Introducing MatRisk™ for Material & Supplier Management
ProDeMaCon's Proprietary Toolbox
ProDeMaCon’s proprietary MatRisk™, our phase-appropriate Material & Supplier Management system, has already been successfully implemented at several CGT companies and CDMOs. Whether you are in early development or already in pivotal trials, it’s crucially important to plan for proper raw material onboarding & qualification while ensuring continuity of supply. Your Pharma, Biotech or Cell&Gene business depends on it.
For more information on the importance of proper Material & Supplier Management in Biotech, Cell&Gene, refer to our recently published article:
Best Practices For Raw Material And Supplier Management For Cell & Gene Therapy Manufacturing By Andreas M. Beckhaus and David J. Cady
Contact us for more information on MatRisk™.
Benefits
- Ready-to-implement toolbox
- Can be customized to your needs
- All necessary activities according to your project’s development phase
- Includes key SOPs and assessment & documentation forms
- Saves you thousands of FTE hours
- Ensures compliance for each stage of development
- Risk-based approach with fully documented justifications
- Prepares you for regulatory submissions and audits
Ensuring uninterrupted supply during development and commercial phases
The Supply Continuity tool of MatRisk™ will assess the available capacity, regulatory/quality maturity, and financial health of your suppliers. It will also assess for each raw material (excipients, primary containers, starting materials such as vectors, reagents, buffers, single-use components etc.):
- the strategic fit (i.e., relative importance of your business based to the supplier based on their profile analysis)
- the ease of sourcing (i.e., difficulty of sourcing and qualifying an additional supplier)
- the sourcing diversification (i.e., how many supplier sites are available and/or qualified)
- the quality audit & compliance status
- the supplier quality history score and on-time performance score
This lets you easily prioritize your critical materials and suppliers in order to take appropriate actions such as SRM (Supplier Relationship Management), Inventory management, alternative sourcing etc.
Phase-appropriate raw material onboarding and qualification
The raw material assessment form of the MatRisk™ toolbox is a living form that documents the phase-appropriate risk assessment for each material used in GMP production, considering among others:
- Potential impact on the final drug product's SISPQ (Safety, Integrity, Strength, Purity, Quality)
- Material qualification status and vendor data
- Supplier risk/status
- Material sterility assessment
- Adventitious / viral agents and TSE risk assessment
- Material particulates assessment
- Material stability assessment
- Material E & L and adsorptivity assessment
- Other additivity assessments (residual solvents, elemental impurities etc.)
- Manufacturer's specification appropriateness
At the end, potential Critical Material Attributes are determined for your Material Qualification as well as other attributes where you may rely on manufacturer testing.
Material testing and release specification
Based on the draft Critical Material Attributes from the initial risk assessment, a testing plan is put together for your Material Qualification to transition from clinical specification to commercial specification.
Test results (typically from 3 different material batches) are documented and evaluated (e.g., by comparing your results with the manufacturer's CoA) in the Material Qualification form, which will serve as the justification for your commercial specification.
All key SOPs and Policies you need for compliant Material & Supplier Management
The SOP and policy templates from the MatRisk™ toolbox can easily be adapted and implemented according to your needs. They specify all necessary activities for material and supplier management phase-appropriately over the life cycle of the product. They work in conjunction with the other tools of the MatRisk™ toolbox.
Additional forms you need for compliant Material & Supplier Management
Additional complementary template forms from the MatRisk™ toolbox include:
- Material Specification Form
- Material Disposition Form
