Qualification / Validation

Qualification Concepts

The prerequisite for efficient qualification is a comprehensible concept. It is the only way to reconcile requirements from the authorities, costs and resources.

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Risk Analyses

GMP risk analyses are key for successful inspections by the authorities – at the latest since the FDA established the “Risk-Based Approach”. By means of systematic analysis, the risks in processes and production facilities can be determined, assessed and reduced by defining appropriate actions.

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Qualification Phases

Using the concept already drafted, qualification takes place in a structured way in defined phases. In the interest of lean and thus cost-efficient qualification all activities are executed in close coordination with the development process, that is, the planning and execution.

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Cleaning Validation

One basic GMP requirement is that the cleaning processes of equipment and facilities relevant to quality have to be validated. Both national and international authorities require this. Whereas in the past, the operator himself always had to set his hand to it, competent service providers are now available.

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