Standard Operating Procedure for Corrective and Preventive Actions (CAPA) in Gels Production
1) Purpose
The purpose of this SOP is to establish procedures for identifying, documenting, investigating, implementing, and verifying corrective and preventive actions (CAPA) in response to deviations, non-conformances, complaints, or other quality issues encountered during gels production.
2) Scope
This SOP applies to all personnel involved in the pharmaceutical manufacturing facility’s gels production department, including Quality Assurance (QA), Quality Control (QC), Production, and Engineering personnel responsible for CAPA management.
3) Responsibilities
Quality Assurance (QA) Team: Oversee the CAPA process and ensure compliance with SOPs.
Quality Control (QC) Analysts: Perform initial investigations and propose CAPAs based on data analysis.
Production Supervisors: Support CAPA implementation and monitor effectiveness in production processes.
Engineering Team: Provide technical support for CAPA implementation related to equipment or facility issues.
4) Procedure
4.1 CAPA Initiation
4.1.1 Identify and document deviations, non-conformances, customer complaints, or other quality issues that require CAPA based on predefined criteria.
4.1.2 Classify the issue based on severity, impact on product quality, and potential regulatory implications.
4.2 Investigation and Root Cause Analysis (RCA)
4.2.1 Initiate a thorough investigation to determine the root cause(s) of the issue using systematic RCA techniques (e.g., Fishbone diagram, 5 Whys).
4.2.2 Gather relevant data, perform analysis, and verify root causes to ensure comprehensive understanding.
4.3 CAPA Development
4.3.1 Develop and propose appropriate corrective actions to address identified root causes and prevent recurrence of the issue.
4.3.2 Identify and propose preventive actions to mitigate potential future occurrences of similar issues.
4.4 CAPA Review and Approval
4.4.1 Review and assess the proposed CAPA including corrective and preventive actions, feasibility, and expected outcomes.
4.4.2 Obtain approval from designated personnel, such as QA Manager or Production Manager, for implementation of CAPAs.
4.5 Implementation of CAPA
4.5.1 Implement approved CAPAs promptly and effectively, ensuring clear assignment of responsibilities and timelines.
4.5.2 Communicate CAPA implementation details to relevant departments and personnel involved.
4.6 Effectiveness Monitoring and Verification
4.6.1 Monitor the effectiveness of implemented CAPAs through follow-up activities, data analysis, and verification measures.
4.6.2 Document and report CAPA effectiveness findings, ensuring continuous improvement and compliance with regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
CAPA: Corrective and Preventive Actions
QA: Quality Assurance
QC: Quality Control
RCA: Root Cause Analysis
6) Documents, if any
– CAPA Report Form
– Root Cause Analysis Reports
– Corrective and Preventive Action Plans and Reports
7) Reference, if any
– FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations
– ISO 13485:2016 Medical devices – Quality management systems
– Company-specific CAPA procedures and guidelines
8) SOP Version
Version 1.0
