CAPA, PQR, Change Management



Introducing GMP systems requires time, money, human resources and: a lot of expertise. Once established, the main effort is over. Now it's time to keep the system alive, to maintain it. Like a well-designed garden, to prevent overgrowth and weeds, which would otherwise require enormous physical effort, you would have to start all over again. For this purpose, there are tools firmly anchored in the GMP rules, maintenance tools. Medcycle provides the know-how and experienced experts for continuous system maintenance on a permanent basis.

CAPA – Corrective Actions, Preventive Actions

There is no such thing as error-free, and even the best, firmly established GMP system is not without deviations. The processes are too complex, include a human factor and therefore are prone to errors. But one can learn from them, provided one finds the root cause. Accordingly, GMP deviations must be recorded and described, causes traced and the process evaluated. And then corrective action must be taken. Measures are to be defined that exclude a repetition with the highest probability. A valuable process for the overall GMP system.

Change and risk management

It is no different with changes, mostly driven by previous errors or by targeted optimizations. A good system is required that captures such planned changes, evaluates them and establishes any necessary safeguards and controls. In order to counteract risks in a controlled manner and to develop potential at an early stage.

And whether deviation or change - the processes are always accompanied by a risk assessment. In the form of a short statement for quick evaluation or as a detailed FMEA. You have to estimate and get clarity about the impact on product quality and thus consumers that the deviations or changes could have. In practice a continuous process. Recognize risks, record them in writing, summarize them, check them regularly and communicate them to the right people.

PQR – Product Quality Review

With all dynamics, with all occurrences, planned or unplanned, the overview must be maintained. Critical trends must be identified in good time, and corrective action must still be possible. Therefore, the GMP rules prescribe annual "Product Quality Reviews" to be carried out. A summary and statistical evaluation of all quality indicators, from customer complaints and recalls to listing changes, deviations, re-qualifications and re-validations. Trend analysis - looking into the future - is required. Is the product quality still guaranteed at all times?

... if the backlog says hello: system maintenance via onsite execution

It is clear that all this maintenance work is not without effort and that it is not insignificantly dependent on the complexity of the tools. If the company bases its KPIs, the Key Performance Indicators, on the backlog, the task can cause enormous trouble. In such cases, Medcycle's Onsite Execution offering can be considered. Motivated, systems-trained and continuously trained experts assist in handling discrepancies, changes, risk analysis and much more. Critical system testing is also performed when systems are clearly too complex and optimization is needed. Reliable, continuous maintenance and review of the systems by experts.