Standard Operating Procedure for Handling of Deviations

1) Purpose

The purpose of this SOP is to establish procedures for handling and investigating deviations from established processes, procedures, and specifications to ensure product quality and compliance.

2) Scope

This SOP applies to all deviations identified within the manufacturing facility that may impact product quality, safety, or efficacy.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Production Supervisor:

Responsible for documenting and reporting deviations to the Quality Assurance (QA) department.

3.2 Quality Assurance (QA) Personnel:

Responsible for investigating deviations, determining root causes, and implementing corrective actions.

3.3 Department Managers:

Responsible for implementing corrective actions and preventing recurrence of deviations within their departments.

4) Procedure

4.1 Identification and Documentation of Deviations:

4.1.1 Identify and document deviations from established processes, procedures, or specifications.
4.1.2 Record deviations in the Deviation Report Form.
4.1.3 Notify QA and relevant personnel of identified deviations.

4.2 Investigation of Deviations:

4.2.1 QA personnel must initiate an investigation into the deviation.
4.2.2 Gather information, conduct interviews, and review documentation to determine the root cause.
4.2.3 Document investigation findings and proposed corrective actions.

4.3 Evaluation and Risk Assessment:

4.3.1 Assess the impact of the deviation on product quality, safety, and efficacy.
4.3.2 Determine the risk associated with the deviation using risk assessment tools.
4.3.3 Classify the deviation based on severity and potential impact.

4.4 Implementation of Corrective Actions:

4.4.1 Develop and implement corrective actions to address the root cause of the deviation.
4.4.2 Implement preventive actions to prevent recurrence of similar deviations.
4.4.3 Obtain approval for corrective and preventive actions from QA.

4.5 Documentation and Review:

4.5.1 Document all steps of the deviation handling process, including identification, investigation, risk assessment, and corrective actions.
4.5.2 Review deviation records regularly to ensure compliance with procedures and effectiveness of corrective actions.
4.5.3 Archive deviation records according to established document retention policies.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Deviation Report Form
2. Investigation Findings
3. Corrective and Preventive Action (CAPA) Plans
4. Deviation Log

7) Reference, if any

1. FDA Guidance on Investigating Out-of-Specification (OOS) Results
2. ICH Q10 Pharmaceutical Quality System

8) SOP Version

Version 1.0