PROCESS VALIDATION

Validated Processes in Pharma & Medical

Smart quality designed into the processes using the right tools

Too often customers get their deliveries not on time, some batches are written off, and so much time and effort is wasted due to deviations. What a business case! On top of it: only with sanely validated processes products are safe.

So, does that mean you should put more resources into validation? Explain on more paper that it’s good as it is developed? Conduct longer studies to average out results?

Of course, the answer to all the questions above is “no”. Anticipating more challenges to your validation documentation according to GMP by FDA, EMA or other authorities is realistic and actually not a bad thing.

Can a seamless cross-functional effort of Quality Management, Quality Assurance, Process Development, MS&T, Sourcing, and Supplier Qualification be even better though faster? Our answer is a clear “yes”.

We support facilitated efforts with high involvement of people and improve statistical approaches. Find and define optimum parameter settings and control the processes with appropriate measurement systems and sample sizes. We can help to implement risk assessments that are reliable for parametric validation in production.

Last but not least, methods are valid only, if everyone sticks to the rule. Here we build on proven Lean tools to put this into practice.

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Preparation:

Review the situation and understand the objectives

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Validation process improvement:

Uncover process gaps and set-up for improved collaboration

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Statistical approaches:

Understand the potential for improvements & implement sound practices

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Trainings:

Statistical tools, simulations, experimental approaches, value stream implementation tools

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Performance Management:

Set up sustainable systems, drive the improvement