That was yesterday: process validation as “documented proof that a certain process reproducibly leads to a result that corresponds to the given specifications and quality requirements”. Performed at least 3 times and adequately documented. Today that alone is no longer sufficient for GMP compliance. Buzzwords like “lifecycle approach” and “continued process verification” are going around in the context of risk management. These are increasingly required by authorities and expected in the course of inspections. cGMP.
Process validation from today’s perspective is purposeful, with beneficial results not only for the authorities but also for the processes and production itself! Yet always pragmatic and feasible. That is what gempex ensures.
In-depth Process Knowledge is Essential
While process control had to be demonstrated in the past, several times in a row, today the focus is more on a deeper understanding of the physical, chemical and biotechnology processes. What attributes are critical to quality, what are the correlating critical process parameters? The gempex experts provide support for analysing processes in view of these points. They help identify these parameters with suitable risk analysis methods.
Variations – Please Only in Justified Cases
Intra-batch and inter-batch consistency has to be demonstrated. Data must be collected within the scope of increased in-process inspections. Sample collection, analysis, evaluation. And of course statistics. Fluctuations must be explained and remain within an acceptable range. To keep all of this from getting out of hand, the gempex experts intervene with pragmatic process models. They develop suitable sample collection strategies, propose the right statistics tools and help with evaluation.
…and How Long Should All That Take?
We understand, we know how difficult and virtually impossible it is to master such complex life science processes to perfection. The processes themselves have become increasingly complex, learning a lifetime task. Data need to be collected continuously throughout the lifecycle and evaluated regularly. Results and conclusions have to contribute to improving process control. Here gempex has extensive experience to keep the effort manageable. And establishes the right mechanisms to efficiently achieve GMP compliance over the long term.
What Processes Need to Be Considered Exactly?
Process validation – like the gempex know-how – is not limited to manufacturing processes alone. It also encompasses the validation of cleaning, disinfection and sterilisation processes and the validation of analytical test methods. Not only was experience collected in the course of numerous projects, a large number of tools to make implementation easier was developed as well. This provides a head start for new projects.
- introduction to modern process validation methods
- concepts and models that keep the effort manageable
- experts with sufficient process understanding who help analyse critical quality attributes and process parameters
- support with the implementation of a lifecyle model
- consultancy and know-how for the validation of manufacturing, cleaning, disinfection and sterilisation processes and analytical test methods – from one source