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Designing Fit-for-Purpose GCP SOPs: Inspection Readiness

To cap our series on fit-for-purpose GCP SOPs, we will look ahead to how SOPs are used in audits and inspections.

As we’ve established, GCPs don’t specify many requirements for quality control steps, but the thirteenth GCP principle states, “Systems with procedures that assure the quality of every aspect of the trial should be implemented.”  In other words, if it’s not required by GCP, but you need to do it to assure quality, then it should be part of your quality management system. Thus, auditors and inspectors look to SOPs to see what your quality management system requires, and they expect to review documentation that demonstrates that these steps were completed.

When preparing for inspection, teams should conduct a gap assessment against their internal SOPs to identify any steps that were not followed or where the scope of the SOP is not clear, then develop storyboards to use during practice interviews so they can explain these situations to an inspector. For example, we frequently encounter the following situations:

  • A sponsor’s SOP includes both execution and oversight steps for an activity, implying that it is always followed for that activity, but the task was outsourced to a vendor, so some of the steps in the SOP were followed, but others weren’t.  For example, a Financial Disclosure SOP covers initial collection of forms, regular updates, one-year follow-up, and oversight.  The CRO’s SOP is followed for initial collection and follow-ups, and the sponsor follows its SOP for one-year follow-up and oversight.
  • A small biotech starts its quality management system with a set of GMP-focused SOPs that are scoped to include all “GXP” activities.  When clinical studies start, the clinical team develops its own GCP-oriented SOPs for vendor selection and qualification and management of quality issues, but technically the original “GXP” SOPs also apply.
  • GCP SOPs are written with details that are intended to guide team members – for example, steps for in-person review meetings, or standard forms to capture key information – that turn out not to be practical for a particular study, and thus are not followed.

An alert auditor or inspector will review study output against SOPs that were in effect at the time the activity occurred. However, if your SOPs don’t align with your current practice, it is better to recognize the disconnect and modify the SOPs than to recognize the disconnect and leave the SOPs as they are.  When teams identify SOP non-compliance through their initial gap assessment, we always recommend that they revise their SOPs, even if it’s too late to affect that task for the study.  An inspector may generate a finding that you didn’t comply with the SOPs that were in effect at the time, but that’s better than two findings – that you were non-compliant AND failed to address the inconsistencies in your SOPs.

Auditees frequently tell us, “Well, yes, the SOP says X, but everyone knows that it means Y (or doesn’t really mean X, or means that X is optional).” An audit or inspection quickly highlights whether the words on the page convey the same meaning to readers outside the team as to readers inside the team. We hold the radical view that SOPs should say what they mean.

“Then you should say what you mean,” the March Hare went on. “I do,” Alice hastily replied; “at least — at least I mean what I say — that’s the same thing, you know.” “Not the same thing a bit!” said the Hatter. “You might just as well say that “I see what I eat” is the same thing as “I eat what I see”!”

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