The vaccine industry, as with most others, relies heavily upon raw materials. Considering the nature of vaccines and the type of raw materials, effective management is critical to prevent contamination. Marlin Frechette, Director, Quality Systems and Regulatory, Irvine Scientific joined us at the World Vaccine Congress Washington in 2012, to explain A Practical Approach to Raw Material Sourcing and Management. Take a look at the presentation and tell us what you think below. Do you agree with this method? Would you recommend another?
The Raw Material Program at Irvine Scientific has three fundamental principles: Operational Excellence (best practices), Quality Excellence (Continuous Improvement) and Service Excellence (Custom Requirements).
1. Operational Excellence
This principle takes into account industry best practices. There are several potential strategies, firstly, sourcing strategy (supply chain transparency is required). The baseline of this practical approach is the > 50% raw material components from manufacturers. From this number, Irvine attempt to further minimize the use of distributors where possible. Dual sourcing is another option, with the advantage of supply continuity, but a risk of mitigation-avoid delays. The baseline for this approach is 69% dual sourced and the aim to continue to qualify secondary sources. Finally, the supply chain approach, where the material and supplier qualification is split due to risk-based management.
2. Quality Excellence
This principle concerns the continuous improvement of the supply system to ensure quality excellence by: relevant incoming QC testing, vendor and material qualification, transparency to tertiary level and proactive analysis of new requirements.
3. Service Excellence
Seamless integration with custom needs makes for service excellence. Irvine achieves this through custom documentation requirements, inventory management and transparency to tertiary level.
The Raw Material Program ensures alignment with industry expectations, a practical approach to business and ensures execution.
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