Who must approve an SOP before release for use?

• A. The SOP owner and QA only
• B. SOP owner, QA/compliance, and department head
• C. SOP owner, QA/compliance, department head, and regulatory liaison as required
• D. SOP owner, safety officer, and IT

Answer: (C)

The main idea here is that approving an SOP before it goes into use requires input from the people who own the content, ensure quality and regulatory compliance, confirm it fits the department’s needs, and bring in regulatory expertise when the process is regulated. The SOP owner is the person responsible for the procedure’s accuracy and content. QA or compliance confirms that the procedure meets the organization’s quality standards and any applicable regulatory requirements. The department head ensures the procedure makes sense operationally, aligns with the team’s workflow, and has the necessary resources. The regulatory liaison is included when the SOP touches regulatory rules or standards, making sure all external requirements are addressed and that approvals align with those rules. Some SOPs don’t involve regulatory oversight, but when they do, involving the regulatory liaison as needed keeps the document compliant and release-ready. This combination—owner, QA/compliance, department head, and regulatory liaison as required—best ensures the SOP is accurate, practical, and compliant before use.