and compliance with GMP and GLP practices.

2. Scope

This SOP applies to all microbiological samples received in the Analytical Method Development (AMD) laboratory for routine testing, validation, environmental monitoring, sterility assessment, and preservative efficacy studies.

3. Responsibilities

• Microbiologist: Receives and documents the sample, performs integrity checks, and executes testing as per approved method.
• Analytical Scientist: Ensures proper labeling and transfer of samples from production or R&D units.
• QA Officer: Reviews sample traceability, storage records, and compliance with regulatory standards.
• Head – AMD: Verifies sample chain of custody and ensures that the handling procedure is followed rigorously.

4. Accountability

The Head of Analytical Method Development is accountable for maintaining the quality and integrity of all microbiological samples throughout the handling and testing lifecycle.

5. Procedure

5.1 Sample Receipt and Verification

1. Ensure all samples are received in clean, leak-proof, and sterile containers with tamper-evident seals.
2. Verify sample labeling: Sample ID, product name, batch number, date of collection, collected by, and test requested.
3. Cross-check the sample request form (SRF) with the physical sample.
4. Record details in Annexure-1: Sample Receipt Log.

5.2 Labeling and Identification

1. Assign a unique lab sample code using the format: MB/YY/XXX (e.g., MB/25/031).
2. Label each container with the assigned code using waterproof marker or pre-printed barcoded label.
3. Update internal sample tracking system/database.

5.3 Storage of Samples

1. Store samples under appropriate conditions:
   • Refrigerated (2–8°C) for preservative efficacy and microbial limit testing
   • Ambient (15–25°C) for water and surface swab samples
   • Frozen (−20°C or −80°C) for long-term reference storage (if required)
2. Log storage location in Annexure-2: Sample Storage Record.

5.4 Handling and Aseptic Technique

1. Handle all samples within a certified laminar airflow workstation using aseptic techniques.
2. Use sterile tools and wear appropriate PPE: gloves, gown, mask, and hair cover.
3. Do not open or manipulate samples outside designated microbiological areas.
4. Minimize handling time to reduce risk of contamination or degradation.

5.5 Sample Usage and Disposal

1. Use only the required quantity for each test as per protocol.
2. Record quantity drawn, date of testing, and analyst name in Annexure-3: Sample Usage Log.
3. Dispose of unused or expired samples following the laboratory’s biohazard waste disposal policy.
4. Update sample status as “Consumed,” “Retained,” or “Discarded.”

5.6 Chain of Custody and Documentation

1. Ensure all steps from receipt to disposal are documented for traceability.
2. In case of sample rejection (damaged, missing info, expired), log reason in Annexure-4: Sample Rejection Log.
3. Retain all logs for a minimum of 5 years as per GMP documentation requirements.

6. Abbreviations

• GMP: Good Manufacturing Practice
• GLP: Good Laboratory Practice
• SRF: Sample Request Form
• AMD: Analytical Method Development
• SOP: Standard Operating Procedure

7. Documents

1. Sample Receipt Log – Annexure-1
2. Sample Storage Record – Annexure-2
3. Sample Usage Log – Annexure-3
4. Sample Rejection Log – Annexure-4

8. References

• WHO Technical Report Series 986 – GMP Guidelines
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
• EU Annex 1 – Manufacture of Sterile Medicinal Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sample Receipt Log

Date	Sample ID	Batch No.	Received From	Condition
18/05/2025	MB/25/031	B1234	Formulation R&D	Acceptable

Annexure-2: Sample Storage Record

Sample ID	Storage Location	Temperature	Stored By
MB/25/031	Micro Lab Fridge 1	2–8°C	Rajesh Kumar

Annexure-3: Sample Usage Log

Date	Sample ID	Test Performed	Quantity Used	Analyst
19/05/2025	MB/25/031	MLT	5 mL	Sunita Reddy

Annexure-4: Sample Rejection Log

Date	Sample ID	Reason for Rejection	Action Taken
—	—	—	—

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
04/05/2025	2.0	Updated to include barcode labeling and disposal traceability	Annual Review