Our Quality Record
A Record of Quality and Compliance
Delivering Excellence in Aseptic Manufacturing
For more than 20 years, Afton Scientific has been a trusted name within the industry, consistently maintaining high standards in sterile injectable manufacturing. Our robust quality assurance practices, ongoing improvement initiatives and strong regulatory compliance ensure that every product we manufacture meets the most demanding industry requirements. Clients rely on Afton Scientific to deliver safe, effective and compliant drug products that support patient safety and regulatory integrity.
Regulatory Compliance and Certifications
Afton Scientific operates in full compliance with leading global regulatory authorities, including:
FDA (U.S. Food and Drug Administration)
A strong record of successful inspections and approvals.
EMA (European Medicines Agency)
Ensuring alignment with European regulatory requirements.
MHRA (UK Medicines and Healthcare Products Regulatory Agency)
Reflecting a commitment to both UK and global compliance standards.
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
Maintaining high regulatory standards for international markets.
Health Canada
Supporting regulatory compliance for North American clients.
Our facilities operate in accordance with cGMP standards and adhere to ISO guidelines and data integrity requirements, ensuring product safety, reliability and traceability at every stage.
Our Commitment to Quality
Quality underpins every aspect of our operations at Afton Scientific. Our robust Quality Management System (QMS) reflects our commitment to continuous improvement, rigorous regulatory compliance and the adoption of advanced technologies. With a strong regulatory track record and a history of successful inspections, we provide our clients with confidence, delivering consistent quality in every batch.
Aseptic Processing and Manufacturing Excellence
Afton Scientific’s manufacturing processes are designed to ensure the highest levels of sterility and effective contamination control. Our facilities utilise single-use systems and technologies, supporting enhanced sterility assurance throughout fill/finish operations. We apply comprehensive environmental monitoring to preserve cleanroom integrity and prevent contamination at every stage of production. Batch records are carefully maintained, and real-time quality monitoring enables us to verify the integrity of each product before release.
By integrating these technologies and best practices, we provide clients with confidence in the safety, efficacy and regulatory compliance of their drug products.
A Culture of Continuous Improvement and Customer-Centricity
We continue to invest in technology, automation and training to enhance our manufacturing processes, supporting efficiency, compliance and high standards of product quality. Our focus includes:
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Supporting proactive quality control and the prevention of potential issues.
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Applying the latest industry developments to stay ahead of regulatory changes.
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Ensuring our team remains at the forefront of aseptic manufacturing best practice.
In addition to maintaining high technical standards, we place a strong emphasis on transparency and collaboration with our clients.
Our client-focused approach ensures that each project benefits from tailored quality solutions designed to meet specific requirements. With a well-established track record, we develop long-term partnerships built on trust, reliability and shared quality objectives.