Requirement for the Manufacture of Drugs concerning Public Safety
The study will focus on pharmaceutical companies’ standard operation procedures. More in depth, the study will determine if cleaning validation and verification is a successful way to keep the quality of manufactured drugs at a high standard. The importance of the validation of a sterilization process will be examined. The study will list reasons for validation of sterilization through a set of regulatory expectations put in place by the FDA.
The regulatory expectations of the FDA will support the methods and analysis used to conduct this study. The study will also examine the success and failure of cleaning