Reference Standards

Pharmaceutical reference standards are essential for ensuring the quality, safety and efficacy of pharmaceuticals. These meticulously characterized materials serve as benchmarks for analytical testing, enabling manufacturers to verify the identity, purity and potency of active pharmaceutical ingredients (APIs) and drug products. Regulatory requirements include specific guidelines for their qualification, documentation, traceability and compliance with agencies, such as the FDA, EMA and ICH.

The Importance of Reference Standards in Pharmaceuticals

1. Ensuring Product Quality – Reference standards provide validated benchmarks for analytical testing, impurity profiling and stability studies. By leveraging these standards, manufacturers can ensure the consistency and safety of their drugs, meeting stringent quality requirements demanded by regulatory agencies and the industry.
2. Supporting Regulatory Compliance – Regulatory agencies mandate robust documentation and traceability for reference materials. Properly qualified standards are essential for regulatory filings, including INDs, NDAs and post-approval submissions, ensuring compliance with global guidelines and reducing risks associated with delays or rejections.
3. Facilitating Manufacturing Efficiency – They play a pivotal role in assessing the impact of changes to manufacturing processes. By providing accurate and reliable data, they enable manufacturers to address challenges swiftly, optimize production workflows and maintain operational efficiency throughout the drug lifecycle.

Precision in Practice: Cambrex’s Proven Strategy for Reference Standards Qualification

Cambrex combines decades of experience, advanced systems and a collaborative approach to develop, qualify and store high-quality reference standards tailored to the unique needs of each client. Our capabilities include:

• Expertise in Analytical Development and Qualification – Cambrex’s integrated analytical services and chemical development teams excel in developing and qualifying standards for APIs, intermediates and impurities. With deep knowledge of regulatory guidelines, we ensure that every standard meets the highest quality benchmarks required for compliance and manufacturing success.
• Advanced Systems – Cambrex employs a state-of-the-art laboratory information management system (LIMS) to efficiently characterize, store and monitor reference materials. This integrated approach ensures traceability, stability and authenticity – minimizing risks and maximizing reliability.
• Full Regulatory Support – We provide detailed documentation, including certificates of analysis (COAs) and thorough experimental reports prepared to support regulatory filings. Our expertise in global regulatory requirements ensures that clients can navigate compliance challenges with confidence and ease.
• Collaborative Problem-Solving – At Cambrex, process chemists and analytical teams work side by side to address complex manufacturing challenges. Whether it’s impurity characterization, stability concerns or synthesis/resupply, our integrated approach delivers actionable solutions to keep your project on track and ensure the highest quality.

A Differentiated Approach: Cambrex’s Reference Standard Strategic Management (RSSM) Program

Our Reference Standard Strategic Management (RSSM) program offers a comprehensive solution for the management and distribution logistics required of reference standards, enabling clients to focus on their core manufacturing processes with confidence. With a dedicated team within our analytical services group, we offer white-glove, full-service lifecycle management of reference standards, including the following:

• GMP Management – we provide repository support for GMP materials, ensuring compliance with stringent regulatory standards (21CFR210/211).
• Validated Stability Storage – reference standards are stored in validated, temperature-mapped, and continuously monitored conditions, ranging from standard ICH to ultra-low temperatures down to -70 °C.
• Safe and Secure Solutions – our service includes provisions for highly potent compounds and controlled substances.
• End-to-End Analytical Support – we cover all method onboarding, including method development, if required, and qualification of material structure, identity, potency and purity, ensuring reference standards meet regulatory and scientific requirements.
• Fractionation, Inventory Reporting & Distribution – we support fractionation, detailed inventory reporting and worldwide distribution of reference standards to maintain complete traceability and efficiency.
• Integrated Services for Impurity and Material Characterization – our chemical development team handles synthesis/resupply activities of reference materials while our analytical team performs the structural characterization, isolation and identification of impurities to ensure the highest quality and reliability for your reference standards.
• Lifecycle Management – our program includes requalification and periodic retesting of reference standards to ensure they remain compliant and meet ongoing program needs.