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Quality needs to be designed into a product - it cannot be tested into it.

Quality by Design (QbD)

Is QbD unknown to you?

As a requirement of the new guidelines, process know how and quality awareness should be combined. The following principle is valid: quality cannot be tested into a product. The focus has therefore shifted from quality control to process understanding. The combination of ICH Q8 (pharmaceutical development), ICH Q9 (quality risk assessment) and the ICH Q10 (pharmaceutical quality system) is the key to success.

Do you know your quality relevant factors of your process? Which factors can be covered by QbD? Which factors can be influenced? Do you have answers to all those questions? We support you with our 20 years of experience.

We assist you during the development phase of your product, precisely in

  • Definition of your quality target product profile (QTPP)
  • Definition of your production process
  • Definition of your critical quality attributes (CQA)
  • Definition of your first critical material attribute (CMA) and the relevant critical process parameters (CPP)

In doing so, we generate your first risk assessment as well as the master batch records (MBR) with the corresponding documents.

During process development we support you with:

  • Review and adaption of the CQA
  • Functional dependance of the CMA, CPP and CQA as well as the corresponding measures
  • IPC Strategy (InProcess Control)
  • Process risk analysis (FMEA Failure Mode and Effect Analysis)