In SOP governance, who is typically accountable for ensuring the SOP reflects current regulatory requirements and is approved before issue?

• A. The process owner/SOP owner in collaboration with QA/compliance and the approving authority.
• B. The approving authority alone.
• C. QA/compliance only.
• D. The external auditor.

Answer: (B)

The approving authority is the role that holds final sign-off and release responsibility for an SOP. This person or role has the formal authority to authorize issuance, ensuring the document reflects current regulatory requirements before it goes out. They rely on inputs from the process owner to ensure the content is accurate and from QA/compliance to verify regulatory alignment, but the actual approval and issuing decision rests with the approver. This clear, singular point of accountability helps maintain a controlled, auditable process and avoids distribution of SOPs before all regulatory and quality checks are complete. An external auditor, while important for independent assessment, isn’t the entity that signs off and issues internal SOPs.