5 Top Tips for Calibration Success

Article By Darren Jones, Director & Senior Consultant for EPiC Auditors

Calibration is an often-overlooked area of the PQS; many calibration certificates are incorrect or don’t contain adequate detail and in many cases are not understood by the site experts!

Calibration services are frequently outsourced and I often find that key GMP decisions have also been inappropriately outsourced as well! Does the calibration company set the limits? Who determines how and when out of specification results are reported?

Many certificates do not state Pass or Fail… Why not? The certificates often just contain the limits and the data. I regularly find calibration results that do not comply with the limits- the calculations have not been done and no one in the Pharma company has checked the data!

Limits are sometimes specified as +/-2% of FSD (full scale deflection). What does this mean? Often the method of calculating this is not clear and the calculations used to determine this limit are not recorded or checked.

Given accurate instrumentation is key to achieving process control, which ultimately assures product quality, calibration requirements need to be understood and properly managed.

Tips for success:

1. Use multi-point calibration over the working range of the instrument.
2. Ensure you set, or at least approve the limits applied during calibration, don’t leave this just to the contractor.
3. Have a contract with the provider that includes instruments, frequency, limits, ranges and out of specification results reporting. Appendices containing tables can be useful to manage the detailed information.
4. Ensure results are reported as found and as left, i.e. pre and post any adjustment, you don’t want to miss a failed as found result.
5. Ensure limits are clearly understood. The SOP should show how to calculate limits e.g. based on FSD and these calculations should be documented and checked as per any other important calculation.  Evaluate the limits using Pass/Fail criteria.

If you need our help and support then please don’t hesitate to contact us.

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com

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We are delighted to announce that EPiC Auditors have won a place in Pharma Tech Outlook’s Top 5 Quality Assurance Services Companies in the UK 2022, the annual listing of 5 companies in the UK that are at the forefront of providing Quality Assurance services and transforming businesses in the region.

Specialising in performing mock inspections, GXP audits, supply chain and system audits, delivering bespoke training and supporting post-inspection remediation EPiC Auditors help clients achieve and maintain regulatory compliance.

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