China NMPA Inspection - Shanghai Qingping Pharmaceutical Co., Ltd. - June 07, 2016

An unannounced inspection of Shanghai Qingping Pharmaceutical Co., Ltd., conducted by the National Food and Drug Administration Food and Drug Inspection and Testing Center from April 23-25, 2016, revealed serious deficiencies in compliance with pharmaceutical Good Manufacturing Practice (GMP) standards. Key violations included significant issues with the reliability of laboratory data. Inspectors found evidence of altered testing dates in laboratory logs, specifically with a Shimadzu LC-10AT system, affecting stability studies and precision tests. Additionally, unexplained deletions of chromatograms were observed in a Shimadzu LC-20AT system during tests for related substances and cleaning validation. Furthermore, the inspection identified inadequate measures for controlling pollution and cross-contamination during production. Deficiencies included a lack of clear labeling on material collection bags, absence of anterooms and effective dust collection in dust-generating areas like weighing and tableting rooms, and non-specific cleaning procedures for equipment such as V-type mixers. Residue was also found on production equipment due to insufficient cleaning. As a result, the company's production and quality management were deemed non-compliant with the "Good Manufacturing Practice for Pharmaceuticals" (2010 revision). The regulatory authority mandated that the Shanghai Municipal Food and Drug Administration revoke the company's tablet GMP certificate. Shanghai Qingping Pharmaceutical Co., Ltd. is also required to conduct a thorough risk assessment for dibazol tablets and implement immediate risk control measures to address the identified problems.