Congratulations to Soho-Yiming for passing the US FDA on-site inspection with on deficiency
Last Monday on June 6th Shanghai Soho-Yiming received the phone call from the US FDA office located in China, because the company’s products are export to the US market, FDA will hold a four-day factory inspection to Soho-Yiming tomorrow to ensure the hardware facilities and quality management system is conformed to FDA regulations.In the face of the sudden "flying inspection" challenge, the company's management briefly discussed and decided: welcome the inspection and create conditions for the company to further expand the high-end markets in Europe and America.From June 6th to 9th, with the company of related personnel, FDA inspector Christopher searched for every building, every room, every drawer and garbage can, even the non-GMP area. From the site to documents, from equipment to personnel, from verification to training, the deviation, change is repeated tracking to deconstruct everything.Facing the continuous four days inspection, all the staff in duty of Soho-Yiming answered question honestly and corporate with the inspection by the file record and daily requirements. On the 9th afternoon, at the conference after the inspection, everyone smiled happily when inspector Christopher said no deficiency, no letter483.As the core of factory’s quality management, the requirements of the GMP can be simplified as 12 words: “write what you will do, do what you’ve written, remember what you’ve done”. This may sound easy, however the requirements of these 12 words means high level management and massive daily work when facing complicated and dynamic production technical flow. The company owned brand new cGMP hardware environment after Soho-Yiming moving to the new base. The company also pay a lot attention on improvement of the level of management. As the saying goes, no pains, no gains. The company can pass the FDA on-site inspection with no deficiency for the first time, it’s no doubt that this is the best gift for Soho-Yiming’s GMP spirit. Professor Caohui of Center for Drug Evaluation in Shanghai as the inspector accompany with this inspection. Although the company passed the inspection successfully, but there is no best but only better for GMP work，Soho-Yiming still has lots of parts to be better and will continue to improve.