Standard Operating Procedure for Out of Specification (OOS) Handling in Aerosol Production
1) Purpose
The purpose of this SOP is to establish procedures for identifying, investigating, and documenting out of specification (OOS) results encountered during aerosol production. Effective OOS handling ensures product quality, compliance with specifications, and regulatory requirements.
2) Scope
This SOP applies to all instances of OOS results identified during aerosol production processes at [Company Name].
3) Responsibilities
Quality Assurance (QA) Manager: Oversee OOS handling procedures and ensure compliance with SOPs.
Production Supervisor: Notify QA of OOS results and assist in investigation and corrective actions.
Operators: Report OOS results promptly and assist in providing accurate information for investigation.
Quality Control (QC): Verify the impact of OOS results on product quality and compliance.
4) Procedure
4.1 OOS Identification:
4.1.1 Operators or QC personnel identify and document OOS results during testing or production.
4.1.2 Record initial observations, including date, time, location, and description of the OOS result.
4.2 Notification:
4.2.1 Immediately notify QA and relevant personnel upon discovery of an OOS result.
4.2.2 Use designated forms or electronic systems to document and communicate OOS details.
4.3 Initial Assessment:
4.3.1 QA conducts a preliminary assessment to verify the OOS result and review testing procedures.
4.3.2 Classify OOS results based on significance and potential impact on product quality.
4.4 Investigation:
4.4.1 Establish an investigation team, including representatives from QA, production, and QC.
4.4.2 Conduct a thorough root cause analysis to identify factors contributing to the OOS result.
4.4.3 Document investigation findings, including potential causes and corrective actions.
4.5 Corrective and Preventive Actions (CAPA):
4.5.1 Develop and implement appropriate corrective actions to address identified root causes of the OOS result.
4.5.2 Verify effectiveness of corrective actions through additional testing or verification.
4.5.3 Implement preventive actions to prevent recurrence of similar OOS results.
4.6 Documentation:
4.6.1 Maintain detailed records of all OOS reports, investigations, and CAPA activities.
4.6.2 Archive documentation in a controlled manner for traceability and regulatory inspections.
4.6.3 Review and update SOPs based on findings from OOS investigations and CAPA implementation.
5) Abbreviations, if any
SOP: Standard Operating Procedure
OOS: Out of Specification
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions
6) Documents, if any
OOS Report Form
Investigation Report
CAPA Plan and Verification Records
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
ISO 17025: General requirements for the competence of testing and calibration laboratories
8) SOP Version
Version 1.0
