1. Purpose:
1.1 This SOP outlines the procedure for testing the bioburden of fractional solutions to ensure compliance with quality standards.
2. Scope:
2.1 This procedure applies to all fractional solutions used in the manufacturing process.
3. Responsibilities:
3.1 Quality Assurance (QA):
3.1.1 Oversee the implementation and adherence to this SOP.
3.1.2 Verify that testing personnel are appropriately trained and qualified.
3.1.3 Review and approve any deviations from the acceptance criteria.
3.2 Microbiology Department:
3.2.1 Conduct bioburden testing in accordance with established procedures.
3.2.2 Ensure the availability and proper functioning of equipment and materials required for testing.
3.2.3 Report any abnormalities or deviations to QA promptly.
3.3 Testing Personnel:
3.3.1 Wear appropriate personal protective equipment, including sterile gloves, during sample collection. 3.3.2 Aseptically collect and handle samples according to specified procedures.
3.3.3 Dilute samples accurately and transfer them to culture media following aseptic techniques.
3.3.4 Record all relevant information, including sample details and dilution factors.
3.3.5 Perform colony counting and document results accurately.
3.3.6 Report any issues or concerns encountered during the testing process to the Microbiology Department.
4. Materials and Equipment:
4.1 Sterile containers for sample collection
4.2 Sterile pipettes
4.3 Sterile diluent
4.4 Culture media
4.5 Incubator
4.6 Colony counter
4.7 Sterile gloves
5. Procedure:
5.1 Sample Collection:
5.1.1 Wear sterile gloves during sample collection.
5.1.2 Collect the fractional solution aseptically in a sterile container.
5.2 Dilution:
5.2.1 Aseptically transfer a suitable volume of the sample into a sterile diluent.
5.2.2 Mix thoroughly to ensure homogeneity.
5.3 Inoculation:
5.3.1 Inoculate the appropriate dilutions onto culture media using sterile pipettes.
5.3.2 Incubate the inoculated media at the specified temperature and duration.
5.4 Enumeration:
5.4.1 After incubation, count the colonies using a colony counter.
5.4.2 Record the colony-forming units (CFUs) per milliliter.
5.5 Reporting:
5.5.1 Compile the test results, including the bioburden count.
5.5.2 Report any deviations from the acceptance criteria.
6. Acceptance Criteria:
6.1. Purpose:
1.1 This SOP establishes the acceptance criteria for bioburden testing of fractional solutions to ensure compliance with quality standards.
6.2. Scope:
2.1 Applicable to all bioburden testing activities involving fractional solutions within the organization.
6.3. Definitions:
3.1 Bioburden: The number of viable microorganisms present in a sample.
6.4. Acceptance Criteria:
4.1 General Criteria:
4.1.1 The bioburden count should not exceed the established limits specified in regulatory guidelines. 4.1.2 No microbial contamination should be detected in the negative control samples.
4.2 Specific Criteria:
4.2.1 For [Your Industry] applications, the acceptance criteria may vary. Refer to industry-specific guidelines and standards for detailed specifications. 4.2.2 Criteria for specific microorganisms may be outlined separately based on the nature of the fractional solutions.
6.5. Sampling Plan:
5.1 Define the sampling plan based on batch size and production frequency. 5.2 Randomly select samples from different batches for bioburden testing.
6.6. Testing Methodology:
6.1 Utilize validated testing methods and procedures for bioburden determination. 6.2 Ensure testing personnel follow aseptic techniques during sample collection and testing.
6.7. Trend Analysis:
7.1 Conduct trend analysis on bioburden data over time. 7.2 Evaluate any significant variations and implement corrective actions if trends indicate a potential issue.
6.8. Deviations:
8.1 If the bioburden count exceeds the acceptance criteria, classify it as a deviation. 8.2 Initiate an investigation to determine the root cause and implement corrective actions promptly.
6.9. Reporting:
9.1 Document and report all bioburden test results, including adherence or deviation from acceptance criteria.
9.2 Maintain records in a secure and accessible manner.
6.10. Review and Approval:
10.1 QA is responsible for reviewing and approving the acceptance criteria.
10.2 Regularly review and update the acceptance criteria in consultation with relevant stakeholders.
6.11. Training:
11.1 Ensure that testing personnel are trained on the acceptance criteria and any updates.
11.2 Maintain records of training sessions.
6.12. Revision History:
12.1 Document all revisions made to the acceptance criteria.
12.2 Clearly communicate any changes to relevant personnel.
6.13. References:
13.1 List any relevant documents, guidelines, or standards referenced in this SOP.
7. Documentation:
7.1. Purpose:
1.1 This SOP outlines the documentation requirements for the bioburden testing of fractional solutions to ensure accuracy, traceability, and compliance with quality standards.
7.2. Scope:
2.1 Applicable to all documentation generated during the bioburden testing process for fractional solutions within the organization.
