Self-Inspection – How to Identify Your GMP Weaknesses Before the Authority Does

Sometimes one is not only surprised about deficits in one's own company, but also amazed at which processes and facilities function smoothly and more than exemplary. Self-inspections offer the opportunity to identify weaknesses, work on them and develop solutions for the weak points from identified strengths.

What are the goals of self-inspection?

Self-inspections primarily pursue the goal of improving the quality of internal processes and systems and are thus an important component of the company's own quality assurance system.

In addition to pure compliance with specifications such as procedural instructions, their suitability in relation to existing, changed or new requirements must also be reviewed. Furthermore, processes or documents should be reviewed under the aspect of improvement in order to determine to what extent they contribute to error prevention.

Also evaluate the effectiveness of CAPA measures, for example from deviations or change processes. This allows conclusions to be drawn about the quality of the definition of CAPA and potential risks can be identified, for example after reconstructions.

Through surveys on quality requirements or processes, you can assess the professional understanding of staff and at the same time evaluate how effective their training systems are.

In addition, self-inspection offers a good opportunity to talk to each other and to communicate an understanding of quality requirements.

Last but not least, and this point should not be underestimated, self-inspection is also an important exercise for the inspection or audit situation.

Which areas need to be self-inspected and how can I go about it?

All areas that have a potential influence on product quality or related processes must be subject to self-inspection:

• Staff
• Premises
• Maintenance of buildings and facilities
• Calibration of displays and measuring systems
• Purchase and storage of raw materials, packaging materials, intermediate and finished products
• Manufacturing processes
• In-process controls
• Validation and qualification programmes
• Quality control
• Documentation
• Cleaning, disinfection and hygiene
• Recall procedure
• Complaint management
• Data management and data integrity
• Results of previous self-inspections and corrective actions
• Carrying out self-inspections
• Change control system
• CAPA system

A long list that you can certainly continue. How you select the areas of inspection is ultimately up to you. Above all, the selection must fit your quality management system. It can be department-oriented, process-oriented or system-oriented. Each of these variants has advantages and disadvantages and you have to weigh up which one works best in your particular case.

The departmental approach focuses on internal departmental processes and their documentation. They are easy to handle and plan because only one or a few departments are involved. However, this approach lacks a holistic perspective, especially when cross-departmental processes come into play.

These are taken into account in process-oriented self-inspections, which are, however, more time- and personnel-intensive. Examples include the processes following an equipment defect or the processes from sampling to the resulting certificate of analysis. Occasion-based self-inspections after recall actions, repeatedly occurring complaints, deviations or OOS results usually start with a product-specific inspection in which the associated processes are evaluated.

Finally, system-oriented self-inspection, in which individual quality systems are checked, is particularly suitable for preparing an inspection by the FDA, as the inspectors' perspective is adopted here.

As with the process-oriented inspections, the effort is relatively high compared to the department-oriented inspections.

Tips for the daily GMP routine

1. The primary purpose of self-inspection is improvement. Therefore, deal openly with possible problems, weak points and uncertainties.
2. Self-inspections should be conducted in a positive, open atmosphere. Therefore, announce routine self-inspections well in advance. Required documents and information can thus be compiled in advance and waiting times during the self-inspection can be reduced.
3. And finally: practice, practice, practice. Auditing is a constant learning process - no perfect auditor has ever fallen from the sky.

The article is a translated excerpt from episode 19 of the German webcast GMP & TEA "Self-Inspection".