Regulatory References for the Operation, Maintenance and Calibration of GLP equipment

[AnaMariaVR2]

Dear Colleagues:

I want to see if anybody could guide me as to where can I find the regulatory references backing the operation, maintenance and calibration of several GLP equipment used in regulatory studies. Currently there is a lot of confusion about which standards apply and/or should be used for regulatory studies.

Which are the standards (FDA, ICH, ISO, etc., ?) to follow or that apply for the operation, maintenance and calibration of pipettes, pH meters, weight balances, plate readers, etc., or other more complex instrumentation?

I'm looking forward to your feedback. I want to clear the confusion at work, focus on the right standards and comply with them.

I appreciate everybody's time and consideration to my question.

Best Regards,
Ana Maria Rodriguez-Rojas

[AnaMariaVR2]

I just found the Pipette Standards Handbook and I want to share it with all.

[BradM]

Hi there!

NOTE: A alot of acronyms used here. If you are not familar with one of them, please ask.

I am not sure I understand your question. Within the framework of FDA, there are lots of standards like you mention, including CFR (Code of Federal Regulation for applicable items) and ISO (for applicable items).

For example, CFR addresses balances used to measure assay (Good Laboratory Practice work). But the Handbook 44 may be a better standard for non-GLP balances.

You posted a document on pipettes. I might go with IS0 8655 for that.

Cleanroom classifications are another, sterilization another, etc.

So yes, for many of the operation areas, there will be a standard. For some, there may not be one. A pressure gauge used for steam sterilization pressure will need to be calibrated, but may not have an associated standard. One would need to be developed for it.

[AnaMariaVR2]

Thanks BradM for your response!

Like you say, there will be clear standards for many of the operation areas, however for other areas/topics, there may not be clear one.

Despite all the guidances and regulations, there are problem (grey) areas in GLP bioanalysis which can cause uncertainty, inconsistency, regulatory citations and/or re-work.

How I see this, it seems to me that it may be due to one or a combination of these:

1. technical areas are not covered in great detail in the guidances or regulations.
2. 'translation' and application of the GLP regulations within the bioanalytical environment.
3. Regulatory citations for deficiencies in areas not clearly defined in guidances or regulations.

In my original posting I was mainly asking about which standards (FDA, ICH, ISO, etc., ?) to referenced in an SOP (for example) in order to establish quality/compliant procedures for the operation, maintenance and calibration of pipettes, pH meters, weight balances, plate readers, etc., or other more complex instrumentation. These types of activities are not covered in great detail in guidances or regulations. More clarity will be nice.