ISAC Regulatory Compliance 3

Question 1

In a GMP-compliant cell therapy manufacturing facility using flow cytometry for release testing, which document type specifies the acceptable ranges for each release parameter?

Accepted Answer

Product Specification document

Answer

A Product Specification document defines the predetermined acceptance criteria that a cell therapy product must meet on release testing, including flow cytometric parameters.

Question 2

Which validation element distinguishes 'verification' from 'validation' when a clinical lab adopts an FDA-cleared flow cytometry assay?

Accepted Answer

Verification confirms the lab can replicate manufacturer claims; validation establishes performance for a new intended use

Answer

For FDA-cleared assays, CLIA requires verification (confirming manufacturer performance claims), while full validation is required when the intended use or conditions differ from the cleared indication.

Question 3

A laboratory notices a systematic shift in CD4 counts after replacing a laser module. According to good laboratory practice, the FIRST action should be:

Accepted Answer

Perform a full analytical verification before resuming patient testing

Answer

Any hardware change affecting measurement quality requires a new verification of analytical performance before patient results can be reported.

Question 4

Under CAP Flow Cytometry Checklist requirements, how frequently must an operator perform and document instrument daily quality control before patient testing?

Accepted Answer

Each day of patient testing

Answer

CAP requires that daily QC be performed and documented each day patient specimens are analyzed to ensure instrument performance is within acceptable limits.

Question 5

The EU In Vitro Diagnostic Regulation (IVDR 2017/746) replaced the IVDD and introduced stricter classification rules. Under IVDR, most flow cytometry reagents used for patient diagnosis would likely fall into which risk class?

Accepted Answer

Class C (high risk, Notified Body review required)

Answer

Under IVDR, reagents used for serious or life-threatening disease diagnosis (e.g., oncology immunophenotyping) are typically Class C, requiring Notified Body conformity assessment.

(ISAC) International Society for the Advancement of Cytometry Practice Test

(ISAC) International Society for the Advancement of Cytometry Practice Test

ISAC Regulatory Compliance 3