Elixir Department: SOP for Cleaning During Campaign Manufacturing – V 2.0

Standard Operating Procedure for Cleaning During Campaign Manufacturing in Elixir Production

Department	Elixir Department
SOP No.	SOP/ELX/177/2025
Supersedes	SOP/ELX/177/2022
Page No.	Page 1 of 10
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To describe the procedure for intermediate cleaning and control during campaign manufacturing of elixir formulations to prevent build-up of residues and maintain equipment suitability throughout the campaign.

2. Scope

This SOP applies to all equipment, utensils, transfer pipelines, and vessels used continuously or intermittently during multi-batch or campaign manufacturing in the Elixir Department, where the same product is manufactured consecutively.

3. Responsibilities

Production Operator:
- Perform equipment cleaning as per campaign schedule and record in the logbook.
Production Supervisor:
- Monitor cleaning frequency and ensure compliance with limits of batch campaign run.
QA Officer:
- Verify visual cleanliness at defined intervals and after final batch.
- Approve continuation of campaign or recommend full cleaning.

4. Accountability

The Production Head is accountable for maintaining batch-to-batch cleaning requirements within campaign runs. The QA Head is responsible for risk-based verification and batch release continuation.

5.

Procedure

5.1 Campaign Justification and Limits

Define the campaign limit (e.g., 3 or 5 batches) in the product-specific master manufacturing record (MMR) or validation protocol.
Campaign runs are permitted only if:
- The same product is manufactured consecutively
- No change in formulation or strength
- Cleaning validation supports extended use

5.2 Cleaning During Campaign

After completion of each batch:
- Drain and rinse tanks and pipelines with purified water to remove residual traces.
- Visually inspect for any adhering residues, discoloration, or unusual deposits.
- Wipe accessible surfaces with lint-free cloth.
Do not use any detergent or solvent unless final batch is completed or residue is excessive.
Maintain a record of intermediate cleaning after each batch (Annexure-1).

5.3 Final Cleaning After Campaign End

Upon completion of last approved batch, perform full cleaning as per validated cleaning SOP (e.g., SOP/ELX/169).
Include detergent washing, rinsing, and swab or rinse sampling for verification.
Only after QA approval, proceed to manufacturing of a different product or strength.

5.4 Hold Time Monitoring

If the equipment is idle for more than the validated hold time during the campaign, perform at least partial cleaning (e.g., hot water rinse).
Document the downtime and any cleaning activity in the Hold Time Log.

5.5 Documentation

Record batch number, date, equipment ID, and cleaning status after each batch.
QA to review cleaning log and provide clearance for continuation or changeover.

6. Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance
MMR: Master Manufacturing Record

7. Documents

Campaign Cleaning Logbook (Annexure-1)
Cleaning Validation Protocol
Hold Time Record

8. References

ICH Q7 – GMP for Active Pharmaceutical Ingredients
21 CFR Part 211.67 – Equipment Cleaning and Maintenance
WHO TRS 986 – GMP Annex: Cleaning Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Campaign Cleaning Logbook

Date	Batch No.	Equipment ID	Visual Check Done By	Cleaning Activity Performed	QA Verification	Remarks
11/04/2025	ELX-20250411-03	MXR-ELX-08	Rajesh Kumar	Water Rinse + Wipe	Sunita Reddy	Approved for next batch

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP Release	New Procedure	QA Head
11/04/2025	2.0	Added hold-time monitoring and clarified cleaning limits	Validation Update	QA Head