ACCREDIA and on-site calibration for pharma

In breve

An ACCREDIA-accredited calibration is issued by a LAT centre accredited according to ISO/IEC 17025 and guarantees internationally recognized traceability and uncertainty. Not all instruments require it: it is needed for the reference standards and the most critical parameters. On-site calibration, instead, performs the checks directly on the shop floor, maintaining traceability through reference standards calibrated at a LAT centre.

Accredited calibration: what it really means

"ACCREDIA-accredited" is not a generic quality seal: it means that a LAT centre (Accredited Calibration Laboratory) operates according to ISO/IEC 17025, with an accreditation scope that defines exactly for which quantities and measurement ranges it can issue recognized certificates (temperature, pressure, mass, humidity, flow, etc.). The LAT certificate declares the uncertainty and the traceability chain up to the national standards (in Italy, INRIM).

Beware of a frequent confusion: a company can use ACCREDIA-accredited calibrations without being a LAT centre. The distinction counts in an audit and must be declared precisely.

When accredited calibration is needed (and when not)

Not all the instruments in a site require a LAT certificate. The logic is hierarchical:

Reference standards and the most critical measuring instruments → an accredited LAT calibration is preferable, as it sets the apex of the site's traceability chain.
Field instrumentation → can be calibrated internally or on-site against standards that are in turn calibrated at a LAT, with traceability nonetheless guaranteed.

The opposite error — demanding an accredited certificate for every single instrument — is costly and often not required: what counts is that the traceability chain be documented and unbroken, as explained in the guide to GMP metrological management.

On-site calibration: why it makes sense in GMP

Taking instruments out of the site for calibration means downtime, handling and risk. On-site calibration (on site, on board) performs the checks directly on the shop floor, with reference instrumentation transported by the technician. Typical advantages in a pharmaceutical site:

less plant downtime: the instrument does not leave the line more than necessary;
real conditions: the instrument is calibrated in its environment of use;
maintained traceability: the standards employed are calibrated at ACCREDIA-accredited laboratories, so the on-site certificate is traceable;
documentary integration: the outcome flows immediately into the schedule and the audit trail of the metrological system.

The condition for on-site calibration to be defensible is always the same: documented traceability and procedures adequate to the parameter and the required uncertainty.

How to choose the supplier

For the calibration of the instrumentation of a GMP site, elements to verify:

traceability guaranteed through ACCREDIA-accredited laboratories for the parameters you need (with verifiable scope and certificates);
on-site capability with adequate reference instrumentation;
certificate management and integration with the schedule;
management of Out of Tolerance cases with an impact assessment, not just recalibration;
experience in the regulated pharmaceutical sector.

The Eurosystem approach

Eurosystem has managed the calibration of the critical instrumentation of pharmaceutical sites since 1990, performing the checks on-site and maintaining the metrological traceability of its own reference standards and of those of its customers through ACCREDIA-accredited laboratories. The outcome flows into the Dimacs platform, with which we keep schedules, certificates and Out of Tolerance cases of over 11,000 instruments under control. We are not a LAT centre: we are the partner that manages the site's entire metrological system, guaranteeing its traceability.

Domande frequenti

What does ACCREDIA-accredited calibration mean?

It means that the certificate is issued by a LAT centre accredited by ACCREDIA according to ISO/IEC 17025, with a scope that defines the quantities and measurement ranges covered. The certificate declares the uncertainty and the traceability up to the national standards (INRIM in Italy) and is internationally recognized thanks to the mutual recognition agreements.

Must all instruments have an accredited LAT calibration?

No. Accredited LAT calibration is typically reserved for reference standards and the most critical parameters, which set the apex of the traceability chain. Field instrumentation can be calibrated against standards that are in turn calibrated at a LAT, maintaining traceability without an accredited certificate for every single instrument.

How does on-site calibration work in pharma?

The technician performs the checks directly on the shop floor with transported reference instrumentation, calibrated at ACCREDIA-accredited laboratories. This reduces plant downtime, calibrates the instrument in its real conditions of use and maintains the traceability of the certificate, with the outcome integrated immediately into the schedule and the audit trail of the metrological system.

Must a company be a LAT centre to guarantee ACCREDIA traceability?

No. A company can guarantee traceability by using reference standards calibrated at ACCREDIA-accredited laboratories, without being a LAT centre itself. It is an important distinction to declare precisely: what counts for the audit is that the traceability chain be documented and unbroken.

Do you need an ACCREDIA-accredited calibration centre for pharma?

You need it for reference standards and for the most critical quantities, which set the top of the traceability chain. For plant instruments, calibration by comparison with those standards is sufficient, provided the chain is documented. The right choice is a partner that manages the whole metrology system and relies on LAT centres for the standards: the model Eurosystem applies to more than 11,000 instruments.

What does an on-site calibration service for pharmaceutical companies include?

Planning on the calibration schedule, intervention in the plant with ACCREDIA-traceable portable standards, calibration under real operating conditions, a certificate with uncertainty and acceptance criterion, immediate handling of Out of Tolerance events and recording in the metrology system with an audit trail. The benefit is minimal downtime and inspection-ready documentation.

What is the difference between in-house and external accredited calibration?

In-house calibration is performed by the site or its metrology partner with its own traceable standards: it covers field instruments and is fast and integrated in the schedule. External accredited calibration is issued by a LAT centre with an ACCREDIA certificate: it is needed for standards and critical parameters. In a well-designed GMP system both coexist, with distinct, documented roles.

How do you choose a calibration laboratory for pharma?

Check four things: an accreditation scope consistent with the quantities and ranges to cover; experience in GMP environments (Annex 15, Annex 11, data integrity); the ability to work on site and to manage schedule, certificates and Out of Tolerance with an audit trail; response times compatible with production. A provider that only calibrates, without managing the system, leaves everything else to you.