Standard Operating Procedure for Use of Color Coding in Gel Manufacturing Areas
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/127/2025 |
| Supersedes | SOP/GM/127/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To describe the procedure for implementing and maintaining a standardized color coding system in the gel manufacturing area to enhance operational efficiency, ensure material identification, and avoid cross-contamination.
2. Scope
This SOP applies to all equipment, pipelines, containers, garments,
labels, and zones within the gel manufacturing department where color coding is employed.
3. Responsibilities
- Production Personnel: Adhere to color coding guidelines during manufacturing operations.
- Engineering Team: Ensure correct painting and labeling of pipelines and equipment as per color code.
- Quality Assurance: Verify compliance with the color coding policy during area and equipment audits.
4. Accountability
Department Head – Gel Manufacturing
5. Procedure
5.1 Color Coding Guidelines
The following standardized color coding shall be used:
| Item | Color Code | Purpose |
|---|---|---|
| Purified Water Lines | Sky Blue | Indicates water pipeline |
| Compressed Air Lines | Yellow | Compressed air pipeline |
| Steam Lines | Red | Live steam pipeline |
| Vacuum Lines | Grey | Vacuum pipeline |
| Product Contact Equipment | Green | Indicates clean contact surfaces |
| Non-product Contact Equipment | White | Indicates general utilities |
| Reject Materials | Black | Identification of rejected items |
| Clean Garments | Blue | Indicates cleanroom attire |
| Used Garments | Brown | Garments awaiting laundering |
| Labels for Raw Materials | Pink | Easy identification of RM |
| Labels for Intermediates | Yellow | In-process material ID |
| Labels for Finished Product | White | Release status and traceability |
5.2 Implementation
- Ensure painting or tagging of all items using durable, non-toxic, and heat-resistant color coatings.
- Display a laminated color code chart at entry points and key manufacturing areas.
- Ensure personnel are trained on the correct interpretation and usage of the color coding scheme.
5.3 Maintenance and Audit
- Engineering team to inspect and refresh color markings every 6 months.
- QA to verify compliance with SOP during routine audits and deviation investigations.
5.4 Deviations
- Any observed deviation from color coding must be immediately reported to QA.
- Record deviation in the Non-Conformance Register and take corrective actions.
6. Abbreviations
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- RM: Raw Material
7. Documents
- Color Coding Display Chart – Annexure-1
- Line and Equipment Color Coding Checklist – Annexure-2
8. References
- IS 2379: Color code for identification of pipelines
- WHO GMP Guidelines
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: Color Coding Display Chart
| Area | Item | Color Code |
|---|---|---|
| Manufacturing Area | Water Lines | Sky Blue |
| Utilities | Steam | Red |
| Personnel | Clean Garments | Blue |
Annexure-2: Color Coding Checklist
| Item | Color as per SOP | Observed Color | Status | Remarks |
|---|---|---|---|---|
| Purified Water Pipeline | Sky Blue | |||
| Clean Garment Bin | Blue | |||
| Label for Finished Product | White |
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 01/03/2022 | 1.0 | Initial version | New SOP | QA Head |
| 09/06/2025 | 2.0 | Added pipeline and garment codes | Compliance & Visual Controls | QA Head |