Raw Materials Risk Mitigation And Management

By Marlin Frechette, Director, Regulatory Affairs and Quality Systems, Irvine Scientific

Protecting your raw materials is a vital part of your process – and one that should be taken seriously. Repercussions like plant shut-downs and drug shortages — stemming from events like virus contamination — can be far-reaching and difficult to overcome. To help safeguard your product and avoid potential adverse events, keep the following things in mind when sourcing media.

Raw Materials Handling

A proper raw material program provides a gateway of assurance for lot-to-lot consistency in finished goods. The critical principles built into our program incorporate the belief that the management of the raw material program and the supply chain is the foundation for high quality product.

The following raw material control principles are important to ensure consistency and quality:

• Sourcing of the Highest Grade Materials: High compendia-grade components assure purity and consistency of final product.
• Incoming Raw Material Testing and Inspection: Each raw material is different; therefore relevant incoming QC testing is a must. Every shipment of every raw material lot should be tested upon receipt, utilizing an acceptable statistical sampling plan. At very minimum, raw materials should be tested for identification, endotoxin, and moisture. Depending on the type and use, the raw material should also be tested for bioburden, enteric organisms, virus, and mycoplasma, at a minimum. You could also utilize a USP compendial test and/or relevant cell toxicity test.
• Animal Component-Free Raw Material: You can reduce viral contamination through the removal of animal-derived components. Transparency to a tertiary level allows understanding of the material and dictates handling.
• Continuous Supply Chain Management: This is a strategy that provides the ability to manage the supply chain towards transparency. Through this, you can foresee current and potential challenges with raw material supply to reduce future issues. Ongoing and proactive quality monitoring of suppliers provides better control and advances preparation for changes on the raw materials. Suppliers must be qualified, utilizing a risk-based approach with continuous improvement requirements via score cards reports.
• Dual Sourcing of Raw Material: Dual sourcing is a way to ensure supply continuity as a preventive measure to avoid production delays, and it also improves inventory management.
• Customer-Specific Raw Material Requirements: You have specific requirements for the handling of your critical raw materials. It's important that you utilize a system that supports handling of custom raw materials such as sourcing and/or specifications.

A high performing media is essential to the success of your program. Controlling this from prototyping, through scale-up or scale-down modeling, at troubleshooting, and finally, at production, requires the highest quality and rapid response. Your media is only as pure as the least pure ingredient. A stringent raw material program assures a final product that exceeds all quality requirements.

About Irvine’s Custom Media Program and Quality Systems:

Irvine’s custom media program is specified to your unique requirements, with communication being an essential factor every step of the way. Strong collaboration between suppliers and customers is a necessity, and we ensure that your questions and concerns are addressed — both during the order and after your product is received. Our organization is structured to provide customer accessibility to our key team members, and effective communication among all our internal departments. At Irvine Scientific, we strive for mutually beneficial long-term relationships while assisting you in completing your projects on-time. Irvine Scientific achieves lot-to-lot consistency through highly detailed manufacturing procedures, precise tolerances on all measures, and strict in-process acceptance ranges.

Our extensive history supporting regulated products assures our practices thoroughly conform to the International Standard Organization (ISO) and United States Food and Drug Administration (FDA) requirements. This knowledge is the foundation for our facility planning, comprehensive approach to validation, qualification and certification of methods, equipment, and processes.