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Changes to the Certificates of Analysis to be in effect October/2018


Question:

What are the changes to the Certificates of Analysis?


Answer:

There are two categories of changes; one for Chromatography resins and one for Ceramic Apatite resins.

  • Chromatography resins
    1. The current wet signature is to be replaced with an electronic signature by Quality Assurance as well as date/time stamp in compliance with 21 CFR Part 11.
    2. We will no longer provide a printed copy of CofA with shipments.
    3. Customers will be able to download an electronic copy of the CofA at www.bio-rad.com by providing the product catalog and control numbers.

  • Ceramic Apatite resins
    1. The FTIR spectrum and protein separation chromatogram will be removed from the CofA. Customers will be able to obtain copies of the data per request by contacting your local Bio-Rad support team. The following statement will be added to the CofA: “The FTIR spectrum and Protein Separation chromatogram are available upon request by contacting your local Bio-Rad support team”.
    2. The current wet signature is to be replaced with an electronic signature by Quality Assurance as well as date/time stamp in compliance with 21 CFR Part 11.
    3. We will no longer provide a printed copy of the CofA with shipments.
    4. Customers will be able to download an electronic copy of the CofA at www.bio-rad.com by providing the product catalog and control numbers.

Why are these changes being made?
These format modifications are intended to standardize the formats of our Certificates of Analysis across our portfolios and to improve our Customers’ experience.

When will these changes become effective?
These changes plan to go into effect no sooner than October 10th, 2018.

Will these changes affect the product name or item number?
No, product name and item number will not be affected.

A PDF document describing these Changes to Bio-Rad’s Certificates of Analysis that includes samples of the new formats is available.


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