Standard Operating Procedure for Managing Deviations

1) Purpose

The purpose of this SOP is to establish a procedure for the identification, documentation, investigation, and resolution of deviations from established procedures and specifications.

2) Scope

This SOP applies to all personnel involved in the manufacturing, testing, and quality control of pharmaceutical products within the facility.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 All Personnel:

Responsible for identifying and reporting deviations.

3.2 Quality Assurance (QA) Personnel:

Responsible for investigating deviations, determining root causes, and implementing corrective and preventive actions (CAPA).

3.3 Department Managers:

Responsible for ensuring deviations are managed in accordance with this SOP.

4) Procedure

4.1 Identification and Reporting of Deviations:

4.1.1 Identify deviations from established procedures and specifications.
4.1.2 Report deviations immediately to the QA department.
4.1.3 Document deviations using the Deviation Report Form.

4.2 Investigation of Deviations:

4.2.1 QA personnel must investigate reported deviations to determine root causes.
4.2.2 Interview relevant personnel and review documentation and records.
4.2.3 Document the findings of the investigation, including the identified root cause.

4.3 Implementation of Corrective and Preventive Actions (CAPA):

4.3.1 Develop CAPA plans to address the root causes of deviations.
4.3.2 Implement CAPA plans promptly to prevent recurrence of deviations.
4.3.3 Monitor the effectiveness of CAPA plans and make adjustments as necessary.

4.4 Documentation and Review:

4.4.1 Document all steps of the deviation management process, including identification, investigation, and CAPA implementation.
4.4.2 Review deviation records regularly to identify trends and areas for improvement.
4.4.3 Ensure all deviation records are complete, accurate, and stored securely.

5) Abbreviations, if any

QA – Quality Assurance
CAPA – Corrective and Preventive Actions

6) Documents, if any

1. Deviation Report Forms
2. Investigation Records
3. CAPA Plans
4. Deviation Logs

7) Reference, if any

1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ICH Q10 Pharmaceutical

Quality System

8) SOP Version

Version 1.0