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