Standard Operating Procedure for Review of Microbial Testing Reports

Department	Tablet
SOP No.	SOP/TAB/210/2025
Supersedes	SOP/TAB/210/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

This SOP outlines the procedure for reviewing microbial testing reports in the tablet manufacturing department. It ensures that microbial testing is conducted in accordance with GMP and regulatory standards, and that results are accurately reviewed to maintain product safety and quality.

2. Scope

This SOP applies to all microbial testing performed on raw materials, in-process materials, and finished tablet products within the tablet manufacturing department. It covers the review process for all microbial testing reports to ensure compliance with FDA and internal standards.

3. Responsibilities

• Quality Assurance (QA) Manager: Responsible for overseeing the review of microbial testing reports and ensuring that they meet regulatory requirements.
• Microbial Testing Team: Responsible for conducting microbial tests and preparing accurate reports for review.
• Production Team: Responsible for adhering to microbial testing procedures and maintaining proper sanitation practices to prevent contamination.
• Regulatory Affairs Team: Ensures that microbial testing practices comply with FDA guidelines and other relevant regulations.

4. Accountability

The QA Manager is accountable for overseeing the microbial testing report review process. The Microbial Testing Team is responsible for performing the tests and preparing reports, while the Production Team ensures cleanliness and compliance during the manufacturing process.

5. Procedure

5.1 Microbial Testing Procedures

1. Ensure that microbial testing procedures are in place for raw materials, in-process materials, and finished products.
2. The Microbial Testing Team must follow FDA-approved testing methods, such as plate counts, yeast and mold testing, and total aerobic microbial counts.
3. Ensure that proper testing equipment and supplies are available and calibrated as required by the procedures.
4. Document all microbial testing procedures, including batch numbers, test methods, and sampling locations (Annexure-1).

5.2 Review of Microbial Testing Reports

1. The QA Manager is responsible for reviewing the microbial testing reports within a specified timeframe, ensuring that the results are documented accurately and that they meet predefined acceptance criteria.
2. Review the following aspects during the report review:
   • Test methodology used and its compliance with regulatory guidelines.
   • Correct identification of microbial organisms and accurate quantification.
   • Comparison of results with predefined acceptance criteria for the product (Annexure-2).
3. If any discrepancies or deviations are found in the report, initiate an investigation and document the findings (Annexure-3).

5.3 Action for Out-of-Specification (OOS) Results

1. If the microbial testing results do not meet the acceptance criteria, QA must initiate an investigation into the root cause of the failure.
2. Review the testing procedure to ensure that the failure is not due to human error, contamination during testing, or equipment malfunction.
3. If necessary, take corrective actions, such as re-testing, implementing new testing methods, or modifying the manufacturing process to prevent further contamination (Annexure-4).
4. Ensure that all actions taken in response to OOS results are documented and that a final report is submitted for approval (Annexure-5).

5.4 Final Approval of Microbial Testing Reports

1. Once the microbial testing report has been reviewed and all discrepancies have been addressed, QA will provide final approval for the report (Annexure-6).
2. Ensure that the report is signed off by the QA Manager and filed in the appropriate records for future reference and audits.
3. If the microbial testing results meet all acceptance criteria, proceed with product release for further processing or distribution.

5.5 Documentation and Record Keeping

1. Ensure that all microbial testing reports are properly documented and stored for the required retention period, as per FDA and internal guidelines.
2. All test results must be archived in both physical and electronic formats for ease of access during audits or inspections (Annexure-7).
3. Maintain records of all deviations, corrective actions, and OOS investigations related to microbial testing.

5.6 Review of Testing Practices

1. Review microbial testing practices periodically to ensure they remain in compliance with current FDA guidelines and industry standards.
2. Implement necessary updates or improvements to testing protocols, equipment, or procedures to enhance accuracy and efficiency.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• OOS: Out of Specification
• FDA: Food and Drug Administration
• GMP: Good Manufacturing Practice

7. Documents

1. Microbial Testing Procedure Documentation (Annexure-1)
2. Microbial Testing Report Review Checklist (Annexure-2)
3. Deviation and OOS Investigation Report (Annexure-3)
4. Corrective Action Plan (Annexure-4)
5. Final Testing Report (Annexure-5)
6. Approval of Microbial Testing Report (Annexure-6)
7. Microbial Testing Records Archive (Annexure-7)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• USP <61> – Microbial Limit Tests
• USP <62> – Tests for Specific Microorganisms
• FDA Guidelines for Microbial Testing in Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Microbial Testing Procedure Documentation

Test Type	Methodology	Acceptance Criteria	Frequency
Total Aerobic Count	Plate Count	Less than 100 CFU/g	Every Batch

Annexure-2: Microbial Testing Report Review Checklist

Test Date	Batch Number	Test Parameters	Compliance Status
01/03/2026	Batch-12345	Aerobic Count, Yeast, Mold	Pass

Annexure-3: Deviation and OOS Investigation Report

Deviation ID	Deviation Description	Investigation Outcome	Corrective Action Taken
DEV-001	Microbial Count Exceeded Limit	Investigated equipment contamination	Recalibrated equipment and retested

Annexure-4: Corrective Action Plan

Action ID	Action Description	Responsible Person	Completion Date
CAP-001	Recalibrate testing equipment	John Doe	05/03/2026

Annexure-5: Final Testing Report

Test Type	Result	Acceptance Criteria	Compliance Status
Aerobic Count	50 CFU/g	Less than 100 CFU/g	Pass

Annexure-6: Microbial Testing Approval Log

Approval ID	Approved By	Approval Date
APP-001	QA Manager	06/03/2026

Annexure-7: Microbial Testing Records Archive

Document	File Location	Retention Period
Microbial Testing Reports	Document Archive A	5 years

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated microbial testing procedures	Clarified review process	QA Head