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Designing Fit-for-Purpose GCP SOPs: Saving Ink
In this series of blog posts, we discussed how we can design GCP SOPs that meet the needs of the organization using them, including size, experience level, volume, specialization of roles, sourcing strategy, and complexity. We’ve looked at the cost of each individual document and made an argument for limiting the number of SOPs to reduce the burden on the organization.
In addition to limiting the number of SOPs, we should also strive to limit the length of each SOP. If each SOP represents hours of work, then each page of an SOP, it could be argued, also imposes a cost on the organization. If those pages promote efficiency, then the cost is worth it. We conduct many audits, though, where conflicting information in an SOP results in non-compliance, or users miss a key detail in an SOP because it’s buried in pages of non-critical material.
Following are three sections of GCP SOPs that could be shortened considerably:
Definitions. As a rule, define any term specific to your organization that could not be discerned in context. For example, the purpose and membership of a “Protocol Review Committee” is not standard across organizations; the definition of “critical, major, and minor” findings also differs. Avoid defining common terms like “protocol” or “site monitor,” or terms that are not common but are defined in GCP, such as “Case Report Form.” When in doubt, ask, “Is someone likely to perform this process incorrectly because they don’t understand the definition of the word ‘audit’?” If not, leave it out!
Responsibilities. Many SOPs feature a “Responsibilities” section that summarizes the process but groups the summary by responsible party rather than presenting the steps chronologically. During the drafting or revision process, the Responsibilities and Procedure sections can become unaligned, resulting in a step that is included in one section but not another, or steps that are worded conflictingly in the two sections. Users can’t comply with two opposite requirements, so non-compliance ensues. Originally, this section appears to have been intended to provide a shorthand reference to the parties that need to train on an SOP. We recommend leaving this section out or replacing it with a list of applicable roles.
References. It makes sense to include references to laws, regulations, and standards that govern an SOP, especially when we’re advocating SOPs that are lean on detail. The problem is, where do you stop? If we include US regulations, do we include other regions as well? If we include GCP, what about other ICH guidances? Other regional guidances? How about reflection papers and EMA Q&As? As a rule of thumb, we recommend only including references that are referenced in the text of the SOP. In other words, if your SOP is about how to comply with US financial disclosure requirements, then both the text and the reference section might include a reference to 21 CFR Part 54. But an SOP about site monitoring would not need to reference every applicable CFR section unless referenced in the text.
Computer System Guidance: Digital Health Technologies