QC Release Analysis
Quality Control (QC) Release Testing is key to ensure your product has been manufactured correctly, is of appropriate quality and will produce the desired therapeutic effect for the end user. With over 15 years as a trusted provider of Quality Control (QC) Release Testing for regulated products, we are the ideal partner for your testing, inspection, and quality control needs.
Comprehensive QC Release Testing Services
NBAB provides comprehensive QC Release Analysis services, critical for ensuring that raw materials, APIs (Active Pharmaceutical Ingredients), and finished products meet the stringent quality and safety standards required by regulatory bodies. We offer:
- Batch (Release) Testing: Comprehensive testing of each production batch to verify compliance with quality standards and specifications. Expedited turnaround times are available to suit your business requirements.
- Method Validation or Transfer Completion: QC release testing starts once the analytical method validation or transfer has been completed and the relevant documents have been approved.
- Dedicated Laboratory Contact: Each project is assigned a single point of contact within the laboratory to provide routine status updates and be available to your team for questions or issue resolution.
Regulatory compliance & reporting
NBAB operate under a validated quality management system to ensure that all data, documentation and reporting meet international standards and regulatory expectations.
- Regulatory compliance: Ensuring all testing and documentation comply with GMP / ISO and other regulatory requirements.
- Results reporting in a format to meet your needs: We can provide results via Certificate of Analysis, detailing all test parameters or in other formats to suit your specific requirements.
Consistent product quality
Why QC Release Testing is critical
Reliable QC release analysis is essential for ensuring consistent product quality, patient safety, and compliance with global regulatory standards. Comprehensive testing protocols support:
Timely market supply
Early and efficient batch release testing minimizes bottlenecks and supports uninterrupted product availability.
Risk mitigation
Systematic testing enables early detection of deviations, reducing the risk of product recalls, rework, or regulatory findings.
Audit and inspection readiness
Complete data traceability and documentation streamline preparation for regulatory audits and customer inspections.
Regulatory alignment
QC testing ensures compliance with submission requirements and lifecycle documentation for both small molecule and biologic products.
Partner with NBAB for certified QC Release Testing
NBAB is equipped to support your QC release needs, from single studies to ongoing batch testing programs. Let us help you ensure product quality and streamline your path to market.