Data Integrity In Quality Manage Ment System Of Pharmaceutical Manufacturing

Quality management system(QMS) has been widely used in pharmaceutical industry. One of the key elements is data integrity and electronic data integrity. In this thesis, author summarized inspection reports by regulatory authorities, including US FDA and EU EMA, indicating the data integrity especially electrical data integrity have become the key focus during inspections.The author presented the working experience and suggested that the data integrity can be divided into following parts: traditional data integrity problem and the electrical data integrity problem. Traditional data integrity problems include backdating, pre-recording, manipulation or falsification of records, and the electrical data integrity problems include the insufficient equipment system, insufficient personnel training, manipulation and selection on electrical raw data. The author proposed possible solution of above-mentioned problems, include updating and modifying the equipment system, training operators and establishing sufficient enforcement for data integrity.In chapter II, summarization and analysis of the FDA warning letter and EU non-compliance report since 2010 were presented in terms of the regions of the companies warned, with focusing on data integrity issues. In chapter III, the author classified different data integrity problems and the root cause. In chapter IV, the author proposed the solutions to minimize data integrity issues.The purpose of this thesis is to provide the enlightenment and assistance to the pharmaceutical companies specifically in raising standard of data management and integrity. Through the excises, pharmaceutical manufacturing organizations will prepare themselves for meeting challenges either from regulations or from inspection by regulatory agents.