Standard Operating Procedure for Corrective and Preventive Actions (CAPA) in Creams Production
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1) Purpose
The purpose of this SOP is to establish a systematic process for identifying, documenting, and implementing corrective and preventive actions (CAPA) in creams production to ensure continuous improvement and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the production, quality control, and quality assurance of creams. It covers all incidents, deviations, non-conformances, and customer complaints that require CAPA.
3) Responsibilities
The Quality Assurance (QA) Manager is responsible for overseeing the CAPA process. All personnel are responsible for reporting quality issues and participating in the CAPA process as required.
4) Procedure
4.1 Identification of Issues
4.1.1 Identify any quality issues, including deviations, non-conformances, audit findings, and customer complaints, that require CAPA.
4.1.2 Document the identified issue using the CAPA Request Form, including a description of the issue, date, and reported by.
4.2 Initial Assessment
4.2.1 QA Manager reviews the CAPA Request Form and conducts an initial assessment to determine the potential impact on product quality and compliance.
4.2.2 Assign a priority level to the CAPA based on the severity and potential impact of the issue.
4.3 Root Cause Analysis
4.3.1 Form an investigation
4.3.2 Conduct a root cause analysis using appropriate tools (e.g., 5 Whys, Fishbone Diagram) to identify the underlying cause(s) of the issue.
4.3.3 Document the findings of the root cause analysis in the CAPA Report.
4.4 Development of Corrective Actions
4.4.1 Develop corrective actions to address the immediate cause of the issue and prevent its recurrence.
4.4.2 Assign responsibilities and timelines for implementing the corrective actions.
4.4.3 Document the corrective actions in the CAPA Report.
4.5 Development of Preventive Actions
4.5.1 Develop preventive actions to address the root cause(s) of the issue and prevent similar issues from occurring in the future.
4.5.2 Assign responsibilities and timelines for implementing the preventive actions.
4.5.3 Document the preventive actions in the CAPA Report.
4.6 Implementation of CAPA
4.6.1 Implement the approved corrective and preventive actions according to the assigned timelines.
4.6.2 Ensure that all actions are documented and records are maintained.
4.7 Effectiveness Check
4.7.1 Conduct follow-up reviews to verify the effectiveness of the implemented CAPA.
4.7.2 Document the results of the effectiveness check in the CAPA Report.
4.7.3 If the CAPA is found to be ineffective, reinitiate the root cause analysis and develop additional actions as necessary.
4.8 Review and Approval
4.8.1 QA Manager reviews the completed CAPA Report, including all findings, actions, and effectiveness checks.
4.8.2 Obtain approval for the CAPA Report from QA and other relevant stakeholders.
4.9 Documentation and Records
4.9.1 Maintain all records related to the CAPA process, including CAPA Request Forms, CAPA Reports, and effectiveness check documentation.
4.9.2 Ensure that all CAPA records are retained according to the company’s document retention policy.
5) Abbreviations, if any
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions
SOP: Standard Operating Procedure
6) Documents, if any
CAPA Request Form
CAPA Report
Root Cause Analysis Tools (e.g., 5 Whys, Fishbone Diagram)
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