ABSTRACT
So far I have put forward a whole series of possible problems and general solutions. It is QA’s job, however, to implement a solution that encompasses all aspects of an organization’s business, whether it adheres to the U.S. Food and Drug Administration’s (FDA’s) Good Practices standard (GxP) or some other standard. In order to give you a sense of the types of items we look for in our organization and to put you on the right track regarding inspections and audits, I will provide you with some checklists that you can use to set up, or perhaps even improve, your existing quality system. Such lists are not exhaustive and only cover the main points that QA thinks are the critical areas (Table 5.1). As with any checklist, the inspector or auditor must feel free to curtail or expand any inspection or audit.
