Handling Deviations in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for handling deviations during the formulation development process, ensuring that deviations are documented, investigated, and resolved promptly to maintain product quality and compliance with regulatory requirements.

2) Scope

This SOP applies to all formulation development projects within the organization, covering the handling of deviations related to processes, procedures, materials, and equipment.

3) Responsibilities

The responsibilities for this SOP include:
Formulation Development Team: Reporting deviations and assisting in investigations to determine root causes and corrective actions.
Quality Assurance: Reviewing and approving deviation reports, investigations, and corrective actions to ensure compliance with quality standards.
Quality Control: Conducting testing and assessments to support deviation investigations and resolution.
Regulatory Affairs: Assessing the impact of deviations on product quality and regulatory filings.

4) Procedure

4.1 Deviation Reporting

1. Identify and document deviations from approved procedures, specifications, or expected results promptly upon discovery.
2. Complete a deviation report form detailing the nature of the deviation, impact on product quality, and initial assessment of root cause.
3. Submit the deviation report for initial review and classification based on severity and potential impact.

4.2 Deviation Investigation

1. Initiate a thorough investigation to determine the root cause of the deviation, involving relevant subject matter experts and stakeholders.
2. Collect and analyze relevant data, including batch records, testing results, and environmental conditions, to identify contributing factors.
3. Document findings from the investigation, including a clear description of the deviation’s cause and potential preventive actions.

4.3 Corrective and Preventive Actions (CAPA)

1. Develop and implement corrective actions to address the root cause of the deviation and prevent recurrence.
2. Document and communicate corrective actions to relevant personnel and departments responsible for implementation.
3. Monitor the effectiveness of corrective actions through verification activities, including follow-up testing and assessments.

4.4 Review and Approval

1. Review deviation reports, investigation findings, and proposed corrective actions with cross-functional teams, including quality assurance, regulatory affairs, and management.
2. Obtain approval for proposed corrective actions and ensure all necessary documentation is updated to reflect changes.
3. Document final approval of deviation reports and associated corrective actions for audit and regulatory purposes.

4.5 Closure and Documentation

1. Close the deviation report upon successful implementation and verification of corrective actions.
2. Document all deviation handling activities, including reports, investigations, corrective actions, and verification results.
3. Archive deviation reports and associated documentation for future reference, audits, and regulatory inspections.

5) Abbreviations, if any

SOP: Standard Operating Procedure
CAPA: Corrective and Preventive Actions

6) Documents, if any

Deviation Report Form
Investigation Findings Report
CAPA Plan and Documentation
Verification and Follow-up Reports

7) Reference, if any

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

8) SOP Version

Version 1.0