Standard Operating Procedure for Corrective and Preventive Actions (CAPA) in Aerosol 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 issues encountered during aerosol production. CAPA aims to prevent recurrence and improve processes.

2) Scope

This SOP applies to all CAPA activities conducted for deviations, non-conformances, complaints, or other quality issues related to aerosol production processes at [Company Name].

3) Responsibilities

Quality Assurance (QA) Manager: Oversee CAPA procedures and ensure compliance with SOPs.
Production Supervisor: Initiate CAPA requests and provide necessary documentation and information.
Operators: Report incidents promptly and assist in gathering data for CAPA investigations.
Quality Control (QC): Verify effectiveness of CAPA actions and provide input during investigation.

4) Procedure

4.1 CAPA Initiation:
4.1.1 Identify and document the deviation, non-conformance, or complaint that requires CAPA.
4.1.2 Classify the severity and potential impact on product quality and compliance.

4.2 Investigation:
4.2.1 Form an investigation team comprising representatives from QA, production, QC, and other relevant departments.
4.2.2 Conduct a thorough investigation to determine root causes and contributing factors using appropriate tools and techniques.

4.3 CAPA Plan Development:
4.3.1 Develop a CAPA plan based on investigation findings to address identified root causes and prevent recurrence.
4.3.2 Include clear objectives, actions, responsibilities, timelines, and measurable criteria for CAPA effectiveness.

4.4 Implementation:
4.4.1 Implement CAPA actions according to the approved plan.
4.4.2 Communicate CAPA actions to relevant personnel and ensure understanding and compliance.
4.4.3 Monitor and track progress of CAPA implementation.

4.5 Effectiveness Verification:
4.5.1 Verify the effectiveness of implemented CAPA actions through additional testing, monitoring, or validation.
4.5.2 Document verification activities and results to demonstrate CAPA effectiveness.
4.5.3 Close CAPA once objectives are achieved and compliance is confirmed.

4.6 Documentation:
4.6.1 Maintain detailed records of CAPA requests, investigations, plans, actions, and effectiveness verification.
4.6.2 Archive CAPA documentation in a controlled documentation system for traceability and regulatory inspections.
4.6.3 Review and update SOPs based on insights gained from CAPA outcomes and improvements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
CAPA: Corrective and Preventive Actions
QA: Quality Assurance
QC: Quality Control

6) Documents, if any

CAPA Request Form
Investigation Report
CAPA Plan and Implementation Records
CAPA Effectiveness Verification Report

7) Reference, if any

ICH Q10: Pharmaceutical Quality System
ISO 13485: Medical devices – Quality management systems
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

8) SOP Version

Version 1.0