Your Easy Guide to Clinical Studies

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:

• Staff qualification and training
• Sample workflow processes (e.g. process relevant SOPs/WIs)
• Biobank governance,
• Ethics requirements (e.g. EC, Declaration of Taipei), regulatory requirements (e.g. Swiss law), international standards (e.g. ISO)
• Database entry guidelines (e.g. BIMS)
• Safety guidelines for both donors, staff, and environment
• Facility management and maintenance guidelines
• The reporting and documentation of non-conformities (e.g. non-compliance)

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Define the processes of your biobank. Focus on:

• Organizational Requirements (e.g. reference to biobank regulation)
• Resource requirements (e.g. qualified staff, facilities, BIMS)
• Sample workflow requirements

 

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:

• Document risks management procedures in a SOP/WI, or in a project/study relevant Risk Assessment Form
• Plan additional QC risk control-measures, such as:
  • Internal biobank audits (e.g. SBP Quality Labels)
  • Management reviews

 

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

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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

References

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

Documents

• Risk Assessment Form for Clinical Research Projects