FDA Guidance: Computer Crossmatch, 4/11

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April 2011 FDA Guidance for Industry: Computer Crossmatch (Computerized Analysis of the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type)
“Computer Crossmatch” is a process used to ensure that blood released for transfusion is compatible with the intended recipient.

The FDA issued this guidance to assist blood establishments performing compatibility testing using a computer crossmatch system in complying with the current good manufacturing practice (CGMP) requirements in 21 CFR Parts 210, 211 and 606.

Computer crossmatch requires a high degree of testing and validation to ensure accuracy. Pay particular attention to:

• Section IV Crossmatch Program Elements: data entry and verification, required data elements, decision table configuration, software generated warning messages, procedures for use during computer downtime
• Section V Validation and Revalidation: validation requirements, validation protocol elements, revalidation requirements
• Section VI Records: record retention, including crossmatch records, validation, revalidation