Standard Operating Procedure for Deviation and Corrective Action

Purpose

The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of deviations from established processes or procedures within the pharmaceutical manufacturing facility. Additionally, it outlines the steps for implementing corrective actions to prevent recurrence.

Scope

This SOP applies to all personnel involved in the manufacturing, quality control, and quality assurance of pharmaceutical products, including operators, technicians, and quality assurance personnel.

Responsibilities

• All Personnel: Responsible for immediately reporting any observed or potential deviations from standard processes or procedures.
• Operators and Technicians: Responsible for documenting and reporting deviations during their respective activities.
• Quality Assurance Personnel: Responsible for overseeing the deviation investigation and ensuring the implementation of corrective actions.

Procedure

1. Deviation Identification: Immediately report any observed or potential deviations from standard processes or procedures to the appropriate supervisor or quality personnel.
2. Deviation Documentation: Document all relevant details of the observed deviation, including the date, time, location, personnel involved, and a brief description of the deviation.
3. Deviation Classification: Classify deviations based on their severity and potential impact on product quality, patient safety, and regulatory compliance.
4. Deviation Investigation: Initiate a thorough investigation to identify the root cause of the deviation. Involve relevant personnel, including operators, technicians, and quality assurance personnel.
5. Investigation Report: Prepare a detailed deviation investigation report, including findings, root cause analysis, and proposed corrective actions.
6. Corrective Action Plan: Develop a corrective action plan to address the root cause and prevent the recurrence of the deviation. Include specific actions, responsibilities, and timelines.
7. Implementation of Corrective Actions: Execute the corrective action plan in a timely manner. Ensure that all personnel involved are aware of and trained on the corrective actions.
8. Effectiveness Check: Conduct an effectiveness check to verify that the corrective actions have been implemented successfully and are preventing recurrence.
9. Documentation of Corrective Actions: Document all corrective actions taken, including updates to procedures, training records, and any changes made to prevent similar deviations in the future.
10. Approval: Obtain necessary approvals for the deviation investigation report and the effectiveness check before closing the deviation.
11. Communication: Communicate the resolution of the deviation to relevant personnel and stakeholders as necessary.
12. Review and Trend Analysis: Periodically review deviation records and perform trend analysis to identify recurring issues and implement proactive measures.
13. Archiving: Archive deviation records in accordance with established retention policies.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Deviation Logbook
• Deviation Investigation Report
• Corrective Action Plan
• Effectiveness Check Records

Reference

ICH Q9 – Quality Risk Management

SOP Version

Version 1.0