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Enhanced Quality Profile Overview Our Offer - Diagnostics Change in manufacturing may not always be desired, but changes will happen due to a variety of factors, both planned and unplanned. However, it is the desire of SAFC to minimize the impact to our customers and act as a partner when these situations arise. SAFC has a defined Management of Change process in-place, using a multi-tiered Quality Assurance program to assist our partners at better managing the risk of any potential change. The SAFC Change Control Notification (CCN) program links our partners with the SAFC Quality Assurance change management process. Those partner customers who have submitted a formal request for inclusion in the SAFC Change Control Notification program would be notified in writing for specific areas of potential change. (see table below for details) The level of change control notification is dependent upon which tier a specific product has been classified. Description Standard Tier Premium Tier Elite Tier cGMP / Compendia Custom Sourcing Internal or External Internal or External Internal Internal Internal Product Use Research Research or Raw Material Raw Material API, BPE, IVD Raw Material to Final Product Quality System Controls ISO 9001:2000 ISO 9001:2000 ISO 9001:2000 with Elements of ICH, EDQM 21CFR, ICH Q7A, ISO 13485:2003, EDQM, IPEC ISO 9001:2000 thru cGMP Certificate of Analysis Available Available Available Available Per Customer Requirements Expiry or Recommended Retest Date No Available Available Available Per Customer Requirements Certificate of Origin Upon Request Available Available Available Per Customer Requirements Lot Sample Retain No Upon Request Available Available Available Analytical Method If not on Website, Available on Request If not on Website, Available on Request If not on Website, Available on Request Available Only with Non-Disclosure Agreement Including Raw Data, Proprietary to Specific Customer Only with Non-Disclosure Agreement Change Control Notifications Product Deletion Available Available Available Available Available Source of Supply No Available Available Available Available Manufact-uring Location No No Available Available Available Raw Material Specifications No No Available Available Available Process Aids No No Available Available Available Process No No Available Available Available Scale No No Available Available Available Analytical Testing Test method Upon Request Upon Request Available Available Available Specification Upon Request Available Available Available Available Packaging Components No Upon Request Available Available Available Storage Conditions Upon Request Upon Request Available Available Available Recall, Alert Available Available Available Available Available Description Standard Tier Premium Tier Elite Tier cGMP / Compendia Custom