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– Redipor product certificates, BMR’s and ERP

28/09/2020

Following communication sent on 23rd October 2019 regarding the ERP implementation in which we advised of a change in wording on our QC Certificates, we are now ready to start rolling out QC certificates from our ERP system. This will be a phased implementation over the next 3 months and includes some enhancements from the current certificate, as detailed below; Irradiated media generated from ERP by 31st October 2020 • A new work order number will be shown on the certificate, this relates to the product supplied. The batch number remains on the certificate for product traceability. • New ERP part number will be on certificates, current product code will remain on certificate titled ‘Old code’ • Irradiation dose product received will remain but will now include the acceptable tolerance Bottled media generated from ERP by 30th November 2020 • A new work order number will be shown on the certificate, this relates to the product supplied. The batch number remains on the certificate for product traceability. • New ERP part number will be on certificates, current product code will remain on certificate titled ‘Old code’ • Clarity on the sterility test reported Remaining products, including non-irradiated plates, sterile fill bags and ampoules generated from ERP by 31st December 2020 • A new work order number will be shown on the certificate, this relates to the product supplied. The batch number remains on the certificate for product traceability. • New ERP part number will be on certificates, current product code will remain on certificate titled ‘Old code’ • Clarity on the sterility test reported Changes that will be seen on certificates across all products: • The certificates will be renamed from Quality Control Certificates to Certificates of Analysis • A statement of conformity will now appear on the certificate, as follows: All our prepared media products are manufactured and tested at our site in Bicester, Oxfordshire under the control of our ISO9001:2015 approved quality management system. As part of the enhancement to the Certificates of Analysis, Batch Manufacturing Records (BMR’s) will no longer be supplied with certificates as of 1st November 2020. Certificates will continue to be distributed by email from Customer Support. Please do not hesitate to contact us is you have any concerns or queries regarding this change via quality@cherwell-labs.co.uk Yours sincerely Steven Brimble Quality Manager

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