Commitment to Quality
in Sterile Manufacturing
Exceeding Industry Standards for Safe, Reliable, and High-Quality Sterile Injectables
A Relentless Focus on Product Safety and Regulatory Excellence
At Afton Scientific, quality is not just a requirement—it is our foundation. Every aspect of our sterile injectable manufacturing process is driven by rigorous quality control, regulatory compliance, and a steadfast commitment to patient safety. With a Quality Unit representing a substantial percentage of our workforce, our Quality Assurance, Quality Engineering, and Quality Control teams ensure that every batch meets or exceeds global standards.
Comprehensive Quality Systems for Uncompromising Standards
Our Quality Assurance program integrates multiple layers of oversight, including:
Regulatory Compliance & Oversight
Continuous adherence to FDA, EMA, PMDA, and MHRA guidelines, ensuring robust quality practices that align with evolving industry expectations.
Batch Release & Documentation
A meticulous review process guarantees compliance before product release, with full traceability for every step.
Process Validation & Facility Qualification
Ensuring consistency and reproducibility through rigorous validation protocols for equipment, facility systems, and manufacturing processes.
Data Integrity & Security
Full compliance with 21 CFR Part 11, featuring secure audit trails and backup systems to protect all GMP data.
Advanced Quality Control Laboratories
Our in-house Microbiology and Analytical Chemistry Laboratories provide comprehensive testing services to uphold the highest sterility and purity standards:
Microbiology Laboratory
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Environmental Monitoring
Routine air, surface, and personnel testing to detect potential contamination risks.
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Water Quality Assurance
Bioburden, endotoxin, total organic carbon (TOC), and conductivity testing to ensure purified water meets strict compendial standards.
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Sterility & Endotoxin Testing
finished product sterility assessments for complete contamination control.
Analytical Chemistry Laboratory
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Raw Material & In-Process Testing
USP compendial testing, impurity profiling, and residual solvent analysis.
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Finished Product Testing
Assays using HPLC, GC, UPLC, and UV-Vis spectroscopy to verify product potency and purity.
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Stability & Forced Degradation Studies
Long-term and accelerated stability programs ensuring formulation integrity over time.
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Container Closure Integrity Testing (CCIT)
Ensuring product sterility throughout its shelf life.
Industry-Leading Validation & Continuous Improvement
We believe that quality is an ongoing process, not a static checkpoint. Afton Scientific has established proactive quality initiatives to drive continuous improvement, including:
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Ensuring that our teams remain at the forefront of industry best practices.
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Identifying and mitigating potential risks before they impact product quality.
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Investing in next-generation quality control systems and cleanroom technologies.
Our history of regulatory inspections speaks for itself, with successful FDA, MHRA, and PMDA audits and no critical observations. We consistently exceed compliance expectations and resolve any observations with a single response accepted by regulatory bodies.