Calibration and qualification in analytical laboratories

Calibration and qualification in analytical laboratories is needed because laboratory equipment should demonstrate suitability for the intended use. The way to do this is by calibrating and qualifying them. Calibration and qualification in analytical laboratories are also necessary because they are subject to FDA inspections.

Laboratory equipment is high risk systems

Calibration and qualification in analytical laboratories are necessary also because laboratory equipment is high risk systems in that they impact product quality greatly. Because of this categorization, equipment calibration and qualification is a frequently cited deviation in FDA inspectional observations. They are also targets of warning letters. To avoid all these scenarios, calibration and qualification in analytical laboratories is called for, although it is possible that many times, companies are not sure on exactly which of their equipment they need to calibrate, qualify, test and document.

Important factors

Three important factors impact the reliability of analytical data generated from chemical and physical analyses critically:

  • How much validity the analytical methods used have;
  • The extent to which the instruments used for the experiments are reliable;
  • How well and how appropriately the analysts undertaking the calibration and training are trained

What does the FDA say?

The FDA’s c-GMP requirements (CFR – Code of Federal Regulations, Subpart I: Laboratory Controls, S211.160 (b) (4)) has this to say about the scope of calibration and qualification in analytical laboratories:

“The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used.”

References:

http://www.cvg.ca/images/Qualification.pdf

http://www.labcompliance.com/seminars/audio/226/default.aspx

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s