Bioequivalence and Bioavailability Forum

Hello Ken,

❝ How frequent should we review SOP (in GCP or GLP settings) ?

No rule is given.

❝ Do we have to provide explanation or justification for reviewing SOP ?

No rule is given. But I would say -this is my personal subjective opinion- that you should justify if you do not review SOPs with regular intervals.

❝ Do we need to prepare SOP for each and every activity ?

If the activity is essential to the activity you are doing then yes. For example GCP ICH E6 clause 2.13: Systems with procedures that assure the quality of every aspect of the trial should be implemented.


I have a vague feeling that you may be under fire from another side here: ISO/IEC 17025?? If this is the case and if you have the certificate then you might have had a visit from an inspector/auditor who you also need to satisfy. ISO works extensively with management reviews and blah blah, and the inspector/auditor could have dictated a meeting frequency based on the perceived maturity of your QMS.
A typical question auditors/inspectors may ask is something like "What do you do if you feel an SOP needs revision?" - this could be asked to any employee, and there should be some degree of consistency between the answers. If some of the ordinary (non-management) employees reply "I tell my boss", others say "I inform the QA manager" and some say "I tell the upper management" then you could be noted for a deficiency unless there is an SOP that specifies exactly that for the different employees/functions.

QA spreads like rings in the water.

Dear Ken,

❝ Do we need to prepare SOP for each and every activity ?

A list of suggested SOPs is provided in WHO's guidance for organisations performing BE studies.

Regards
Ohlbe