7.3. Documentation Requirements:
3.1 Sample Collection:
3.1.1 Record the date and time of sample collection.
3.1.2 Clearly label each sample with a unique identifier, including batch information.
3.2 Dilution and Inoculation:
3.2.1 Document the dilution factors and volumes used during the sample preparation.
3.2.2 Record the details of the inoculation process onto culture media.
3.3 Incubation:
3.3.1 Log the start and end times of the incubation period.
3.3.2 Monitor and record any unusual observations during incubation.
3.4 Enumeration:
3.4.1 Document the colony counts for each sample.
3.4.2 Include information on the method of enumeration and any specific observations.
3.5 Acceptance Criteria:
3.5.1 Clearly state the acceptance criteria applied to each bioburden test.
3.5.2 Document any deviations from the acceptance criteria.
3.6 Trend Analysis:
3.6.1 Conduct trend analysis on bioburden data over time.
3.6.2 Record any actions taken based on trend analysis results.
3.7 Deviations:
3.7.1 Document all deviations from established procedures.
3.7.2 Outline the investigation process and corrective actions taken.
3.8 Reporting:
3.8.1 Prepare a comprehensive report summarizing the bioburden testing results.
3.8.2 Include information on adherence to acceptance criteria and any deviations.
7.4. Record Keeping:
4.1 Storage:
4.1.1 Store all documents in a secure and controlled environment.
4.1.2 Ensure accessibility to authorized personnel only.
4.2 Retention Period:
4.2.1 Establish a retention period for bioburden testing documents in accordance with regulatory requirements.
4.2.2 Safely dispose of records after the designated retention period.
7.5. Review and Approval:
5.1 QA is responsible for reviewing and approving all documentation related to bioburden testing.
5.2 Conduct periodic reviews to ensure completeness and accuracy of records.
7.6. Training:
6.1 Provide training to personnel involved in documentation procedures.
6.2 Maintain records of training sessions.
7.7. Revision History:
7.1 Document all revisions made to the documentation procedures.
7.2 Clearly communicate any changes to relevant personnel.
7.8. References:
8.1 List any relevant documents, guidelines, or standards referenced in this SOP.
8. Deviation Handling:
8.1. Purpose:
1.1 This SOP outlines the procedures for identifying, documenting, investigating, and resolving deviations encountered during the testing of bioburden for fractional solutions.
8.2. Scope:
2.1 Applicable to all personnel involved in bioburden testing and quality assurance within the organization.
8.3. Definitions:
3.1 Deviation: Any departure from established procedures or acceptance criteria.
8.4. Identification of Deviation:
4.1 Personnel Responsibility:
4.1.1 All personnel involved in the bioburden testing process are responsible for promptly identifying and reporting any deviations.
4.1.2 Deviations may include, but are not limited to, equipment malfunctions, procedural errors, or unexpected observations.
4.2 Quality Assurance (QA) Notification:
4.2.1 Immediately inform the QA department of any identified deviation.
4.2.2 Provide a detailed description of the deviation, including relevant dates, times, and potential impact on testing results.
8.5. Documentation of Deviation:
5.1 Deviation Report:
5.1.1 QA will initiate a deviation report, including a unique identifier for tracking purposes.
5.1.2 Clearly document the nature of the deviation, its potential impact, and initial corrective actions taken.
5.2 Supporting Documentation:
5.2.1 Attach relevant documentation, such as photographs, data logs, or any other evidence related to the deviation.
5.2.2 Provide information on the personnel involved and the steps leading to the identification of the deviation.
8.6. Investigation:
6.1 QA-Led Investigation:
6.1.1 QA will lead a thorough investigation into the deviation.
6.1.2 Analyze root causes, involving relevant personnel and departments as necessary.
6.2 Timelines:
6.2.1 Complete the investigation within a defined timeframe, considering the urgency and potential impact on product quality.
6.2.2 Provide regular updates to relevant stakeholders during the investigation process.
8.7. Corrective Actions:
7.1 Immediate Corrective Actions:
7.1.1 Implement immediate corrective actions to address the deviation and prevent its recurrence.
7.1.2 Document these actions in the deviation report.
7.2 Preventive Actions:
7.2.1 Propose and implement preventive actions to avoid similar deviations in the future.
7.2.2 Communicate preventive measures to relevant personnel through training or procedural updates.
8.8. Review and Approval:
8.1 QA will review the completed deviation report, investigation findings, and corrective actions.
8.2 Obtain approval from relevant stakeholders before closing the deviation.
8.9. Reporting:
9.1 Communicate the resolution and outcomes of the deviation investigation to all concerned parties.
9.2 Include a summary of lessons learned and recommendations for continuous improvement.
8.10. Training:
10.1 Provide additional training to personnel involved in the deviation, emphasizing the importance of adherence to procedures.
10.2 Document training sessions and maintain records.
8.11. Revision History:
11.1 Document all revisions made to the deviation handling procedures.
11.2 Clearly communicate any changes to relevant personnel.
8.12. References:
12.1 List any relevant documents, guidelines, or standards referenced in this SOP.
9. Training:
9.1 Ensure personnel involved in testing are trained on this SOP.
9.2 Periodically review and update training records.
10. Revision History:
10.1 Maintain a record of all revisions made to this SOP.
11. References:
11.1 List any relevant documents or standards referenced in this SOP.
12. Approval:
12.1 This SOP is approved by the Quality Assurance Manager.
13. Distribution:
13.1 Distribute copies of this SOP to relevant departments.
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