Standard Operating Procedure for Managing Waste Byproducts in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/186/2025 |
| Supersedes | SOP/GM/186/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
This SOP is established to outline the procedures for proper identification, segregation, handling, storage, and safe disposal of waste byproducts generated during the manufacturing of gel products. The objective is to prevent contamination, minimize environmental impact, and comply with local regulatory guidelines.
2. Scope
This SOP applies to all gel manufacturing processes and associated areas where waste byproducts such as rejected gels, rinsate, packaging scraps, chemical residues, and expired raw materials are generated.
3. Responsibilities
- Production Chemist: Responsible for identifying and collecting waste during routine
operations.
EHS Officer: Ensures safe disposal and compliance with hazardous waste handling laws.
Housekeeping Staff: Support segregation, labeling, and transport of waste to designated zones.
QA Department: Audits waste management practices and records.
4. Accountability
The Head – Manufacturing is accountable for ensuring implementation of this SOP and facilitating continual improvements in waste management efficiency across the department.
5. Procedure
5.1 Identification and Classification of Waste
- Classify waste into the following categories:
- Hazardous chemical waste
- Non-hazardous organic or inorganic waste
- Packaging waste (blister foils, tubes, containers)
- General waste (paper, plastics, PPE)
- Biological or microbiological waste (where applicable)
- Use Annexure-1 for waste classification guidelines.
5.2 Waste Collection and Segregation
- Provide color-coded bins as per CPCB norms:
- Red: Contaminated plastics and packaging
- Yellow: Chemical and hazardous gel residues
- Green: Biodegradable organic waste
- Blue: Recyclable packaging
- Black: General non-hazardous waste
- Ensure lids are always closed and bins are clearly labeled with the waste type.
- Reject gel batches must be collected in leak-proof drums with proper labeling and stored under restricted access until final disposal.
5.3 Temporary Storage and Handling
- Designate a secured and ventilated waste storage area within the facility.
- Hazardous waste must be stored separately and not exceed the regulatory limit of 90 days.
- Use PPE during handling of any waste streams.
5.4 Waste Disposal
- Authorized vendors should be contracted for final disposal of hazardous and recyclable waste.
- Send expired raw materials and solvent-based residues to incinerators certified by the State Pollution Control Board.
- Perform manifest documentation before and after disposal.
5.5 Documentation and Records
- Maintain waste movement log as per Annexure-2.
- QA must retain waste disposal records for a minimum of 5 years.
- Conduct internal audits quarterly to verify proper waste segregation and disposal.
5.6 Emergency Procedures
- In case of a waste spill, use containment kits and report to EHS Officer immediately.
- Train all personnel on emergency response for hazardous waste incidents.
6. Abbreviations
- SOP: Standard Operating Procedure
- EHS: Environment, Health, and Safety
- PPE: Personal Protective Equipment
- CPCB: Central Pollution Control Board
7. Documents
- Waste Classification Reference Chart – Annexure-1
- Waste Movement Log Sheet – Annexure-2
- Hazardous Waste Manifest Form – Annexure-3
- Monthly Disposal Summary Sheet – Annexure-4
- Emergency Spill Response Checklist – Annexure-5
8. References
- Biomedical Waste Management Rules, India – 2016 (as amended)
- CPCB Guidelines on Management of Hazardous Waste
- WHO Guidelines on Waste Management in Pharmaceutical Production
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Waste Classification Reference Chart
| Type of Waste | Category | Example |
|---|---|---|
| Chemical Gel Residue | Hazardous | Solvent-rich gel rejects |
| Empty Containers | Recyclable | HDPE, PET bottles |
| Expired APIs | Hazardous | Degraded drug substances |
Annexure-2: Waste Movement Log Sheet
| Date | Waste Type | Quantity | Bin/Drum No. | Disposal Status |
|---|---|---|---|---|
Annexure-3: Hazardous Waste Manifest Form
(As per CPCB Format)
Annexure-4: Monthly Disposal Summary Sheet
| Month | Total Waste (kg) | Disposed (kg) | Pending Disposal |
|---|---|---|---|
Annexure-5: Emergency Spill Response Checklist
- Notify EHS Officer immediately
- Isolate the spill area
- Use containment kits (absorbents, PPE)
- Document incident and root cause
Revision History
| Revision Date | Revision No. | Description of Change | Reason | Approved By |
|---|---|---|---|---|
| 02/04/2022 | 1.0 | Initial release | New procedure | QA Head |
| 09/06/2025 | 2.0 | Expanded with CPCB compliance and emergency checklist | Regulatory update | QA Head |