It must be possible to carry out audits in a foreseeable period of time. To this end, the object of the audit must be narrowed down in advance. It can be carried out on the basis of the system, product, procedure or area.
Systems are interrelated or interactive elements, which, as a whole, form a unit with a joint purpose. The functionality of systems is reviewed by assessing the individual elements and their interaction with each other. System audits include the audit of the areas and procedures that are crucial for the functionality of the system. Examples of systems are given in figure 1.
Figure 1 Examples of systems
With a product-based audit, the development of a product or a group of comparable products is traced from the raw materials to the secondary packaging. One or more batches of the product are checked on the basis of the application file for marketing authorization. Here, the documents specified in figure 2 form the basis for the review. Manufacturing areas and procedures are included in the audit to the extent that they are relevant for the product. This audit type is usually used on contract manufacturers by contract givers.
Figure 2 Focuses of product-based audits
Procedures are activities that are carried out in a specific way. Their execution method is usually described in procedural instructions. On the one hand, procedure-based audits check if the procedure defined in the instructions leads to the intended objective, i.e., if the regulatory content and scope are described in a suitable and adequate manner (cf. figure 3).
Figure 3 Examples of procedure-based audit topics
In light of the fact that the procedural instructions have already been subject to a technical review during their approval procedure, this control seems superfluous. However, in practice it has proven necessary, because process sequences are influenced by changes in the general operating conditions. Many small changes that are not recorded by the change control procedures can make it necessary to bring the procedure, once established, in line with the changed conditions. On the other hand, procedure-based audits should also show, if the requirements defined in the procedural instructions are fulfilled in practice by the equipment and staff (compliance audit). For example, the maintenance and calibration status of the equipment can mean that it is not possible to achieve or comply with the established parameters and thus the requirements are not met. If staff is given insufficient training on the procedural instructions, implementation problems can occur due to a lack of staff qualification. Internal organization deficits and the work motivation of the staff can also lead to a procedure not being executed in the prescribed manner. The practical experience of the staff is a valuable source of information for the continuous improvement of the procedure. The audit should therefore be executed in close collaboration with the on-site staff concerned.
The audit of defined areas, such as the warehouse, the packaging department, the weighing center or the changing rooms and washrooms, offers the possibility of formulating the audit plan so that the entire company is inspected within a defined period of time. In addition to the procedure-specific aspects, it is also possible to check the conditions for the area. Figure 4 shows a selection of topics that can be taken into account in area-based audits.
Figure 4 Topics for area-based audits
The objective of the audit determines the audit procedure and the focus of the audit. Topics for system-based, product-based, procedure-based and area-based audits are presented.
Dr. Michael Hiob
Ministry for Health of Land Schleswig-Holstein, Germany
Max S. Lazar
FDA Regulatory Compliance Consulting, USA