GxP-Blog

Periodic self-inspections of the pharmaceutical quality system are prescribed for pharmaceutical manufacturers in the EU (Chapter 9 of the EU GMP Guide). These self-inspections of all areas of the quality system are generally carried out by quality assurance employees. The exception to this is the inspection of the quality assurance itself. In this case, self-inspection in the truest sense of the word is excluded from the regulatory side, as an independent audit must be carried out. Designated employees from other departments with adequate knowledge and experience are eligible as auditors for quality assurance self-inspection, as are external persons with appropriate qualifications. It is preferable that self-inspection be carried out by an external person to ensure sufficient objectivity and neutrality. Because in general, it is important to avoid self-inspections that are not truly effective and unbiased.

Quality assurance plays a central role in the self-monitoring of the quality system of pharmaceutical manufacturers. It is a check to ensure that all GMP requirements have been put in place and implemented internally. As part of the self-inspection of the pharmaceutical quality system, it verifies this for all other areas of the system, including personnel, facilities, equipment, documentation, production, quality control, material and goods storage, distribution of medicinal products or active pharmaceutical ingredients and handling of complaints and recalls.

The strategy of the supervisory authorities in their inspections is increasingly shifting towards auditing self-monitoring processes in the quality system. This means that the focus of official inspections lies increasingly with checking the adequacy and function of quality assurance. The implementation of quality assurance self-inspection by external GxP experts should therefore be used as preparation for regulatory inspections. One advantage of this is that new perspectives and experiences from other quality systems and projects are incorporated into the audit.

One common question centers on the scope and duration of the inspection. As quality assurance is the essential control body in the pharmaceutical quality system, an appropriate inspection period should be chosen, at least half a day to one day per year. Various factors such as the number and scope of quality assurance tasks in the company, the size of the company, the size of the quality assurance unit and changes in the organization and processes, among others, must be taken into account. Modifications such as a change in the document system or innovations in regulatory and legal requirements can become an important test point.

Self-inspection of quality assurance should not be limited to reviewing the company's internally defined specifications and processes for implementing GMP requirements. These only represent the current status of the quality system. A review of the process for integrating regulatory and legal innovations into the pharmaceutical quality system is also important. It is expected that this process will be set up in such a way that all relevant regulatory and legal innovations are identified and listed at an early stage and their implementation is tracked in an appropriate manner.

Implementation and results of self-inspection of the other areas of the quality system by quality assurance should also be scrutinized. This also means that the topic of self-inspection as a whole must be put to the test.

This starts with the use of checklists and ends in the way inspection results and derived actions are documented and tracked.

Checklists are a good way to avoid omitting important points when there are usually a large number of items to be checked. In addition, checklists can help auditors to determine relevant inspection and focal points in advance and to track them using the checklists. However, one thing should be avoided: Checklists with selected points, which the auditor already knows have been achieved prior to the audit.

It is not uncommon to keep separate lists for observations from external and internal inspections. The reason for this is that you can and want to talk more openly about deviations and quality problems internally than with the supervisory authorities. It also avoids disclosing the “internal observations” to the authorities. However, this segregated treatment of nonconformities usually results in actions resulting from internal inspections being tracked with less stringency and urgency than actions resulting from customer or regulatory inspections. The criticality of the observations is therefore no longer the decisive factor with regard to the stringency or urgency for implementing the measures. This should also be avoided in the case of separate treatment.

In addition to the items listed in checklists, appropriate consideration should also be given to the function and performance of the quality assurance department. These include issues such as overdue deviations, outstanding significant quality assurance issues and documentation deficiencies.

The department manager of the area under audit should be responsible for processing the observations/deficiencies, i.e. in the case of quality assurance self-inspection, the head of quality assurance. The response must take into account issues such as corrective actions, impact analysis, root cause analysis, preventive actions, effectiveness review and timing objectives.

The auditor is responsible for approving or requesting rectification. It can be helpful to jointly identify and determine suitable measures already within the self-inspection process. 

And one important test point should never be overlooked: Follow-on inspections should always take into account the processing of defects from the previous inspection.

Monitoring and observing compliance with cGMP compliance are central functions of quality assurance in the pharmaceutical quality system. The self-inspections of the quality assurance department should not be carried out by the company’s own quality assurance department itself, but rather by independent auditors. Chemgineering will be happy to support you with an expert from our team of experienced, competent auditors. Our task is to identify potential defects in quality assurance and to work with you to identify solutions for eliminating these defects. In this way, the following goals are achieved simultaneously:

• The regulatory requirement for self-inspection of quality assurance is met
• the tasks and functions of quality assurance are verified and, if necessary, recommendations are made for achieving cGMP compliance and/or optimization in the context of quality assurance
• in the run-up to official inspections, companies can successfully prepare for these inspections
• implementation of measures resulting from the inspection is tracked independently