What is it? Why is it important?

Quality Control (QC) is an integral part of a Quality Management System. An aspect of QC in biobanking is the definition and measurement of Quality-Control-Indicators. QC-Indicators are performance indicators regarding critical biobanking steps that must be monitored and controlled.


The performance of QC-indicators:

  • Allow for the ongoing monitoring of biobank operational processes
  • Indicate whether the compliance of Quality expectations are met
  • Feed into the implementation of biobanking improvement measures


QC-Indicators provide information on the compliance with:


Example: DNA/RNA in a biological sample

  • Aim: to ensure that DNA/RNA analytical results obtained at different time points are comparable
  • Requirement: to comply with ISO 20387 defining validated sample processing procedures for the preservation of tissue DNA and RNA.
  • QC-indicator: a minimal delta (e.g. to ensure elapsed time between sample collection and processing is less than 45 minutes)
  • QC-Indicator result: Calculated elapsed time between sample collection and processing
  • Documentation:
    • Time-lapse less than 45 minutes. QC-Indicator compliance
    • Time-lapse more than 45 minutes. Non-adherence to required QC-Indicator, and occurrence of non-conformity. Implementation of follow-up procedures (e.g. sample destruction)

What do I need to do?

Define the processes of your biobank. Focus on:


Establish risk-based QC-steps:

  • Defined QC-Indicators that must be complied with in order to ensure the quality of your biobank
  • In the event of non-conformity, plan applicable risk control-measures


According to your QC strategy:


Example of Biological Material (BM) QC-steps with defined QC-Indicators:

  • Cell viability: minimum % of viable cells required for analysis
  • Yield: minimum amount of total cells needed for diagnosis
  • Volume: minimum amount of collected BM (e.g. blood or serum) needed for analysis
  • Sterility: presence of non-contaminated cells


Examples of identified biobanking risks and the implementation of risk control-measures:

  • Facility and equipment:
    • Risks: freezer break-down, incorrect measurement of pipettes and scales, lack of processing solutions
    • Risk control-measures: freezer emergency plan, regular calibration of measuring equipment, regular inventory checks
  • Donor and staff safety:
    • Risks: staff exposed to toxic chemicals, lack of donor consent
    • Risk control-measures: staff trainings, implementation of safety procedures, and of informed consent procedures (e.g. documented in SOPs/WIs)
  • Data security:
    • Risk: accidental disclosure of data to the public, accidental deletion of data
    • Risk control-measures: BIMS with access control and audit trail

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

The Swiss Biobanking Platform (SBP) can provide you with support on this topic - see in particular

  • SBP Labels: Quality with biobanking best practice standards

SBP Documents

SOPs, Forms and Templates – see in particular

  • Quality control strategy implementation SOP
  • Quality control results
  • Risk management SOP


ISO 20387:2018 Biotechnology - Biobanking (access liable to cost)- General Requirements for Biobanking – see in particular section

  • 7.8 Quality control of BM and associated data
  • Quality management system requirements

Declaration of Taipei – see in particular principles

  • 1 – 7 Preamble


  • BIMS – Biobank Information Management System
  • BM – Biological Material
  • CTU – Clinical Trials Unit
  • DNA – Deoxyribonucleic acid
  • HrPD – Health-Related Personal Data
  • ISO – International Organization for Standardization
  • QC – Quality Control
  • QMS – Quality Management System
  • RNA – Ribonucleic Acid
  • SBP – Swiss Biobanking Platform
  • SOP – Standard Operating Procedures
  • WI – Working Instruction
Development ↦ Biobanking ↦ Quality Control ↦ Quality Control Indicators

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

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Ends after having assessed and evaluated study feasibility

Concept Drug or Device

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Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Biobanking ↦ Quality Control ↦ Quality Control Indicators

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