Quality Policy
BioCina is an Australian pharmaceutical contract manufacturer operating in Perth and Adelaide. Our manufacturing sites acknowledge and adhere to global Good Manufacturing Practices and Principles to ensure the Quality, Safety and Efficacy of the products we manufacture and the services we provide.
Our clients’ trust is earned through a phase-appropriate, quality-by-design approach that spans all stages of their program. This includes research, formulation and development, clinical trial evaluation, manufacturing scale-up, and concludes with drug product release and supply. Quality is core to every aspect of our services.
This Quality Policy outlines our quality mission, commitment, and culture for team members, visitors and appointed contractors.
Our Quality Mission
We rigorously uphold best practices across all business segments. Current Good Manufacturing Practice (cGMP) is a cornerstone of our business and organisational culture, ensuring quality and excellence in everything we do.
Our Quality Commitment
We are dedicated to manufacturing products that adhere to and are released in compliance with cGMP and the most stringent global regulatory standards.
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Quality Standards |
Provide clients with appropriate regulatory guidance and direction regarding quality standards and expectations to deliver superior products and services to market |
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Manufacturing |
Operate in accordance with the conditions of our regulatory licenses and permits |
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Finished Product |
Ensure products are manufactured and released in compliance with cGMP and regulatory standards |
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Compliance |
Quality shall utilise metrics, internal audits, and quality management review to verify the performance of the Quality Management System |
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Inspections & Audits |
Respond to Board of Health Inspections and client audits within the stated period |
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Continuous Improvement |
Our sites are committed to proactively evaluating opportunities to enhance our systems and processes, driving the continuous improvement of our service quality |
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Data integrity |
Always comply with Good Documentation Practices and data governance standards |
Quality Standards
Provide clients with appropriate regulatory guidance and direction regarding quality standards and expectations to deliver superior products and services to market
Manufacturing
Operate in accordance with the conditions of our regulatory licenses and permits
Finished Product
Ensure products are manufactured and released in compliance with cGMP and regulatory standards
Compliance
Quality shall utilise metrics, internal audits, and quality management review to verify the performance of the Quality Management System
Inspections & Audits
Respond to Board of Health Inspections and client audits within the stated period
Continuous Improvement
Our sites are committed to proactively evaluating opportunities to enhance our systems and processes, driving the continuous improvement of our service quality
Data integrity
Always comply with Good Documentation Practices and data governance standards
Our Quality Culture
Quality is a core principle of our culture, reflected in the actions and attitudes of every member of our organisation.
Our employees are empowered to uphold quality management systems, good manufacturing practices, and safety standards at all times.
Our leaders are committed to ensuring quality is embedded in every practice, action, and activity, taking responsibility and leading by example.
Signed 20th May 2025
Mark W. Womack
Chief Executive Officer
Melissa El Khouri
Head of Quality
Mark Weir-Smith
Head of Quality, Perth