the clinical and bioanalytical units.

3. Responsibilities

• Clinical Staff: Disposes of biological waste in correct color-coded containers immediately after use.
• Housekeeping Personnel: Collects waste daily, ensures secure sealing and storage, and updates tracking log.
• Facility Manager: Coordinates disposal with authorized biomedical waste vendor.
• QA Officer: Verifies waste disposal records and vendor compliance certificates.

4. Accountability

The Head of Clinical Operations is accountable for ensuring that all biological waste is handled, stored, tracked, and disposed of in a safe and regulatory-compliant manner.

5. Procedure

5.1 Waste Segregation and Collection

1. Place color-coded bins in all sample collection, dosing, processing, and disposal areas:
   • Yellow bags – Human anatomical waste, contaminated gauze, dressings
   • Red bags – Tubes, catheters, syringes (without needles)
   • White puncture-proof containers – Needles and sharps
   • Blue bins – Glassware (e.g., vacutainers)
2. Immediately place used material in designated bins. Do not leave unattended or outside containers.

5.2 Labeling and Sealing

1. Label all bins with:
   • Date of generation
   • Department name
   • Shift details
2. Seal bags or containers once 3/4th full or at end of shift using tamper-proof ties or lids.

5.3 Interim Storage

1. Transfer sealed containers to the biomedical waste room, which should:
   • Be locked and access-controlled
   • Be ventilated and separate from sample storage areas
2. Record transfer in Annexure-1: Biomedical Waste Tracking Log.

5.4 Handover to Authorized Vendor

1. Vendor collection must occur daily or as per contract terms.
2. Check vendor credentials (CPCB/BMW Authorization certificate).
3. Hand over sealed bags and collect waste manifest copies (Annexure-2: Disposal Acknowledgment Form).

5.5 Documentation and Review

1. Maintain all manifest and tracking logs for a minimum of 3 years.
2. QA to conduct monthly audits using Annexure-3: Waste Compliance Audit Sheet.

5.6 Spill Management (if applicable)

1. In case of accidental spills:
   • Isolate area
   • Use PPE and absorbents to clean spill
   • Disinfect with 0.5% hypochlorite
   • Report using Annexure-4: Spill Incident Report

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• QA: Quality Assurance
• BMW: Biomedical Waste
• CPCB: Central Pollution Control Board
• PPE: Personal Protective Equipment

7. Documents

1. Biomedical Waste Tracking Log – Annexure-1
2. Disposal Acknowledgment Form – Annexure-2
3. Waste Compliance Audit Sheet – Annexure-3
4. Spill Incident Report – Annexure-4

8. References

• Biomedical Waste Management Rules, 2016 (India)
• WHO Guidelines on Healthcare Waste Management
• ICH E6(R2) – Good Clinical Practice

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Biomedical Waste Tracking Log

Date	Shift	Bag Color	Qty	Stored By	Verified By
17/04/2025	Morning	Yellow	5	Sunita Reddy	Rajesh Kumar

Annexure-2: Disposal Acknowledgment Form

Date	Vendor Name	BMW Certificate No.	No. of Bags	Signature
17/04/2025	EcoMed Waste Services	CPCB/MH/2025/042	12	Signed

Annexure-3: Waste Compliance Audit Sheet

Audit Date	Auditor	Findings	Corrective Actions
15/04/2025	Meena Joshi	Sharps found in red bag	Staff re-trained on segregation

Annexure-4: Spill Incident Report

Date	Area	Description	Root Cause	CAPA
16/04/2025	Sample Room	Vial spill during transfer	Loose cap	Improved container checks

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial Release	Regulatory Compliance	QA Head
17/04/2025	2.0	Annexures added; vendor compliance and spill management incorporated	Audit Observation	QA Head