Chinese Antibiotic Manufacturer Cited for GMP Violations
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued to Inner Mongolia Changsheng Pharmaceutical, a Hohhot, China-headquartered pharmaceutical company, a statement of non-compliance with good manufacturing practice (GMPs) for active substances at its manufacturing facility in Tuoketuo, Hohhot, Inner Mongolia, China. The substance found to be non-compliant was amoxicillin trihydrate.
The statement was posted on EudraGMDP, a database of the European Medicines Agency providing information from the national regulatory authorities of the member states of the European Union, Iceland, Liechtenstein and Norway, on manufacturing and import authorizations, GMP certificates, statements of non-compliance with GMP, GMP inspection planning in third countries, and related information on good distribution practices.
The citations follow an October 2017 inspection. The company’s non-compliant manufacturing operations included manufacture of active substance by chemical synthesis, general finishing steps, and quality control testing.
One critical and eight major deficiencies were found. The critical deficiency related to the quality assurance system implemented on site, which was found to be weak and not capable of putting in place proper design, planning, implementation, maintenance, and continuous improvement of a system that allows the consistent delivery of products with appropriate quality attributes. Therefore, the report says a risk to the safety of patients could not be excluded. The MHRA says this was evidenced by the high number of major deficiencies observed in the following areas: deviation, management, storage, materials management, quality control, validation, qualification, complaint management, and documentation.
The MHRA said its inspection was the first Inspection carried out by an EU regulatory authority. The MHRA said in its report if there are alternative suppliers and there is no risk of shortage, recall of the medicinal product should be evaluated following assessment conducted in conjunction with marketing authorization holders. It said that given the nature of non-compliances, assessment should include a complete retest of all imported batches of active substance.
Source: European Medicines Agency