SOP Guide for Pharma

Gel Manufacturing: SOP for Use of Color Coding in Gel Manufacturing Areas – V 2.0

Gel Manufacturing: SOP for Use of Color Coding in Gel Manufacturing Areas – V 2.0

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

  1. Ensure painting or tagging of all items using durable, non-toxic, and heat-resistant color coatings.
  2. Display a laminated color code chart at entry points and key manufacturing areas.
  3. Ensure personnel are trained on the correct interpretation and usage of the color coding scheme.

5.3 Maintenance and Audit

  1. Engineering team to inspect and refresh color markings every 6 months.
  2. QA to verify compliance with SOP during routine audits and deviation investigations.

5.4 Deviations

  1. Any observed deviation from color coding must be immediately reported to QA.
  2. 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

  1. Color Coding Display Chart – Annexure-1
  2. 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
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