ALL RAW MATERIALS ARE NOT CREATED EQUAL.

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1 ALL RAW MATERIALS ARE NOT CREATED EQUAL. Meet Diagnostics Elite DIAGNOSTIC SOLUTIONS Reimagine what s possible.

2 REDUCE RISK. INCREASE CONSISTENCY. The Diagnostics Elite program is more than just a set of raw materials. It is an investment in your future product security. Diagnostics Elite Program Attributes: Increased control over manufacturing processes to ensure consistent product performance Enhanced change control notification Supply chain control and transparency Extensive documentation to meet current requirements Elevated quality and supply chain support We understand that developing and manufacturing IVD assays is a complex process involving critical raw materials that can affect assay performance. We also recognize that IVD industry regulations are complex and evolving. In such an environment, small inconsistencies in raw materials can lead to significant disruptions in assay design, delays in manufacturing, and affect assay performance. It is why we have developed Diagnostics Elite, an enhanced portfolio of raw materials that promotes consistency across your entire assay manufacturing process. Every Diagnostics Elite raw material is designed with a focus on improving manufacturing efficacy while minimizing your level of risk. TYPES OF RISK IN IVD MANUFACTURING COST RISK MANAGEMENT $$$$$ Product recall $$$$ $$$ Backorder Patient misdiagnosis or patient harm $$ Delay in manufacturing Batch failure $ SEVERITY Sigma-Aldrich Corporation The Diagnostics Elite Program 2

3 THE DIAGNOSTICS ELITE ADVANTAGE. With the Diagnostics Elite program, we have leveraged our knowledge of the IVD industry, regulations and customer requirements and merged these with our expertise in quality and supply chain enhancements to provide you the level of transparency needed throughout the product s lifecycle. As part of the Sigma-Aldrich Enhanced Quality Program, Diagnostics Elite products are categorized by intended use, requirements for documentation, supply chain transparency and other quality attributes. With a better understanding of these raw material attributes, you can effectively align your raw material plans with our offering. STANDARD PRODUCTS VS DIAGNOSTICS ELITE PRODUCTS Key Attributes of the Diagnostics Elite Products Quality by design - Failure modes and effects analysis (FMEA) and critical control parameters - QA batch reviews Increased consistency - 12 week change control notification - Vendor management for raw materials and finished goods Enhanced service - Retained batch samples - Higher priority for quality complaints and investigations Optimized products - Additional specifications for intended applications - Stability data for GMP products SIGMA-ALDRICH ENHANCED QUALITY GUIDELINES Diagnostics Elite Products Attributes Product Use Raw Material Regulatory Requirements Standard Research, Industrial and Chemical Specialities Non-Regulated Applications Premium Research, Industrial and Chemical Specialities Non-Regulated Applications Quality Systems Controls ISO 9001 ISO 9001 Sourcing Information Analytical Methods Certificate of Analysis Change Control Notification Product Specification Certificate of Origin Expiry or Retest Date Vendor Assessment Critical Control Parameter (CCP) QA Batch Review Lot Sample Retained Vendor Management Validation Proprietary Discretionary Confidential Information Shared Under CDA Elite IVD Manufacturing and Biopharma Processing Regulated Applications ISO 9001 plus other Controlled Processes Confidential Information Shared Under CDA GMP/Compendia API, BPE, IVD, Biopharma Applications Regulated Applications ICH Q7, IPEC, 21 CFR, Confidential Information Shared Under CDA For more information, visit sigma-aldrich.com/diagnostics 3

