From April 24th to 26th, 2018, according to the "Administrative Measures for the Certification of Pharmaceutical Production Quality Standards", the Zhejiang Provincial Drug Certification and Inspection Center sent a special expert group to our company to carry out GMP recertification on-site inspection work. In the three-day period, the expert group will follow the new GMP inspection plan, through on-site inspection, document and data review, questioning, discussion and exchange, etc., from personnel and institutions, equipment, materials, hygiene, verification, documentation, production management, quality. Management, self-inspection and other aspects were checked one by one, and the relevant records were carefully reviewed.
In order to meet this certification, the company carried out various preparatory work one year ahead of schedule, and launched several self-examination and self-correction. At the inspection site, the relevant departments of the company closely cooperated with the work of the expert group, read the files, answered the questions, successfully completed the various work contents, and successfully passed the on-site inspection of the drug GMP certification!
In the final summary, the GMP inspection team affirmed the company's overall quality management system and proposed improvements to the deficiencies. Based on the opinions and suggestions of the experts, we also carried out some related rectifications to further improve the company's A quality management system that ensures the production of products that meet the intended use and registration requirements.
On-site inspection of pharmaceutical GMP certification is a major event for the sustainable development of the company. This re-certification is the second re-certification of our company after passing the GMP certification for the first time in June 2013. The successful GMP re-certification work proves that our company conducts raw materials procurement, product production and quality inspection in strict accordance with the relevant requirements of the GMP regulations and the Pharmaceutical Production Management Law. In the various work links, we will implement the corporate goal of “doing medicine with integrity and being a good person”. It marks that the quality and software level of our company's quality system has reached the new standards set by the state, which has won a more stable position for the company in the current fierce external competition, and has played a more qualitative role in the future sustainable production of our company.
In the future work, we will continue to improve the working methods, strengthen the refinement, standardization management, go all out, make persistent efforts, dedication to high-quality products, make good medicines with all our heart, and benefit the country and the people for development, for humanity. Health cause contributes a force!