8 Quality Management and GMP

We manage quality processes for you at your site or at your suppliers. Higher quality creates more stable processes and better products, thereby increasing your value creation.
Good Manufacturing Practice (GMP) is the basis for this. GMP is not enough for efficient processes. Quality by Design (QbD) and Design of Experiments (DoE) bring high value creation and acceleration of processes.

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Overall quality depends crucially on the weakest link in the quality chain. We analyze your quality processes and those of your suppliers. We improve quality without creating a flood of new documents. This is how you achieve higher value creation.

Whether Good Manufacturing Practice (GMP) or ISO 9001, we manage your quality processes as an outsourced service or improve and optimize your own operations.

We increase the quality of processes and products. This allows you to increase your added value.
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 strategically expand your quality system and coordinate the various systems with one another.

Quality processes

We take over complete quality processes and manage them for you. Supplier management, complaint management, validations, and transfers are processes that we can successfully handle for you.

Business processes

We analyze your business processes to discover quality potential and make it available to you. This is how you jointly increase quality and value creation.

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

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FDA Quality System Notice

ICH Q10 describes one 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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FDA notice regarding 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, includes
applicable good manufacturing practice (GMP) regulations, and complements
ICH Q8
Pharmaceutical Development” and ICH “Q9 Quality Risk Management.”

ICH Q10 describes one 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.“

See more
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