SOP Guide for Pharma

SOP for Handling Raw Materials with Special Microbiological Testing Requirements – V 2.0

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SOP for Handling Raw Materials with Special Microbiological Testing Requirements – V 2.0

Standard Operating Procedure for Handling Raw Materials with Special Microbiological Testing Requirements

Department Quality Control / Quality Assurance / Microbiology
SOP No. SOP/RM/084/2025
Supersedes SOP/RM/084/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for handling raw materials that require special microbiological testing, ensuring their integrity and preventing contamination throughout the quarantine and testing processes. This SOP aligns with Good Manufacturing Practices (GMP) and regulatory guidelines.

2. Scope

This SOP applies to all raw materials received and stored in the quarantine area that require microbiological testing, including but not limited to, sterile APIs, excipients sensitive to microbial contamination, and materials requiring bioburden or endotoxin testing.

3. Responsibilities

4. Accountability

The Microbiology Manager is responsible for ensuring that microbiological testing and aseptic handling procedures are followed correctly. The QA Manager 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”)
See also  SOP for Cleaning and Sanitization of Quarantine Storage Units - V 2.0

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.

See also  SOP for Routine Checks for Material Integrity in Storage - V 2.0

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

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

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
See also  SOP for Inspection and Receiving of API, Excipients, and Additives - V 2.0
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