SOP Guide for Pharma

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

Auditor

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.
See also  Elixir Department: SOP for Cleaning Between Product Changeover - V 2.0

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

  1. Define the campaign limit (e.g., 3 or 5 batches) in the product-specific master manufacturing record (MMR) or validation protocol.
  2. 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

  1. 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.
  2. Do not use any detergent or solvent unless final batch is completed or residue is excessive.
  3. Maintain a record of intermediate cleaning after each batch (Annexure-1).

5.3 Final Cleaning After Campaign End

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

5.4 Hold Time Monitoring

  1. 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).
  2. Document the downtime and any cleaning activity in the Hold Time Log.

5.5 Documentation

  1. Record batch number, date, equipment ID, and cleaning status after each batch.
  2. 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

  1. Campaign Cleaning Logbook (Annexure-1)
  2. Cleaning Validation Protocol
  3. 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
Exit mobile version