Standard Operating Procedure for Deviation Handling in Gels Production
1) Purpose
The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of deviations that occur during gels production, ensuring product quality, process integrity, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the pharmaceutical manufacturing facility’s gels production department, including deviation initiators, investigators, reviewers, and approvers.
3) Responsibilities
Quality Assurance (QA) Team: Oversee deviation management process and ensure compliance with SOPs.
Production Supervisors: Initiate deviation reports and implement corrective actions as necessary.
Quality Control (QC) Analysts: Provide data and analysis to support deviation investigations.
4) Procedure
4.1 Deviation Identification
4.1.1 Identify and document deviations from approved procedures, specifications, or expected outcomes.
4.1.2 Classify deviations based on severity, impact on product quality, and regulatory implications.
4.2 Deviation Documentation
4.2.1 Complete a deviation report form detailing the deviation event, including date, time, location, and description of the deviation.
4.2.2 Attach relevant supporting documents such as batch records, laboratory results, and equipment logs.
4.3 Deviation Investigation
4.3.1 Initiate an investigation to determine the root cause(s) of the deviation using systematic root cause analysis techniques.
4.3.2 Identify corrective and preventive actions (CAPAs) to address the root cause(s) and prevent recurrence.
4.4 Review and Approval
4.4.1 Review and assess the investigation findings, CAPAs, and proposed corrective actions.
4.4.2 Obtain approval from designated personnel, such as QA Manager or Production Manager, for implementation of CAPAs.
4.5 Implementation of Corrective Actions
4.5.1 Implement approved corrective actions promptly and effectively to address identified deviations.
4.5.2 Monitor the effectiveness of implemented CAPAs through follow-up and verification activities.
4.6 Documentation and Reporting
4.6.1 Document all deviation handling activities, including investigation outcomes, CAPA implementation status, and follow-up actions.
4.6.2 Report significant or recurring deviations to management and regulatory authorities as required.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions
6) Documents, if any
– Deviation Report Form
– Root Cause Analysis Reports
– Corrective and Preventive Action (CAPA) Plans and Reports
7) Reference, if any
– FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
– EU GMP Chapter 1: Pharmaceutical Quality System
– Company-specific deviation handling procedures and guidelines
8) SOP Version
Version 1.0