Control (QC) laboratory for routine execution in compliance with GMP and pharmacopeial standards.

2. Scope

This SOP is applicable to all validated sterility testing methods developed for sterile finished products or components in the AMD department intended to be executed routinely by the QC Microbiology laboratory.

3. Responsibilities

• AMD Microbiologist: Prepares the transfer protocol and shares validated method details with QC.
• QC Analyst: Executes transferred method under supervision during demonstration runs.
• AMD Supervisor: Reviews readiness and issues Transfer Completion Report.
• QA Executive: Ensures traceability and regulatory compliance of transfer documentation.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring complete and successful transfer of sterility methods to QC, supported by comprehensive documentation, training, and verification.

5. Procedure

5.1 Preparation of Method Transfer Protocol

1. Include the following in the protocol:
   • Method principle and objective
   • Sample and media requirements
   • Test organisms and challenge conditions
   • Acceptance criteria
2. Obtain approval from AMD, QC, and QA before initiation.

5.2 Method Demonstration

1. AMD personnel demonstrate:
   • Membrane filtration or direct inoculation technique
   • Use of isolator or sterility testing isolator/glove box
   • Positive control handling
2. QC personnel perform at least three supervised runs using:
   • Positive controls (e.g., B. subtilis, C. albicans)
   • Negative controls (media blanks)

5.3 Comparative Evaluation

1. Compare QC results with AMD historical performance using:
   • Contamination rate
   • Incubation uniformity
   • Recovery confirmation
2. Record findings in Annexure-2.

5.4 Documentation and Completion

1. Prepare Method Transfer Report including:
   • Training attendance records
   • Protocol compliance summary
   • Any deviations or observations
2. Obtain final QA approval and file all records as per GMP retention policy.

6. Abbreviations

• AMD: Analytical Method Development
• QC: Quality Control
• QA: Quality Assurance
• CFU: Colony Forming Units
• SOP: Standard Operating Procedure

7. Documents

1. Sterility Method Transfer Protocol – Annexure-1
2. Comparative Test Data Sheet – Annexure-2
3. Method Transfer Completion Report – Annexure-3

8. References

• USP <71> Sterility Tests
• Ph. Eur. 2.6.1 Sterility
• ICH Q4B Annex 8 – Sterility Test
• WHO Technical Report Series 961

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Dr. Meenal Raut	Yash Mehra	Sunita Reddy
Designation	Microbiologist	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Sterility Method Transfer Protocol

Method Type	Organism Panel	Incubation Temp	Incubation Time
Membrane Filtration	B. subtilis, C. albicans	20–25°C / 30–35°C	14 Days

Annexure-2: Comparative Test Data

Test Run	Contamination Rate (QC)	Contamination Rate (AMD)	Status
Run 1	0%	0%	Acceptable

Annexure-3: Method Transfer Completion Report

The sterility testing method was successfully transferred to QC. All demonstration runs were completed without deviations. Recovery rates and contamination profiles matched AMD records. QC team trained and certified. Method is ready for routine implementation.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Included criteria for method comparison and QA completion	Annual Review and Tech Transfer Audit	Sunita Reddy
12/05/2022	1.0	Initial SOP Release	New SOP	QA Head