4 CONSISTENCY AND TRANSPARENCY Change Control Notification Program Our commitment to maintaining consistent manufacturing processes for Diagnostics Elite and GMP products. We understand that changes in critical raw material may require an IVD manufacturer to perform extensive impact analysis and validation. To reduce this risk and communicate changes in a timeframe that would limit the impact to commercialization, we have implemented advanced change control for Diagnostics Elite and GMP products. When changes are unavoidable, we are committed to providing you with advanced notification as quickly as possible. See Notifiable Events below for more details. EXAMPLE NOTIFIABLE EVENTS AND TIMEFRAMES Notifiable Events Standard Premium Elite GMP Expiry or Recommended Retest Date Immediate Immediate Immediate Immediate Storage Temperature Immediate Immediate Immediate Immediate EQP Status Downgrade N/A Immediate Immediate Immediate Product Recalls and Alerts Immediate Immediate Immediate Immediate Product Master Data (Examples- Name, Formula weight, CAS#, etc.) Immediate Immediate Immediate Immediate Label Changes (Examples- CAS, Formula, Storage Temp, Weights) Immediate Immediate Immediate Immediate Procured Product: Country of Origin (if known) 2 weeks 4 weeks 12 weeks 12 weeks Vendor (company we place our PO with) 2 weeks 4 weeks 12 weeks 12 weeks Country of Origin - in house manufactured 2 weeks 4 weeks 12 weeks 12 weeks Manufacturing Site in house manufactured 2 weeks 4 weeks 12 weeks 12 weeks Analytical Release Specifications and/or Methods 2 weeks 4 weeks 12 weeks 12 weeks Site - Packaging 2 weeks 4 weeks 12 weeks 12 weeks Site - Finished Product Testing Laboratory 2 weeks 4 weeks 12 weeks 12 weeks Primary Packaging Materials (only catalogue packaging not applicable to custom packaging) Timeline of Notification Prior to Change Diagnostics Elite Products N/A 4 weeks 12 weeks 12 weeks Country of Origin (Procured items) N/A 4 weeks 12 weeks 12 weeks Shipping and Handling N/A 4 weeks 12 weeks 12 weeks Type of Manufacture N/A 4 weeks 12 weeks 12 weeks Biologic country of origin for Starting Material (animal sourced only) N/A N/A 12 weeks 12 weeks Manufacturing Site - Procured N/A N/A 12 weeks 12 weeks Significant Manufacturing Process Changes N/A N/A 12 weeks 12 weeks For more information, visit sigma-aldrich.com/diagnostics 4

DIAGNOSTICS ELITE PRODUCTS ON SIGMA-ALDRICH.

to go. Use these few simple tips and Diagnostics Elite products are a click away.

When you see this statement under Price and Availability, this is a clear indicator that we have the product you are looking for in Elite or GMP grade.

5 DIAGNOSTICS ELITE PRODUCTS ON SIGMA-ALDRICH.COM When one of our standard or premium products have a Diagnostics Elite or GMP version available, finding it through our product detail pages is the way to go. Use these few simple tips and Diagnostics Elite products are a click away. Diagnostics Manufacturers and Clinical Labs should use alternative grade product. When you see this statement under Price and Availability, this is a clear indicator that we have the product you are looking for in Elite or GMP grade. Below the pricing and availability you will see an Elite grade ad (left). Clicking on this ad will take you to the corresponding Elite grade product. Diagnostics Elite (Elite or GMP) grade products can be identified by their designation as Suitable for manufacturing of diagnostic kits and reagents. The quality level listed in the properties will also denote Elite or GMP. Sigma-Aldrich Corporation Diagnostics Elite 5

6 COLLABORATION WITH PURPOSE. DIAGNOSTICS ELITE PROCESS AND THE EARLY ACCESS PROGRAM As the Diagnostics Elite program continues to expand, we work diligently to align new optimized products with your evolving needs. One of the ways we do this is through the Early Access Program (EAP). Through this program we provide the opportunity for participating customers to collaborate with us to select and design specifications of new Diagnostic Elite products. The EAP provides participating partners with exclusive access to new Diagnostics Elite products and offers the opportunity for testing and feedback. We will help you minimize the cost and time associated with qualifying our raw materials by gaining a better understanding of how they are used in your products. Our goal is to deliver consistent, high-performing products in alignment with your needs. NEW PRODUCT SELECTION/INITIATION RISK ASSESSMENT & DOCUMENT CREATION QUALIFICATION COLLABORATE THROUGH THE EARLY ACCESS PROGRAM Select products based on customer priorities - Raw materials for new kits - Critical raw materials for existing kits Influence enhanced product specifications Influence format and configuration Joint review of risk factors based on intended product use and required documentation Coordination of manufacturing and testing schedules Feedback of product performance To request more information about our Early Access Program, go to sigma-aldrich.com/diagnosticselite Enabling Science to Improve the Quality of Life Order/Customer Service: sigma-aldrich.com/order Technical Service: sigma-aldrich.com/techservice Development/Custom Manufacturing Inquiries safcglobal@sial.com Safety-related Information: sigma-aldrich.com/safetycenter World Headquarters 3050 Spruce St. St. Louis, MO (314) sigma-aldrich.com 2015 Sigma-Aldrich Co. LLC. All rights reserved. SIGMA, SAFC, SIGMA-ALDRICH, ALDRICH and SUPELCO are trademarks of Sigma-Aldrich Co. LLC, registered in the US and other countries. FLUKA is a trademark of Sigma-Aldrich GmbH, registered in the US and other countries. Sigma-Aldrich, Sigma, Aldrich, Supelco, Fluka and SAFC brand products are sold by affiliated Sigma-Aldrich distributors. Purchaser must determine the suitability of the product(s) for their particular use. Additional terms and conditions may apply. Please see product information on the Sigma-Aldrich website at and/or on the reverse side of the invoice or packing slip. RVQ

Importance of ICH Guidance in Fulfilling Process Validation Requirements

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