A QA system must ensure that there is a self-inspection process available and implemented, leading to a programme of critical self-evaluation and continuous improvement. A very important part of the management of the manufacturing operation is the means of auditing the operation for its compliance with all the GMP requirements. The auditing is done at several levels within the company. There should be an internal audit function within departments (self-inspection). This is backed up by quality audit, an independent internal organization, charged with looking at all departments and assessing the application of the quality system within a company.

The ultimate auditing organization is the external auditing organization. This is normally the drug regulatory authority inspection or audit. See section 9.

Duties and responsibilities for the individual tasks need to be clearly defined and assigned to departments and individuals. This should be done in writing. Again, this is all part of the SOP process. Every department involved in quality assurance should have SOPs that describe its activities and who is responsible for carrying out those activities.

Reporting, investigation and recording of deviations

System for change control/approval

Regular evaluation of product quality to verify consistency and continued improvement