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

Standard Operating Procedure (SOP)

Answer

Certificate of Analysis (CoA)

Answer

Deviation Report

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

Validation is required only for LDTs; verification is required for all tests

Answer

Verification requires FDA submission; validation does not

Answer

They are synonymous under CLIA regulations

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

Report the shift to the FDA as a device malfunction

Answer

Adjust the normal reference ranges to match the new results

Answer

Discard all results from the prior month

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

Weekly, with monthly review by the laboratory director

Answer

Monthly, using a six-point calibration curve

Answer

Annually, coinciding with proficiency testing cycles

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

Class A (lowest risk, self-declaration)

Answer

Class B (moderate risk)

Answer

Class D (highest risk, batch release required)

Question 6

Which element is NOT typically required in a flow cytometry laboratory's Quality Management System (QMS) under ISO 15189?

Accepted Answer

Manufacturer profit margin disclosures

Answer

Document control procedures

Answer

Personnel training and competency records

Answer

Management review meetings

Question 7

When shipping patient-derived specimens for flow cytometry analysis by a reference laboratory, which US regulation governs the packaging and labeling of the biohazardous material?

Accepted Answer

DOT 49 CFR Part 173 — Shippers General Requirements for Shipments and Packagings

Answer

OSHA 29 CFR 1910.1030 — Bloodborne Pathogens Standard

Answer

FDA 21 CFR Part 58 — Good Laboratory Practice

Answer

EPA 40 CFR Part 261 — Hazardous Waste Identification