Standard Operating Procedure for Handling Out of Specification (OOS) Results in Creams Production
1) Purpose
The purpose of this SOP is to establish a standardized process for handling Out of Specification (OOS) results in creams production, ensuring timely identification, investigation, and resolution of OOS results to maintain product quality and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the production and quality control of creams. It covers the handling of OOS results obtained during raw material testing, in-process testing, and final product testing.
3) Responsibilities
The Quality Assurance (QA) Manager is responsible for overseeing the OOS handling process. Quality Control (QC) personnel are responsible for identifying and reporting OOS results. Production personnel are responsible for assisting in the investigation and implementation of corrective actions.
4) Procedure
4.1 Identification and Reporting of OOS Results
4.1.1 Identify any result that falls outside the established specification limits during testing.
4.1.2 Immediately notify the QA Manager and document the OOS result in the laboratory notebook or appropriate record.
4.1.3 Initiate an OOS Report, including the following information:
- Test performed
- Specification limits
- Obtained result
- Date and time of the test
- Analyst’s name
4.2 Preliminary Investigation
4.2.1 Conduct a preliminary investigation to determine if the OOS result is due
4.2.2 Review the analytical method, equipment calibration, reagent validity, and analyst’s technique.
4.2.3 If a laboratory error is identified, document the findings and perform a retest.
4.2.4 If no laboratory error is identified, proceed to a full-scale OOS investigation.
4.3 Full-Scale OOS Investigation
4.3.1 Form an investigation team including QA, QC, and Production representatives.
4.3.2 Review all relevant data, including batch records, raw material certificates, and in-process control results.
4.3.3 Perform additional testing if necessary to confirm the OOS result.
4.3.4 Use root cause analysis tools (e.g., 5 Whys, Fishbone Diagram) to identify the root cause of the OOS result.
4.3.5 Document all findings in the OOS Report.
4.4 Corrective and Preventive Actions (CAPA)
4.4.1 Develop corrective actions to address the root cause of the OOS result.
4.4.2 Develop preventive actions to prevent recurrence of the OOS result.
4.4.3 Assign responsibilities and timelines for implementing CAPA.
4.4.4 Document all CAPA activities in the OOS Report.
4.5 Review and Approval
4.5.1 Review the completed OOS Report and CAPA plan with the QA Manager and other relevant departments.
4.5.2 Obtain approval for the OOS 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 the OOS result 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 OOS handling, including OOS Reports, investigation findings, and CAPA documentation.
4.7.2 Ensure that all OOS records are retained according to the company’s document retention policy.
5) Abbreviations, if any
OOS: Out of Specification
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions
SOP: Standard Operating Procedure
6) Documents, if any
OOS Report Form
Root Cause Analysis Tools (e.g., 5 Whys, Fishbone Diagram)
CAPA 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
8) SOP Version
Version 1.0