Standard Operating Procedure for Handling Deviations

1) Purpose

The purpose of this SOP is to establish procedures for the identification, documentation, investigation, and resolution of deviations from established processes or procedures to ensure product quality, compliance, and continuous improvement.

2) Scope

This SOP applies to all departments and processes within the manufacturing facility that may be subject to deviations impacting product quality, safety, or efficacy.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Deviation Coordinator:

Responsible for managing and overseeing the deviation handling process.

3.2 Quality Assurance (QA) Specialist:

Responsible for reviewing and approving deviation investigations and corrective actions.

3.3 Department Managers/Supervisors:

Responsible for initiating deviation reports and implementing corrective actions.

4) Procedure

4.1 Deviation Identification:

4.1.1 Identify and document deviations from established processes or procedures.
4.1.2 Classify deviations based on impact on product quality, safety, or regulatory compliance.
4.1.3 Assign a unique deviation number and enter details into the Deviation Log.

4.2 Deviation Investigation:

4.2.1 Form an investigation team including relevant stakeholders (e.g., QA, Production).
4.2.2 Conduct a thorough investigation to determine root cause(s) of the deviation.
4.2.3 Document investigation findings and conclusions.

4.3 Impact Assessment:

4.3.1 Evaluate the impact of the deviation on product quality and safety.
4.3.2 Determine the need for immediate corrective actions to prevent further deviation occurrence.
4.3.3 Notify QA and Production management of the deviation assessment.

4.4 Corrective and Preventive Actions (CAPA):

4.4.1 Develop and implement corrective actions to address root causes of the deviation.
4.4.2 Propose preventive actions to prevent recurrence of similar deviations.
4.4.3 Obtain QA approval of CAPA plans and monitor implementation timelines.

4.5 Deviation Closure and Documentation:

4.5.1 Verify completion and effectiveness of implemented corrective actions.
4.5.2 Close deviation report and document final disposition and approval.
4.5.3 Archive deviation records and maintain for regulatory inspections and audits.

5) Abbreviations, if any

QA – Quality Assurance
CAPA – Corrective and Preventive Actions

6) Documents, if any

1. Deviation Log
2. Investigation Reports
3. CAPA Plans
4. Deviation Closure Records

7) Reference, if any

1. FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
2. ICH Q10 Pharmaceutical Quality System

8) SOP Version

Version 1.0