Thesis (M.Sc.) - Cairo University - Institute of Statistical Studies and Research - Department of Statistical Quality Control and Quality Assurance

In this thesis, the answer for the question 2How to provide a statistical control for pharmaceutical products to be certified from World Health Organization (WHO)3 is represented. The WHO Guidelines through its various Technical Report Series TRSs are advised by the statistical process control and assessment, and left the way of application to the drug manufacturer, so the main aim of this thesis is to provide a model for statistical assessment and control through adoption of Oral Solid Dosage OSD product manufacturing. A pharmaceutical product is adopted and applied for statistical assessment and through this study the main skeleton of such statistical study is illustrated, looking at the Descriptive statistics, its application and interpretation from both numeric and graphical techniques. Inferential Statistics is also employed to infer the required information from the samples. Statistical Quality Control SQC Tools are employed. Before discussing or applying the analysis procedures of the data, some fundamental background knowledge of Statistical Process Control, descriptive statistics, inferential statistics and SQC is necessary to be introduced, so this is illustrated as a separate chapter. During this research, the descriptive statistics shows a good picture for the Critical Quality Attributes CQAs undergone to the study, the data include some variation and none of them show symmetric shape in description of the histograms, but this may related to the small number of batches included during study research. And by increasing this number of batches more clear picture will appear

Issued also as CD