Certified Pharmaceutical GMP Professional Practice

Which step is NOT part of the SOP creation process?

1. Issue the SOP

2. Follow the procedure as it was written

3. Leave gaps in the documentation

4. Revise and edit as necessary

The correct answer is: Leave gaps in the documentation

In the context of creating Standard Operating Procedures (SOPs), leaving gaps in the documentation is not a recommended practice and does not constitute a valid step in the SOP creation process. An effective SOP should be comprehensive and clearly outline all necessary steps, responsibilities, and processes to ensure consistency and compliance within the organization. An SOP serves to guide employees in executing tasks effectively and consistently, minimizing risks associated with misunderstandings or omissions. Therefore, creating a document that has gaps can lead to confusion, operational errors, and increases the likelihood of non-compliance with regulatory standards. It is essential that SOPs are thorough and all-encompassing to ensure that they serve their purpose of providing clear and actionable guidance. In contrast, issuing the SOP, following the procedure as it was written, and revising and editing as necessary are all integral parts of the SOP creation process. Issuing the SOP signifies that it is finally approved and ready for use, while following the procedure ensures that the intended actions are performed correctly. Additionally, revisiting and updating the SOP helps maintain its relevance and accuracy in response to changes in processes or regulations.