AGC Biologics
Quality Assurance Services
FromAGC Biologics
At AGC Biologics, the enhancement and continuous improvement of Quality is the responsibility of every individual. As part of our intent focus of our customers’ compliance needs, we track new regulations and monitor and implement new regulatory trends. Our Quality Assurance teams are dedicated to ensuring compliance with all necessary regulations and requirements.
Most popular related searches
reference material
area monitoring
compressed air
environmental monitoring
analytical method validation
sample processing
environmental monitoring system
method validation
steam cleaning
compliance monitoring
Our Quality Assurance capabilities and assets include:
- Integrated quality system incorporating US, EU and ICH cGMP requirements
- Comprehensive Quality Agreements
- Regulatory compliance and validation expertise
- Quality support of process validation
- Dozens of successful client audits and regulatory inspections
- EU GMP Certification
- Qualified Person (QP) release of batches
AGC Biologics conducts a broad range of analytical testing that is critical to the quality of your product. The Quality Control teams are responsible for testing all aspects of product quality and facility control.
- Testing of cell banks, raw materials, reference materials and other materials for cGMP production
- In-process, intermediate and final product release testing (bulk drug substance, drug product)
- Analytical method implementation and validation
- Environmental monitoring of classified cGMP production areas
- Monitoring of critical product contact utilities (WFI, HPW, clean steam and compressed air) for cGMP production
- Handling of raw material and product reference samples
- Analyses of samples from process and cleaning validation studies
- Process characterization studies
- ICH-compliant cGMP stability program (intermediates, bulk drug substance, drug product and placebo)
- Cell-based bioassays