Commitment to Quality
in Sterile Manufacturing
Exceeding Industry Standards for Safe, Reliable, and High-Quality Sterile Injectables
A Strong Focus on Product Safety and Regulatory Excellence
At Afton Scientific, quality is not simply a requirement, it underpins everything we do. Every aspect of our sterile injectable manufacturing process is guided by robust quality control, regulatory compliance and a consistent commitment to patient safety. With a Quality Unit representing a significant proportion 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 High Standards
Our Quality Assurance programme incorporates multiple layers of oversight, including:
Regulatory Compliance and Oversight
Ongoing alignment with FDA, EMA, PMDA, and MHRA guidelines, supporting robust quality practices in line with evolving industry expectations.
Batch Release and Documentation
A thorough review process ensures compliance prior to product release, with full traceability at every stage.
Process Validation and Facility Qualification
Maintaining consistency and reproducibility through robust validation protocols for equipment, facility systems and manufacturing processes.
Data Integrity and Security
Full compliance with 21 CFR Part 11, supported by secure audit trails and backup systems to safeguard all GMP data.
Advanced Quality Control Laboratories
Our in-house Microbiology and Analytical Chemistry laboratories provide comprehensive testing services to uphold the highest standards of sterility and purity:
Microbiology Laboratory
-
Environmental Monitoring
Routine air, surface and personnel testing to detect potential contamination risks.
-
Water Quality Assurance
Bioburden, endotoxin, total organic carbon (TOC), and conductivity testing to ensure purified water meets strict compendial standards.
-
Sterility and Endotoxin Testing
Finished product sterility assessments to support complete contamination control.
Analytical Chemistry Laboratory
-
Raw Material and In-Process Testing
USP compendial testing, impurity profiling and residual solvent analysis.
-
Finished Product Testing
Assays using HPLC, GC, UPLC, and UV-Vis spectroscopy to verify product potency and purity.
-
Stability and Forced Degradation Studies
Long-term and accelerated stability programmes supporting formulation integrity over time.
-
Container Closure Integrity Testing (CCIT)
Ensuring product sterility throughout its shelf life.
Industry-Leading Validation and Continuous Improvement
We recognise that quality is an ongoing process rather than a fixed checkpoint. Afton Scientific has established proactive quality initiatives to support continuous improvement, including:
-
Ensuring our teams remain at the forefront of industry best practice.
-
Identifying and mitigating potential risks before they affect product quality.
-
Investing in next-generation quality control systems and cleanroom technologies.
Our regulatory inspection history demonstrates consistent success, including positive outcomes from FDA, MHRA, and PMDA audits with no critical observations. We continue to exceed compliance expectations and address any observations with a single, accepted response from regulatory authorities.