all types of waste generated in sterile manufacturing areas including:

• Non-hazardous and general waste
• Hazardous waste (e.g., chemical residues, cleaning solvents)
• Biomedical waste (e.g., used PPE, microbial samples)
• Sharps and broken glass
• Packaging waste

3. Responsibilities

• Manufacturing Operators: Segregate and label waste properly at the source.
• Production Supervisor: Ensure daily disposal and log maintenance.
• QA Executive: Audit waste handling and ensure regulatory compliance.
• EHS Officer: Arrange final disposal and maintain disposal records.

4. Accountability

The Head of Manufacturing and EHS Head are jointly accountable for compliance with this SOP.

5. Procedure

5.1 Waste Classification

1. Classify waste into the following categories:
   • Solid General Waste: Packaging materials, PPE, used documents
   • Liquid Waste: Unused solutions, rinses
   • Chemical Waste: Residuals of cleaning agents or solvents
   • Biohazard Waste: Microbiological testing leftovers
   • Sharps: Broken glass, needles

5.2 Waste Segregation

1. Use color-coded bins:
   • Yellow: Infectious waste
   • Red: Plastic waste (autoclavable)
   • White (puncture proof): Sharps
   • Black: General waste
2. Do not mix waste types in the same container.

5.3 Waste Labeling

1. Affix a “WASTE” label on all bins and bags with the following:
   • Date of collection
   • Type of waste
   • Operator initials

5.4 Waste Storage

1. Store segregated waste in designated waste holding areas.
2. Ensure temporary storage does not exceed 48 hours.

5.5 Waste Disposal

1. Dispose of general waste through approved municipal services.
2. Hazardous waste to be sent to certified incineration or disposal contractors.
3. Autoclave biohazard waste before disposal.
4. Document disposal in the Waste Disposal Register (Annexure-1).

5.6 Cleaning of Waste Areas

1. Clean waste bins with 0.5% sodium hypochlorite daily.
2. Disinfect storage areas weekly using appropriate agents.

5.7 Emergency Handling

1. In case of spill:
   • Evacuate non-involved personnel.
   • Wear appropriate PPE.
   • Contain and neutralize chemical spills as per MSDS.
   • Report the incident to the EHS team immediately.

6. Abbreviations

• SOP: Standard Operating Procedure
• EHS: Environment, Health & Safety
• MSDS: Material Safety Data Sheet
• PPE: Personal Protective Equipment

7. Documents

1. Waste Disposal Register – Annexure-1
2. Biohazard Waste Autoclave Log – Annexure-2
3. Chemical Spill Report – Annexure-3

8. References

• Biomedical Waste Management Rules, 2016 (India)
• ICH Q9 – Quality Risk Management
• WHO GMP Guidelines for Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Waste Disposal Register

Date	Waste Type	Quantity	Disposal Method	Disposed By
23/06/2025	General Waste	25 kg	Municipal	Ramesh Kumar

Annexure-2: Biohazard Waste Autoclave Log

Date	Waste Description	Autoclave Time	Temperature	Verified By
22/06/2025	Used Swabs	45 min	121°C	Sunita Reddy

Annexure-3: Chemical Spill Report

Date	Location	Description	Action Taken	Reported By
20/06/2025	Dispensing Booth	Acetic acid spill	Neutralized and cleaned	Ajay Mehta

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/04/2022	1.0	Initial release	New SOP	QA Head
24/06/2025	2.0	Added chemical spill response and annexure	Annual Review	QA Head