Quality Assurance Agreements: Supporting Your Compliance Needs

Navigating regulatory requirements in the Life Sciences industry demands a dependable approach to quality management. Our Quality Assurance Agreements (QAAs) are comprehensive, legally binding contracts designed to support your compliance needs and align with all major industry standards.

The Value of our QAAs

Our QAAs provide a structured framework to help you comply with applicable regulatory and legal requirements. They are more than just contracts — they outline essential processes and standards to ensure your products and services consistently meet and exceed industry expectations.

Key Features of our Quality Assurance Agreements

1. Comprehensive Quality Management System Standards and Certifications

Our QAAs align with industry-recognized certifications and standards, including:

• Pharmaceutical Good Manufacturing Practices (GMP)
• ICH Q7 for active pharmaceutical ingredients
• IPEC PQG GMP standards and EXCiPACT^® GMP certification 
• ISO certifications: ISO-9001, ISO-13485, and FSSC 22000
• EXCiPACT^® PAM certification for Cell Culture Media

These certifications demonstrate that your products are manufactured under stringent quality controls and requirements.

2. Comprehensive Support Services

Our QAAs ensure that you have a strong support system in place, covering:

• Complaint Handling: Clear processes to manage and resolve issues effectively.
• Audits: Structured protocols for conducting regular and unplanned audits.
• Corrective Actions: Defined procedures to address post-market quality communication robustly and promptly.
• Documentation Support: Access to best-in-class documentation and quality declarations for regulatory and data integrity compliance needs.

3. Proactive Change Notifications with M-Clarity™

With our M-Clarity™ Program, you receive timely updates regarding applicable changes impacting your products. This allows you to respond promptly and maintain compliance without disruption.

Our QAA Template: Industry-Standard and Pre-Approved

Our QAA template reflects best practices and standards established by BioPhorum, IPEC, APIC, and Rx360. It has been reviewed and approved by our legal team and affected internal quality teams, ensuring that it reflects quality requirements at our >50 manufacturing sites.

Highlights of Our Template:

• Tailored for High-Impact Products: Specifically designed for products within the Quality Segments of MQ300 and above, supporting the unique needs of controlled and regulated environments.
• Secure Information Management: All finalized agreements are stored in our dedicated IT system, ensuring secure documentation and robust implementation.
• Continuous Updates: Continuous review and updates to our template ensure compliance with current industry trends and regulatory requirements.

Commitment to Long-Term Compliance

Our QAAs are valid for five years, providing a stable compliance framework. We send a courtesy expiry notice before the term ends, ensuring ample time for renewal preparations and continued compliance. Periodic renewal of QAAs is a proactive way to stay compliant with the latest industry trends and regulations.

Partnering with us for Quality Assurance Agreements

Choosing our QAAs means choosing a dependable partner committed to your compliance needs. We provide the support, processes, and resources you need to maintain quality and regulatory standards. To learn more about how our QAAs can help support your compliance efforts and to request a QAA tailored to your raw material needs, please contact your local representative.