documentation requirements.

2. Scope

This SOP applies to the transfer of microbiological analytical methods such as microbial enumeration, sterility testing, endotoxin testing, and antimicrobial efficacy testing between internal sites and contract laboratories.

3. Responsibilities

• SU Microbiologist: Provides method details, validation reports, reference cultures, and training to the RU.
• RU Analyst: Performs method execution under supervision and participates in comparative analysis.
• QA Officer: Ensures method documentation, regulatory compliance, and approval of the transfer report.

4. Accountability

The Microbiology Section Head in AMD is accountable for ensuring successful execution, documentation, and regulatory compliance of all microbiological method transfer activities.

5. Procedure

5.1 Pre-Transfer Requirements

1. Ensure that the method has been validated by the SU as per ICH Q2(R1).
2. Review media qualification records and environmental monitoring capabilities at RU.
3. Conduct analyst training and qualification at RU on aseptic handling and method specifics.
4. Prepare Method Transfer Protocol (refer SOP/AMD/296/2025) specific to microbiological parameters.

5.2 Method Transfer Execution

1. Use test organisms from certified sources (e.g., ATCC strains).
2. Perform method in parallel at SU and RU using identical sample batches, media, and incubation conditions.
3. Document all recovery rates, incubation logs, dilution records, and test timings.

5.3 Acceptance Criteria

• For microbial limits and enumeration:
  • Difference in CFU count between RU and SU ≤ 0.5 log₁₀
  • Recovery rate for specified organisms ≥ 70%
• For endotoxin testing:
  • Geometric mean recovery within 50–200% of labeled spike
• No contamination or false positives in sterility blanks

5.4 Documentation and Reporting

1. Compile raw data, result tables, photographs (if applicable), and microbiological media logs.
2. Complete the Method Transfer Summary Report (Annexure-3).
3. Submit report to QA for review and approval.

5.5 Troubleshooting and Deviation Handling

1. Record any method deviations in Deviation Log (Annexure-2).
2. Conduct root cause analysis for deviations using microbiological investigation tools (e.g., growth promotion testing, environmental swabs).
3. Repeat testing under corrected conditions with QA approval.

6. Abbreviations

• RU: Receiving Unit
• SU: Sending Unit
• CFU: Colony Forming Units
• GMP: Good Manufacturing Practice
• ATP: Adenosine Triphosphate (used in rapid methods)

7. Documents

1. Microbiological Method Transfer Protocol – Annexure-1
2. Deviation Log – Annexure-2
3. Method Transfer Summary Report – Annexure-3

8. References

• USP <61>, <62>, <71>, <85>, <1116>
• ICH Q2(R1): Validation of Analytical Procedures
• WHO TRS 961 Annex 7: Analytical Method Transfer

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Rekha Pillai	Pradeep Mehta	Sunita Reddy
Designation	Microbiologist	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Microbiological Method Transfer Protocol

Includes: organism list, media types, incubation parameters, method summary, analyst qualifications, acceptance criteria.

Annexure-2: Deviation Log

Deviation ID	Description	Root Cause	Corrective Action	Status
DEV-302-01	Low recovery of S. aureus	Expired TSA plate	Replaced media and repeated test	Closed

Annexure-3: Method Transfer Summary Report

Method: Bacterial Endotoxin Test
RU: Micro QC Lab – Mumbai
SU: AMD – Hyderabad
Result: Transfer Successful, all spike recoveries within 80–150% range. No deviations reported.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Expanded scope to include rapid methods and root cause protocols	Annual Review	Sunita Reddy
20/07/2022	1.0	Initial Release	New SOP	QA Head