Streamlined Compliance ensuring Seamless Qualification for Superior Manufacturing !
"By following a well-organized approach, your qualification teams ensures that everything transitions seamlessly into manufacturing "
Having a dedicated Qualification Manager means that all qualification activities are well-documented and ready for audits.
This preparedness is crucial for passing regulatory inspections and maintaining continuous compliance. Effective qualification management not only ensures the smooth operation of manufacturing processes but also safeguards the company from potential legal and financial headaches.
Document Creation
Ensuring Compliance and Smooth Transitions
Our Qualification Specialists ensure all qualification documents, including protocols and reports, are accurate and GMP-compliant. They prepare comprehensive final reports detailing their activities and any resolved issues. The Qualification Manager oversees equipment calibration, ensuring a smooth startup and seamless transition to manufacturing. This organized approach is crucial for passing audits and avoiding costly production delays.
Validation Master Plan (VMP)
We're all about creating and keeping up with the VMP, which lays out how we handle all our qualification activities like Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This plan clearly defines everyone's roles and responsibilities.
Qualification Plans and Protocols
Our team will draft, review, and approve the qualification protocols for IQ, OQ, and PQ. These documents will specify the procedures, acceptance criteria, and the required paperwork for qualification activities.
Support During FAT/SAT
The Qualification Team will be on-site during Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to ensure we’re following all current Good Manufacturing Practices (cGMP) while leveraging our qualification activities.
Change Control Management
When changes happen in qualified systems, equipment, or processes, we’ll document each one. This ensures that every change is assessed and qualified before we go live with it.
Deviation Management
If we run into any deviations or issues during our qualification activities, we’ll identify, document, and manage those on the spot.
Documentation and Reporting
The Qualification Team will ensure that all qualification documentation, including protocols, reports, and data from the vendors and machinery manufacturers, are accurate, complete, and compliant with GMP requirements.
Our experts will compile and review final
qualification reports, ensuring the summary of the qualification activities and
results, including any deviations and their resolutions.
Seamless startup for calibration and maintenance
The Qualification Manager will review the Equipment and Instruments list to control and plan the calibration activities for qualification and start up. Seamless startup will be guaranteed up to manufacturing by continuously using the same equipment list and tables.
Audit
Readiness
A dedicated Qualification Manager ensures that
all qualification activities are well-documented and audit-ready. This is
crucial for passing regulatory inspections, which are necessary for obtaining
the company’s operational licenses and avoiding potential legal or financial
penalties due to manufacturing delays.
Customer Value
The Qualification Team plays a critical role in this process by ensuring that all qualification documents, such as protocols and reports, are accurate, complete, and compliant with GMP.
This meticulous documentation is vital for passing regulatory inspections and avoiding any legal or financial issues that could arise from manufacturing delays.
Our Qualification Experts are responsible for creating final reports that detail relevant activities, results, and any issues encountered, along with how these issues were resolved.
This comprehensive documentation ensures transparency and accountability. By following a well-organized approach, the team ensures that everything transitions seamlessly into manufacturing.
References
New Facility for Peptide Production and Lipid Purification, Fechenheim
This includes three synthesis lines equipped with SPSS, reactors, HPLC, freeze-drying units, and cleanrooms, allowing for flexible configuration of different sections.
Qualification of Cleanrooms for Producing Sterile Glass Vials, St. Gallen
Cleanrooms classified A-C, including qualification for the expansion of the compressed air system.
New Laboratory for the Production and Testing of Bio-Indicators, Allschwil
This will feature cleanrooms B-D, isolators, along with lab and fermentation equipment.
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.
Project Management
We use a risk-based qualification strategy that targets critical systems, saving time and costs by skipping unnecessary qualifications. This not only enhances compliance with regulations for high-risk systems but also helps maintain product quality and patient safety. .
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!
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