Standard Operating Procedure for Deviation Handling in Creams Production
1) Purpose
The purpose of this SOP is to establish a systematic approach for identifying, documenting, investigating, and resolving deviations in creams production to ensure product quality, safety, and regulatory compliance.
2) Scope
This SOP applies to all personnel involved in creams production, including manufacturing, quality control, and quality assurance. It covers all deviations from established procedures, specifications, and regulatory requirements.
3) Responsibilities
The Quality Assurance (QA) Manager is responsible for overseeing the deviation handling process. All personnel are responsible for reporting deviations immediately and cooperating with investigations and corrective actions.
4) Procedure
4.1 Identification and Reporting of Deviations
4.1.1 Identify any deviation from established procedures, specifications, or regulatory requirements during creams production.
4.1.2 Report the deviation immediately to the supervisor or QA department.
4.1.3 Document the deviation using the Deviation Report Form, including the following information:
- Date and time of the deviation
- Description of the deviation
- Location of the deviation
- Personnel involved
- Immediate actions taken
4.2 Deviation Classification
4.2.1 Classify the deviation based on its potential impact on product quality, safety, and regulatory compliance:
- Minor Deviation: No significant impact on product quality or safety, and no regulatory impact.
- Major Deviation: Potential impact on product quality or safety, but no significant regulatory impact.
- Critical Deviation: Significant
4.3 Investigation of Deviations
4.3.1 Assign a deviation investigation team led by QA to investigate the root cause of the deviation.
4.3.2 Collect and review all relevant data, including batch records, equipment logs, and personnel statements.
4.3.3 Use root cause analysis tools, such as the 5 Whys or Fishbone Diagram, to determine the underlying cause of the deviation.
4.3.4 Document the findings of the investigation in the Deviation Report.
4.4 Corrective and Preventive Actions (CAPA)
4.4.1 Develop corrective actions to address the immediate cause of the deviation.
4.4.2 Develop preventive actions to eliminate the root cause and prevent recurrence of the deviation.
4.4.3 Assign responsibilities and timelines for implementing CAPA.
4.4.4 Document all CAPA activities in the Deviation Report.
4.5 Deviation Review and Approval
4.5.1 Review the completed Deviation Report and CAPA plan with the QA Manager and other relevant departments.
4.5.2 Obtain approval for the Deviation Report and CAPA plan from QA and other relevant stakeholders.
4.6 Implementation and Follow-Up
4.6.1 Implement the approved corrective and preventive actions according to the assigned timelines.
4.6.2 Monitor the effectiveness of CAPA to ensure that the deviation does not recur.
4.6.3 Conduct follow-up reviews to confirm the successful implementation of CAPA.
4.7 Documentation and Records
4.7.1 Maintain all records related to deviation handling, including Deviation Reports, investigation findings, and CAPA documentation.
4.7.2 Ensure that all deviation records are retained according to the company’s document retention policy.
5) Abbreviations, if any
QA: Quality Assurance
CAPA: Corrective and Preventive Actions
SOP: Standard Operating Procedure
6) Documents, if any
Deviation Report Form
Root Cause Analysis Tools (e.g., 5 Whys, Fishbone Diagram)
CAPA Records
7) Reference, if any
ICH Q10: Pharmaceutical Quality System
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
8) SOP Version
Version 1.0
