Elixir Department: SOP for Identification and Labeling of Clean Equipment – V 2.0

Auditor

7 months ago

Standard Operating Procedure for Identification and Labeling of Clean Equipment in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/183/2025
Supersedes	SOP/ELX/183/2022
Page No.	Page 1 of 9
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To establish a standardized procedure for the identification, labeling, and status management of cleaned equipment in the Elixir Manufacturing Department to ensure traceability, readiness for use, and compliance with GMP.

2. Scope

This SOP applies to all cleaned production equipment, utensils, transfer lines, vessels, and associated accessories used in the Elixir Department, including product-contact and non-product-contact components.

3. Responsibilities

Production Operator:
- Affix appropriate “CLEANED” labels immediately after cleaning.
QA Officer:
- Verify cleaning status before release and confirm labeling accuracy.
Production Supervisor:
- Ensure equipment status is updated in the logbook and on physical labels.

4. Accountability

The Production Head is accountable for ensuring equipment is properly labeled after cleaning. QA is responsible for status verification and releasing equipment for use.

5. Procedure

5.1 Label Types and Specifications

CLEANED:

Green label indicating equipment is cleaned and ready for use.

IN USE: Blue label indicating equipment is currently being used in a batch.

TO BE CLEANED: Red label indicating equipment needs cleaning before reuse.

Labels must be durable, tamper-evident, and legible. They shall contain the following information:

Equipment ID
Cleaning date and time
Cleaned by
Verified by (QA)
Hold time (if applicable)

5.2 Labeling After Cleaning

After equipment is cleaned and visually inspected, affix a green “CLEANED” label.
Enter the following manually or via barcode sticker (if system-enabled):
- Date & time of cleaning
- Equipment ID
- Name and signature of operator
QA personnel must review and sign the label before equipment is released for production.

5.3 Label Placement

Affix labels at visible and standard locations:
- Tanks – on manhole cover or near the control panel
- Utensils – on handle or lid
- Pipelines – on nearest valve or joint
- Accessories – on clean tray or container

5.4 Label Status Change

Remove “CLEANED” label immediately upon equipment use and replace with “IN USE.”
Once batch is completed, affix a “TO BE CLEANED” label if cleaning is pending.
Do not reuse labels. Use fresh ones after each cleaning cycle.

5.5 Equipment Cleaning Log

Record label issuance and cleaning status in the Equipment Cleaning Logbook (Annexure-1).
Ensure records include all relevant details and match the physical label on the equipment.

6. Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance
ID: Identification

7. Documents

Equipment Cleaning Logbook (Annexure-1)
Label Sample Templates (Annexure-2)

8. References

ICH Q7 – GMP for APIs
21 CFR Part 211.67 – Equipment Cleaning
WHO TRS 986 – Annex 4: Good Practices for Equipment Use

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Cleaning Logbook

Date	Equipment ID	Cleaning Status	Cleaned By	QA Verified	Label Applied	Remarks
11/04/2025	MXR-ELX-08	Cleaned	Rajesh Kumar	Sunita Reddy	Green Label – CLEANED	Ready for use

Annexure-2: Sample Label Templates

Label Type	Color	Fields on Label
CLEANED	Green	Equipment ID, Date, Time, Cleaned By, Verified By
IN USE	Blue	Equipment ID, Batch No., Start Time
TO BE CLEANED	Red	Equipment ID, Date, Last Used By

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Release	New SOP	QA Head
11/04/2025	2.0	Added hold time and label templates	Audit Requirement	QA Head