chapter  22
9 Pages

Quality Assurance

ByHelena M. Van den Dungen, Earl W. Hulihan, and Richard A. Guarino

INTRODUCTION To enable appropriate decision making on the safety, and efficacy and value of new and marketed medicinal products, it is clearly of the utmost importance that the available information and data on these products should be of high quality. Throughout the life cycle of a product, it is essential to ensure that the clinical trials that form the basis for product approval by the Regulatory Authorities are conducted with the highest degree of safety for the subjects participating in the clinical trials. In addition, the results reported must reflect the highest quality of data. Likewise, the same level of quality and safety should be applied post marketing through pharmacovigilance activities. An important instrument to ensure the quality, safety, and completeness of the essential information is the implementation of quality control (QC) and quality assurance (QA) processes throughout the drug’s life cycle.