SOP Basics
What does SOP stand for?
Standard Operating Procedure
SOPs help ensure consistency in what?
Process and Operations.
True or False: Employees can skip SOP steps for a good enough reason.
FALSE
True or False: SOPs should be written in clear, simple language.
True
During a process, you realize the SOP contains an error. What is your next step?
Stop the process and notify your supervisor or QA
SOPs are written instructions that describe what?
A specific process, task, or activity.
SOPs are critical for maintaining compliance with what?
Regulatory Requirements
How can non-compliance with SOPs impact a company’s reputation and market position?
Non-compliance can lead to loss of customer trust, damaged reputation, and reduced market share due to recalls or regulatory actions.
How are diagrams and flowcharts helpful in SOPs?
They can make the instructions easier to understand.
A coworker suggests a faster way to complete a task that deviates from the SOP. Should you follow their suggestion?
No, all deviations must be formally investigated and approved before continuing
Which two regulatory body requires the use of SOPs in a GMP environments?
FDA (Food & Drug Administration) and EU (European Union)
Name one risk of not following SOPs
Contamination, deviation, patient harm, regulatory violation.
What is the significance of including "roles and responsibilities" in an SOP?
It ensures accountability and clarity by defining who is responsible for each step of the procedure.
Who should review and approve an SOP before it is implemented?
Quality Assurance (QA) team, any department with responsibilities, Document Control*.
You are performing a cleaning procedure outlined in an SOP, but the cleaning agent specified is unavailable. What should you do?
Stop the procedure and consult QA or your supervisor for guidance.
True or Fales: Reference documents should also be read if referred in the guiding SOP.
True
How do SOPs align with the concept of "data integrity" in GMP environments?
SOPs ensure that data is accurate, complete, and consistent by standardizing how data is recorded, reviewed, and stored.
What should an employee do if they identify a step in an SOP that is unclear?
Report the issue to their supervisor or quality assurance team.
Why is it critical to involve subject matter experts (SMEs) in the SOP writing process?
SMEs provide technical knowledge and practical insights to ensure the SOP is accurate, comprehensive, and applicable.
During an audit, the inspector asks why a specific SOP was revised. How should you respond?
Reference the SOP's Revision History for process changes, regulatory updates, or error corrections.
What controls do we have for ensuring an effective version of an SOP is used?
DMS digital controls - linking to effective version.
Hard copies - effective watermark and header/footer info.
Training on new versions.
Version number and Revision histories.
What is the FDA's expectation regarding the frequency of SOP reviews and updates?
SOPs must be reviewed periodically (e.g., annually or biennially) or whenever there is a significant change in processes, regulations, or equipment.
What are two things you must verify before executing an SOP?
Effective Version and applicable training completed.
Why is it essential to involve cross-functional teams in the development of SOPs?
Cross-functional teams provide diverse perspectives, ensuring the SOP is accurate, practical, and applicable across departments
You are asked to audit compliance with an SOP. What key elements should you check during the audit?
Verify that all steps are followed, documentation is complete, and employees are properly trained.