1. Purpose of Investigation of Sterility Test Failure
The purpose of this Standard Operating Procedure (SOP) for Investigation of Sterility Test Failure is to establish a systematic process for investigating and addressing sterility test failures within [Company Name]. This SOP for Investigation of Sterility Test Failure aims to ensure the accurate identification of the root cause of the failure and the implementation of corrective actions to prevent recurrence.
2. Scope of Investigation of Sterility Test Failure
This SOP for Investigation of Sterility Test Failure applies to all personnel responsible for conducting sterility tests and investigating test failures within [Company Name]. It encompasses the procedures for initiating, conducting, and documenting the investigation process.
3. Definitions involved in Investigation of Sterility Test Failure
3.1 Sterility Test:
A microbiological test conducted to determine the absence or presence of viable microorganisms in a sample.
3.2 Sterility Test Failure:
The outcome of a sterility test that indicates the presence of viable microorganisms in a sample, contrary to the expected sterile condition.
3.3 Root Cause Analysis:
The process of identifying the fundamental reason(s) behind an issue or failure.
4. Safety Precautions and Personal Protective Equipment (PPE)
4.1. PPE Requirements
4.1.1 Personnel involved in the investigation shall wear appropriate PPE, including lab coats, gloves, and masks.
4.1.2 PPE shall be properly inspected for any damage or wear before use.
4.2. Clean Work Practices
4.21 Maintain a clean and organized work area to prevent cross-contamination during the investigation.
4.2.2 Follow aseptic techniques to prevent introduction of contaminants.
5. Initial Response and Isolation
5.1. Identification and Documentation
5.1.1 Identify and document the sterility test failure as per established procedures.
5.1.2 Label the failed sample clearly for future reference.
5.2. Isolation
5.2.1 Quarantine the failed sample and any associated materials to prevent further spread of contamination.
5.2.2 Isolate any affected equipment or materials that might have contributed to the failure.
6. Root Cause Analysis
6.1. Investigation Team Formation
6.1.1 Form an investigation team composed of personnel from relevant departments, including microbiology, quality assurance, and production.
6.1.2 Designate a team leader responsible for coordinating the investigation.
6.2. Investigation Plan
6.2.1 Develop an investigation plan outlining the objectives, methodology, and responsibilities of each team member.
6.2.2 Specify the timeline for completing each phase of the investigation.
6.3. Data Collection
6.3.1 Gather relevant data, including sterility test records, batch records, environmental monitoring data, and any deviations.
6.3.2 Ensure accurate and comprehensive documentation of all findings.
6.4. Root Cause Identification
6.4.1 Utilize tools such as the “5 Whys” and fishbone diagrams to identify potential root causes.
6.4.2 Investigate potential sources of contamination, procedural errors, and equipment malfunctions.
7. Corrective Actions and Preventive Measures
7.1. Corrective Actions
7.1.1 Develop and implement immediate corrective actions to address the identified root cause.
7.1.2 Ensure that corrective actions are based on the investigation findings and are effective in preventing recurrence.
7.2. Preventive Measures
7.2.1 Identify and implement preventive measures to prevent similar failures in the future.
7.2.2 Review and update procedures, training, and processes as necessary.
8. Reporting and Documentation
8.1. Investigation Report
8.1.1 Prepare a comprehensive investigation report detailing the failure, investigation findings, root cause, corrective actions, and preventive measures.
8.2.2 Ensure the report is accurate, complete, and signed by the appropriate personnel.
8.2. Regulatory Reporting
8.2.1 If required by regulatory authorities, promptly report sterility test failures as per regulatory guidelines.
8.2.2 Maintain records of regulatory notifications and correspondence.
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