Construction And Practice Of QC Laboratory Management Standardization For Psychotropic Drugs-Caffeine

All the pharmaceutical companies are facing a challenge to ensure the drug quality and manufacture to meet the GMP (Good Manufacture Practices) with the growing public and authority stringent supervision and the improving of the regulations. With the great expansion export to oversea market of the domestic API and more and more cooperation to the worldwide pharmaceutical companies, the quality supervision on the API supplier chain from the oversea customer and authority agencies become more and more stringent. QC (Quality Control) as one of the sixth GMP system, which should be inspected no matter customers, nor FDA (Food and Drug Administration) and EDQM (European Directorate for Quality Medicines).Although different auditors may focus on different points, they must all focus on the ICHQ7A(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) to covering the GMP six systems, therefore, the QC laboratory management should be based on ICH regulatory to study and establish relevant QC management standard and put into practice to satisfy the international requirements.As psychotropic API, the management of caffeine is different from the ordinary APIs. This thesis takes caffeine as an example to study and establish a series of QC lab management standards on psychotropic API on basis of psychotropic drugs regulations and ICH regulations.Also, study and analyze the finding deficiencies from FDA,EDQM and major customers to improve all the relevant management standards to satisfy the QC laboratory management requirements and further more to guarantee the quality control.First of all, make a brief description of the current situation of domestic QC lab management, for there are no detailed requirements on the QC management in ICH and GMP, which lead many laboratories management deviate from the requirements (nonconforming aspects of QC lab management); secondly, take caffeine as an example to divide the QC lab management into5steps as per analysis procedure including personnel management, sampling management, retention sample management,analysis management and CoAs issue management and discuss the detailed risk analysis of each step to establish and implement a set of details management and process risk control management procedures as per ICH and GMP requirements; thirdly, find the deficiencies on basis of the findings observed during the FDA,EDQM and other customers and initiate corrective actions and protocol to improve the QC lab management system; finally, summarize the whole thesis.As one of the six systems and a part which is impossible to be skipped from inspection during audit, QC laboratory management is one of the most important factors as the last step of quality control. This thesis focus on establishing a series of QC lab management procedures for psychotropic API by referring the FDA and EDQM inspection of caffeine, ICH and regulations on psychotropic drugs to share with the domestic and oversea psychotropic API manufacturer, to avoid detours in the QC lab for psychotropic API and speed up the QC lab management level to seize the forerunner position in the international marketing competition.