Collaboration is essential for maintaining high-quality standards and compliance!
"Our Qualification Manager is key in supporting Project Management and Engineering"
Continuous improvement is a key focus! With us in your project you are ready to continuously review and optimize your qualification process.
This ongoing effort enhances efficiency, reduces risks, and ensures ongoing compliance with GMP.
By maintaining a robust and dynamic qualification process, the organization can achieve superior quality in its manufacturing operations.
Project Management
Ensuring Seamless Qualification and Risk Management for Superior Compliance
To achieve seamless qualification activities, our Qualification Manager assesses potential suppliers for your GMP-qualification capabilities, ensuring they meet the necessary standards for engineering activities or machine construction.
Resource management is another critical aspect, involving the planning and allocation of personnel, equipment, and materials required for successful qualification activities. Furthermore, our experts identify, assess, and mitigate risks associated with the qualification of new and existing systems. This proactive approach helps prevent costly errors, delays, and potential quality issues.
Collaboration and Coordination
The Qualification Manager will work closely with other departments, such as Project Management, Engineering, Metrology, Automation, Quality Assurance, Quality Control, Manufacturing, and Regulatory Affairs as well as coordinate Third Parties. This will ensure the work complies with GMP standards, and the definitions set in the Validation Master Plan.
Supplier Qualification
Assessment of potential suppliers for engineering activities or construction of machines on their GMP-Qualification capabilities to define possible leveraging activities.
Resource Management within the Qualification team structure
Plan and allocate resources, including personnel, equipment, and materials, necessary for the successful execution of qualification activities.
Risk Management and Mitigating Risks
The Qualification Manager is responsible for identifying, assessing, and mitigating risks associated with the qualification of new and existing systems to proactive prevent costly errors, delays, and potential quality issues.
Continuous Improvement
Process Optimization is gained by continuous review and improvement of the qualification process to enhance efficiency, reduce risks, and ensure ongoing compliance with GMP.
Expertise
Each project involves sophisticated technologies, stringent quality requirements, and the integration of new and sometimes existing systems.
Our Qualification Manager’s expertise in handling complex
projects supports the Project Management and the Engineering team and ensures
that all components work harmoniously, reducing the risk of operational
failures.
Optimized Risk-Based Qualification Strategy
Streamline resources on critical systems to cut down time and costs tied to unnecessary qualifications.
Boost compliance to ensure all high-risk systems are fully qualified, minimizing regulatory risks. Focus on key areas to enhance product quality and maintain high standards for patient safety
Execution Oversight
Oversee the establishment and execution of
qualification plans and protocols to ensure they are carried out according to GMP-requirements
and that all test results are properly documented
.
Customer Value
Ensuring compliance with Good Manufacturing Practices (GMP) is paramount.
Our Qualification Managers play a crucial role in this process by fostering collaboration and coordination across various departments, including Project Management, Engineering, Metrology, Automation, Quality Assurance, Quality Control, Manufacturing, and Regulatory Affairs.
Additionally, we coordinate with third parties to ensure all activities align with GMP standards and the Validation Master Plan.
This collaborative approach is essential for maintaining high-quality standards and regulatory compliance.
References
Building a new pharmaceutical production facility in Minden
The setup included chemical synthesis with five synthesis lines, covering reactors, crystallization, drying, and filling processes. We were ensuring everything is "kosher" and "halal" certified. Our experts were also putting together a qualification system to meet industry standards.
Expanding clients vitamin production capacity incl. fermentation in Grenzach-Wylen
We were using clients existing plant. This includes factory acceptance testing (FAT) and supplier qualification to ensure everything runs smoothly.
CMC Consulting
We ensure compliance with regulatory standards, optimizes product development, and enhances manufacturing processes, ultimately leading to high-quality, safe, and effective biopharmaceutical products.
GMP-upgrades of leverage facilities
As a biotech qualification specialist, our GMP-upgrades service ensures that your facilities remain compliant with evolving GMP regulations and adapt to changes in your product portfolio. Here’s how we achieve this!
Document Creation
We provide
document creation services that guarantee your qualification activities are
well-planned, executed, and documented to meet top compliance and quality
standards. Our Qualification Team makes sure all documents, like protocols and
reports, are accurate, complete, and align with Good Manufacturing Practices
(GMP).
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