Risk-based qualification in the GMP area is both an opportunity and a challenge

With a risk-based approach effort and costs of GMP-compliant qualification can be reduced without loss of quality.

The risk-based qualification process can be described easily: there is the risk-based approach of validation and the risk-based implementation of qualification. The risk-based validation approach is the fundament of modern quality systems across all industries in order to identify GMP-critical process steps and plants. In pharmaceutical manufacturing, the risk-based approach must be implemented as early as possible. In order to identify the subsequent scope of validation and qualification and reduce it to the GMP essential components, quality risk management specifications (ICH Q9) and defined risk analysis methods (e.g. FMEA) need to beĀ  implemented. This avoids additional qualification effort, saves time, resources and costs.

For GMP-compliant production, qualification according to pharmaceutical regulations is legally binding and follows an internationally accepted and harmonized standard.

Qualification test scope (DQ, IQ, OQ, PQ) arises from the User Requirement Specification (URS), functional design specification (FDS) and is a result of the technical risk analysis of the equipment. To make risk-based qualification even more efficient, verified facts from the Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) can be transferred to qualification and must not be checked again.

Valicare GmbH, a subsidiary of Bosch Packaging Technology, supports pharma customers from global markets with the implementation of risk management, the execution and documentation of risk analyses and the qualification of facilities and equipment starting with the preparation of the URS up to the execution of the qualification.

We offer specific and high efficient service worldwide always up to date on the relevant guidelines and regulations.

Call us for support (+49 69 7909 350) or attend our training on GMP-compliant risk-based qualification October 23, 2018. Register for free now:

Dr. Ellen Sons-Brinkmann
+49 69 7909 350

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