8 Quality Management and GMP

We monitor quality processes for you, either at your premises or those of your suppliers. Higher quality leads to more stable processes and better products. This, in turn, increases your added value.
Good Manufacturing Practice (GMP) forms the basis for this. GMP alone is not sufficient for efficient processes. Quality by Design (QbD) and Design of Experiments (DoE) provide high added value and accelerate workflows.

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The overall quality is crucially dependent on the weakest link in the quality chain. We analyse your quality processes and those of your suppliers. We improve quality without creating a new flood of documents. This is how you achieve higher added value.

Whether it's Good Manufacturing Practice (GMP) or ISO 9001, we manage your quality processes as an outsourced service or improve and optimise your own procedures.

We enhance the quality of processes and products. This increases your value creation.
Contact one of our experts for a conversation and consultation.

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Good Manufacturing Practice GMP

Quality management is your advantage!

Quality
Management is your advantage!

GMP and ISO 9001

Our experts are at home in both quality systems. This is how we specifically expand your quality systems and align the different systems with each other.

Quality processes

We take on and manage complete quality processes for you. Supplier management, complaint management, validations, and transfers are processes that we can manage well for you.

Business processes

We analyse your business processes to discover and make available quality potential for you. This way, you increase quality and value creation together.

Unlock potential

Increase your chances of success. Contact one of our experts for a detailed consultation.

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Speak to one of our consultants about your challenge and your project.

FDA Notice on Quality System

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that
is based on International Organization for Standardization (ISO) quality concepts, and includes
applicable Good Manufacturing Practice (GMP) regulations, and complements
ICH “Q8
Pharmaceutical Development” and ICH “Q9 Quality Risk Management.”

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FDA Notice on the Quality System

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that
is based on International Organization for Standardization (ISO) quality concepts, and includes
applicable Good Manufacturing Practice (GMP) regulations, and complements
ICH “Q8
Pharmaceutical Development” and ICH “Q9 Quality Risk Management.”

ICH Q10 describes a comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations, and complements
ICH “Q8 Pharmaceutical Development” and ICH “Q9 Quality Risk Management.”

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