GMP Critical vs Non-Critical Requirements

GOOD MANUFACTURING PRACTICE (cGMP)
1

Hello,

Regarding the need to have GMP critical devices calibrated more
frequently than GMP non-critical devices that cannot directly impact
product quality, the quality manual “Good Manufacturing Practices
For Pharmaceuticals” by Josheph D. Nally states: “…one scheme
would be to set the default calibration frequencies to quarterly for
GMP critical, semi-annually for GMP non-critical, and annually for
for GMP utility (general use) devices. […] though there
should be upper limits, that is, no less frequently than semi-annually
for GMP critical devices, no less frequently than annually for GMP
non-critical, and no less frequently than bi-annually for GMP utility
devices.”

Although of course factors such as: use, mfg specs, track record and
the like must also be factored in, what I would like to know is if such
a scheme aligns with industry practice? Is anyone following a different
scheme that they would care to share?

Any comments would be appreciated.

1 Like
2

At my site, we do not do schedule-based calibrations on non-critical instruments. The calibration department will do a calibration upon request, but they are not performed based on a defined schedule. Our view is that non-critical instruments are for maintenance and troubleshooting purposes, and are therefore not held to the same standard.

1 Like
3

Thanks for the response! It makes good sense to me. Is your site a GMP environment as well? How are instruments classified as critical or non-critical there? Do process owners or deparment engineering do that or is it more of team effort?

Thanks again.