The Study On The Civil Liability For The Third-Party Auditing Of Pharmaceutical Excipient’s Quality

The State Food and Drug Administration (SFDA) reissued "the Pharmaceutical Raw Materials and Excipient for the Record Management Regulation (Draft)" on November30th,2011, declaring pharmaceutical excipients who have national standard should implement filing system and the pharmaceutical companies should assume liability for auditing theirs excipients.This thesis suggests introducing the third-party auditing. Because of its advantages, it can improve the auditing ability of pharmaceutical manufacturers as well as the production efficiency of excipient companies.This thesis mainly contains five parts. The first part defines the third-party auditing. The second part’s main content is.to analyses the feasibility of the third-party auditing through the excipient management system changes, both of pharmaceutical manufacturers and excipient companies’demand under the new management system, and the advantages of the third-party auditing. The third part refers to the details of the auditing. The forth part confirms that the contrast, between pharmaceutical companies or excipient firms and the third-party auditing, is an entrusted one according to Contact Law. The last part is about the liability of relative parties on the basis of general rules of Civil Law、Contract Law and Tort Liability Law. In this part, the author pays attention to talking over the civil liability for breaches of contract and tort liability among parties.This thesis aims at defining the property of the third-party auditing institution under the current situation of pharmaceutical excipient industry, and confirming legal questions among the third-party auditing institution, excipient companies and drug manufacturers, to make a better understanding of the third-party auditing institution for these relative parties and promote the implement and development of it.