With any calibration measurement, having confidence in the
results and performance of the measurement instruments is critically important.
The lab conducting the calibration must instill the level of confidence for the
end user to ensure trust in the measurement device. The pharmaceutical industry
is even more concerned about the quality of calibration, as inaccurate
measurements can result in serious breaches
of process, product
recall, or potential fines from the U.S. Food and Drug Administration (FDA).
Providing a higher level of confidence to the user can be
established by using laboratories that are accredited to ISO/IEC 17025.
Laboratories attaining accreditation have been assessed by an auditor(s) that
has specific skill sets to verify the technical competence of the laboratory.
Benefits to Using an
Accredited Lab
There are number of accreditation bodies in the U.S., including
the American Association for Lab Accreditation
(A2LA), the National
Voluntary Laboratory Accreditation Program (NAVLAP) and the Laboratory Accreditation Bureau (L-A-B). There
are substantial benefits behind an accredited laboratory. They have proven they
are technologically competent to carry out the calibration within the laboratory’s
scope of accreditation. Confidence in these laboratories is thus significantly
higher than those laboratories that do not have accreditation.
In order for
accreditation bodies to recognize each others' accreditations, the International Laboratory Accreditation Cooperation
worked to establish methods of evaluating accreditation bodies against another
ISO conformity (ISO/IEC
17011). Accreditation is a process in which certification of
competency, authority, or credibility is presented.
Accreditation enforces all the requirements of ISO/IEC 17025
are met. Requirements ranging from proficiency testing, traceability to an international
standard and established uncertainties for all measurement parameters to a
fully documented quality and management system are assessed annually.
Confidence in an accredited calibration laboratory far outweighs other
laboratories that have not attained accreditation.
Auditing Requirements
The FDA requires pharmaceutical companies to audit
their suppliers on a regular basis. This is both costly to the companies as
well as the laboratory being audited. Time from a laboratory’s schedule must be
allotted to the auditing team in order to cover the lab’s management system,
quality system, reference standards, training records, procedures, and
policies. Accreditation provides third party assessment of a laboratory and
thus ensures higher level of faith in any measurement device they have
calibrated.
ISO/IEC 17025 accreditation requires bi-annual assessments
covering the entire checklist of the standard. This assessment is completed by
experts in the field. In the interim year, the laboratory must submit an internal
assessment to the full check list of ISO/IEC 17025 along with Proficiency Testing
or Inter-Laboratory comparison, Internal Audit results, and Management Review of
meeting minutes.
Make sure when you are selecting a lab for calibrating your
equipment that they are accredited and meeting the requirements for ISO.
Beginning with St.
Louis on Thursday, May 5, and monthly thereafter,
Vaisala will offer free cGMP seminars in
select cities for life science industry professionals who are involved with
regulatory compliance or monitoring and measurement in controlled environments.
Vaisala will also be offering free webinars
starting in April 2011. For more information, send an email tobruce.mcduffee@vaisala.com