ensures compliance with regulatory standards and approves any deviations from standard procedures.

5. Procedure

5.1 Identification and Classification of Materials

1. Materials Requiring Special Testing:
   • Sterile Active Pharmaceutical Ingredients (APIs)
   • Excipients prone to microbial contamination
   • Water-sensitive materials requiring endotoxin testing
   • Herbal and natural products requiring bioburden testing
2. Labeling Requirements:
   • Clearly label materials with the following:
     • Material Name
     • Batch/Lot Number
     • “Requires Microbiological Testing” indicator
     • Special storage instructions (e.g., “Store in sterile conditions”)

5.2 Storage Procedures

1. Storage Conditions:
   • Store materials in a dedicated, temperature-controlled quarantine area designed for microbiological-sensitive products.
   • Ensure materials are kept in sealed, sterile packaging until sampling.
   • Document storage details in the Microbiological Material Storage Log (Annexure-1).
2. Segregation of Materials:
   • Segregate materials requiring microbiological testing from non-sensitive raw materials.
   • Label storage zones accordingly to prevent cross-contamination.

5.3 Sampling Procedures

1. Preparation for Sampling:
   • Perform sampling in a dedicated cleanroom or aseptic sampling booth.
   • Use sterile, single-use sampling tools to prevent contamination.
   • Ensure all sampling equipment is pre-sterilized and documented in the Equipment Sterilization Log (Annexure-2).
2. Sampling Process:
   • Wear appropriate PPE, including sterile gloves, gowns, masks, and face shields.
   • Disinfect the outer packaging before opening in the cleanroom.
   • Collect the sample using aseptic techniques and transfer it to sterile containers.
   • Seal and label the sample containers immediately after collection.
   • Document sampling details in the Microbiological Sampling Log (Annexure-3).

5.4 Microbiological Testing Procedures

1. Types of Tests:
   • Bioburden Testing: Determine the microbial load of the material using standard plate count methods.
   • Endotoxin Testing: Use the Limulus Amebocyte Lysate (LAL) test for endotoxin detection in water-sensitive materials.
   • Sterility Testing: Perform sterility tests on materials labeled as sterile, following pharmacopeial guidelines.
2. Documentation of Test Results:
   • Record all test results in the Microbiological Test Result Log (Annexure-4).
   • Report any out-of-specification (OOS) results immediately to the QA Manager.

5.5 Handling Deviations in Microbiological Testing

1. Deviation Reporting:
   • Document any deviations in sampling, storage, or testing procedures in the Microbiological Deviation Report (Annexure-5).
   • Report OOS results to the QA Manager immediately for investigation.
2. Corrective Actions:
   • Conduct a root cause analysis to identify sources of contamination or procedural lapses.
   • Implement corrective actions and document them in the Corrective Action Log (Annexure-6).

5.6 Training and Compliance

1. Personnel Training:
   • All personnel involved in handling and testing microbiological-sensitive materials must be trained in aseptic techniques and microbiological testing procedures.
   • Document training in the Training Log (Annexure-7).
2. Compliance Monitoring:
   • QA must conduct periodic audits of microbiological handling procedures to ensure compliance.
   • Document audit findings in the Compliance Audit Log (Annexure-8).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment
• OOS: Out-of-Specification
• LAL: Limulus Amebocyte Lysate

7. Documents

1. Microbiological Material Storage Log (Annexure-1)
2. Equipment Sterilization Log (Annexure-2)
3. Microbiological Sampling Log (Annexure-3)
4. Microbiological Test Result Log (Annexure-4)
5. Microbiological Deviation Report (Annexure-5)
6. Corrective Action Log (Annexure-6)
7. Training Log (Annexure-7)
8. Compliance Audit Log (Annexure-8)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• USP <61>, <62>, <85> – Microbiological Examination of Non-Sterile Products, Endotoxin Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Microbiological Material Storage Log

Date	Material Name	Batch Number	Storage Location	Stored By
01/02/2025	Sterile API-X	API-X-2025-001	Sterile Storage Area A	Ravi Kumar

Annexure-2: Equipment Sterilization Log

Date	Equipment Name	Sterilization Method	Sterilized By	Verified By (QA)
01/02/2025	Sampling Pipette	Autoclaving	Sunita Sharma	Anjali Mehta

Annexure-3: Microbiological Sampling Log

Date	Material Name	Batch Number	Sampled By	Verified By (QA)
02/02/2025	Sterile API-X	API-X-2025-001	Ajay Singh	Anjali Mehta

Annexure-4: Microbiological Test Result Log

Date	Material Name	Batch Number	Test Performed	Result	Tested By
03/02/2025	Sterile API-X	API-X-2025-001	Bioburden Testing	Within Limits	Sunita Sharma

Annexure-5: Microbiological Deviation Report

Date	Material Name	Batch Number	Deviation Description	Reported By
03/02/2025	Sterile API-X	API-X-2025-001	Microbial Contamination Detected	Ajay Singh

Annexure-6: Corrective Action Log

Date	Deviation Description	Corrective Action	Implemented By	Verified By (QA)
04/02/2025	Microbial Contamination	Revised Aseptic Sampling Procedure	Ravi Kumar	Anjali Mehta

Annexure-7: Training Log

Date	Training Topic	Trainer	Attendee Name	Signature
05/02/2025	Aseptic Sampling and Microbiological Testing	Health & Safety Officer	Sunita Sharma

Annexure-8: Compliance Audit Log

Date	Audit Type	Findings	Corrective Actions Taken	Audited By
06/02/2025	Microbiological Compliance Audit	Non-Sterile Equipment Detected	Revised Equipment Sterilization SOP	Anjali Mehta

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated Microbiological Testing and Handling Procedures	Regulatory Compliance	QA Head