Our Quality Record
A Legacy of Quality and Compliance
Achieving Excellence in Aseptic Manufacturing
For over 20 years, Afton Scientific, a trusted name in the industry, has upheld the highest quality standards in sterile injectable manufacturing. Our rigorous quality assurance practices, continuous improvement initiatives, and unwavering regulatory compliance ensure that every product we manufacture meets the most stringent industry requirements. Customers trust Afton Scientific to deliver safe, effective, and compliant drug products that uphold patient safety and regulatory integrity.
Ensuring Patient Safety – Navigating Regulatory Guidelines for Aseptic Drug Filling
Regulatory Compliance & Certifications
Afton Scientific operates in full compliance with the world’s leading regulatory agencies, including:
FDA (U.S. Food and Drug Administration)
Over 20 years of CBER and CDER inspections and approvals.
EMA (European Medicines Agency)
Ensuring commitment to Annex 1.
MHRA (UK Medicines and Healthcare Products Regulatory Agency)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
Routine commercial inspections since 2019.
Health Canada
Ensuring seamless compliance for North American clients
Our facilities are cGMP-compliant and adhere to ISO and ANNEX 1 guidelines and data integrity standards, ensuring product safety, reliability, and traceability at every stage.
Our Commitment to Quality
Quality is embedded in every aspect of our operations. Our mature Quality Management System (QMS) integrates continuous improvement initiatives, rigorous regulatory compliance, and cutting-edge technology. With a strong regulatory track record and successful FDA, PMDA, and Health Canada drug filings, we give customers confidence and excellence in every batch.
Aseptic Processing & Manufacturing Excellence
Afton Scientific’s manufacturing processes are designed to ensure the highest levels of sterility and contamination control. Our Fill-Finish facilities use single-use processes and technologies, enhancing sterility assurance during fill/finish operations. We implement comprehensive environmental monitoring to verify cleanroom integrity. Detailed Batch records and real-time quality monitoring allows us to ensure the integrity of every product before it leaves our facility. By integrating these technologies and best practices, we provide customers with confidence in their drug products’ safety, efficacy, and regulatory compliance.
Read: Navigating Sterile Injectable CMO Selection – A Technical and Quality Assessment
A Culture of Continuous Improvement and Customer-Centricity
We continuously invest in technology, automation, and training to enhance our manufacturing processes, ensuring efficiency, compliance, and superior product quality. Our focus includes:
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Enabling proactive quality control and issue prevention.
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Implementing the latest industry advancements to stay ahead of regulatory changes.
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Ensuring our team remains at the forefront of aseptic manufacturing best practices.
With a proven track record of success, Afton builds lasting partnerships based on trust, reliability, and shared quality objectives.