CAPA, PQR and Change and Risk Management (GMP System Maintenance)

Implementing GMP systems takes time, money, personnel and lots of expertise. Once established, most of the effort is behind you. Now the system needs to be maintained and kept alive. Like a well-tended garden, preventing uncontrolled growth and weeds that would otherwise take tremendous effort if one had to start all over again. Tools for the maintenance of GMP systems are firmly anchored in the GMP rules. The required know-how and experienced experts for ongoing system maintenance can be provided by gempex over the long term.

CAPA – Corrective Actions, Preventive Actions

There is no such thing as freedom from defects. Even the best, firmly established GMP system will have deviations. The processes are too complex, run by people and therefore not free of errors. But one can learn from them, provided the root cause is found. That is why GMP deviations need to be recorded, described, the causes investigated and the process evaluated. Then corrections need to be made. Measures have to be established and recurrence excluded with the greatest likelihood. A valuable process for the overall GMP system.

Change- and Risk Management

Changes also need to be managed, mostly driven by previous errors or the quest for optimisation. A good system is required to record and evaluate such planned changes, and to establish all necessary monitoring and control measures. To address risks in a controlled manner and realise potential early on.

For both deviations and changes, the processes are always accompanied by a risk assessment. This can take the form of a brief statement for a quick assessment, or a detailed FMEA. The possible effects of deviations or changes on product quality and therefore the consumer need to be assessed and clarified. This is a continuous process in practice. Risks are identified, recorded in writing, summarised, regularly reviewed and communicated to the relevant recipients. 

PQR – Product Quality Review

With all of these dynamics, with every planned or unplanned event, maintaining an overview is essential. Critical trends need to be identified in a timely manner, while corrective intervention is still possible. That is why the GMP rules call for conducting annual product quality reviews. A summary and statistical analysis of all quality indicators, from customer complaints to recalls to listing changes, deviations, requalifications and revalidations. Trend analysis – looking at the future – is required. Is product quality still assured at all times? 

…when a Backlog Develops: System Maintenance through Onsite Execution

Caring for the system naturally takes effort, the extent of which largely depends on the complexity of the tools. When the company bases its KPIs Key Performance Indicators on the backlog, the task can cause tremendous distress. That is when Onsite Execution offered by gempex should be considered. Motivated experts with knowledge of the system and permanently current training provide support for processing deviations, changes, risk analyses and much more. Also critical system reviews are conducted when the systems are visibly too elaborate and require optimisation. Reliable, continuous system maintenance and verification by experts.


  • support from well trained and prepared experts
  • assistance at short notice and in peak phases
  • elimination of CAPA and change backlogs
  • relief in the preparation of PQRs
  • preparation or revision and reconciliation of risk analyses at all levels
  • no more sleepless nights