The State Food and Drug Administration (SFDA) issued The Implementation Plan for a Special Nationwide Inspection of Drug Manufacturing on June 28, 2006 to implement the spirit of National Working Conference on Rectifying and Standardizing Drug Market Order and to ensure standardized drug manufacturing and drug quality.
The Implementation Plan requires that provincial drug regulatory departments carry out a full investigation of manufacturers of drug raw materials and drug preparations in their jurisdictions. The investigation should be concentrated on key issues to eliminate any risk factors. Manufacturers that produce injections, have been complained about their products, have products listed as substandard in Drug Quality Announcements in the past two years or have not undergone follow-up inspection or other inspections in the past two years are highlighted in the Implementation Plan. The key inspection areas include personnel working on key posts, quality assurance departments, quality control departments, material suppliers, material management, production control, drug distribution, adverse reaction reports, self-inspection and rectification, entrusted manufacturing and punishment for violating Drug Administration Law and other related regulations and laws.