice (CGMP) and pre-approval inspection was conducted at Shandong Qilu King-Phar Pharmaceuticals in Jinan, China, from August 1-4, 2011. The inspection, requested by the Center for Veterinary Medicine, focused on the company's manufacturing of non-sterile Active Pharmaceutical Ingredients (APIs) intended for use in sterile drug products. The regulatory framework for this assessment included FDA Compliance Programs and the ICH Q7 Good Manufacturing Practice Guidance for APIs, assessing systems like quality, facilities, materials, production, and laboratory controls.The inspection identified three main observations on an FDA-483 form. Firstly, the purified water used in critical API processing steps, particularly for products destined for sterile use, was not monitored or controlled for endotoxins. Secondly, the equipment cleaning and sanitation validation studies for these APIs did not include endotoxin contamination assessments. Lastly, the laboratory control system lacked proper monitoring and recording of temperatures for working standards and test organisms stored in freezers.Management, including General Manager Mr. Liu Shujiang and Quality Director Mr. Ding Xinren, acknowledged the findings. They committed to implementing corrective actions, which included initiating endotoxin monitoring for purified water and in cleaning validation studies, and establishing temperature monitoring for laboratory freezers. The company submitted a written response to the FDA-483, which was deemed adequate, with verification planned for a future inspection.