audit purposes.

3. Responsibilities

• Bioanalytical Scientist: Identifies samples eligible for disposal and documents disposal request.
• Lab Technician: Carries out physical disposal following biosafety and environmental regulations.
• QA Officer: Reviews disposal records and ensures compliance with applicable guidelines.
• Facility Manager: Ensures coordination with biomedical waste disposal vendors.

4. Accountability

The Head of the Bioanalytical Department is accountable for ensuring that all used biological samples are disposed of safely and in accordance with SOPs and regulatory requirements.

5. Procedure

5.1 Identification of Samples for Disposal

1. Samples eligible for disposal include:
   • Samples beyond the reanalysis period (typically 3 months after study report finalization)
   • Samples declared non-usable due to stability loss or contamination
2. The study scientist generates a Sample Disposal Request Form (Annexure-1) and submits it to QA for approval.

5.2 Approval and Documentation

1. QA reviews:
   • Study closure documentation
   • Audit or reanalysis status
   • Regulatory retention period
2. Upon confirmation, QA signs off the Sample Disposal Request Form.
3. Disposal is documented in the Biological Sample Disposal Log (Annexure-2).

5.3 Segregation and Handling

1. Samples for disposal are segregated in biohazard bags or puncture-proof containers labeled “For Disposal.”
2. Frozen samples are thawed in a designated biosafety area.
3. Personnel must wear gloves, lab coat, and protective eyewear during handling.

5.4 Disposal Method

1. Samples are disposed via:
   • Incineration in authorized biomedical waste incinerators
   • Autoclaving followed by landfill, as per local biomedical waste rules
2. Disposal must be performed in the presence of at least two witnesses (one from QA).
3. Vendor-signed disposal certificate must be obtained and attached to Annexure-2.

5.5 Compliance and Audit Readiness

1. All disposal activities must be audit-traceable.
2. Retention of logs and certificates for at least 5 years.
3. QA shall periodically review disposal practices for continuous compliance.

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• BMW: Biomedical Waste
• CoA: Certificate of Analysis

7. Documents

1. Sample Disposal Request Form – Annexure-1
2. Biological Sample Disposal Log – Annexure-2
3. Disposal Certificate from Authorized Vendor – Annexure-3

8. References

• Biomedical Waste Management Rules, 2016 (India)
• ICH GCP E6(R2)
• US FDA GLP Guidance for Bioanalytical Methods

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 Disposal Request Form

Study Code	BE/XYZ/2025/06
No. of Samples	1200
Disposal Reason	Post-analysis storage period completed
Requested By	Rajesh Kumar
Approved By	Sunita Reddy (QA)
Request Date	15/04/2025

Annexure-2: Biological Sample Disposal Log

Date	Study Code	Sample Count	Disposed By	QA Witness
17/04/2025	BE/XYZ/2025/06	1200	Ajay Verma	Sunita Reddy

Annexure-3: Disposal Certificate

Vendor Name	GreenMed Waste Disposal Services
Date	17/04/2025
Certificate No.	GM-INV-0568
Signature & Stamp	[Vendor Signature]

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
17/04/2025	2.0	Updated disposal process and audit log requirements	Regulatory Alignment	QA Head