To define the frequency and scope of audits, both internal and external, taking into account factors such as:  Existing legal requirements;  Overall compliance status and history of the company or facility;  Robustness of a company’s quality risk management activities;  Complexity of the site;  Complexity of the manufacturing process;  Complexity of the product and its therapeutic significance;  Number and significance of quality defects (e.g., recall);  Results of previous audits/inspections;  Major changes of building, equipment, processes, key personnel;  Experience with manufacturing of a product (e.g., frequency, volume, number of batches);