Elixir Department: SOP for Control of Cross-Contamination During Dispensing – V 2.0

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Elixir Department: SOP for Control of Cross-Contamination During Dispensing – V 2.0

Standard Operating Procedure for Control of Cross-Contamination During Dispensing

Department Elixir Department
SOP No. SOP/ELX/019/2025
Supersedes SOP/ELX/019/2022
Page No. Page 1 of 8
Issue Date 13/04/2025
Effective Date 15/04/2025
Review Date 13/04/2026

1. Purpose

To define the standard procedure for minimizing and controlling cross-contamination during the dispensing of raw materials for elixir manufacturing in compliance with GMP and safety standards.

2. Scope

This SOP applies to all dispensing operations in the Elixir Department where active pharmaceutical ingredients (APIs), excipients, flavors, sweeteners, and solvents are weighed or handled prior to manufacturing.

3. Responsibilities

  • Dispensing Operators:
    • Follow gowning and equipment cleaning procedures.
    • Ensure area is clean before initiating dispensing.
  • Warehouse Supervisor:
    • Monitor adherence to controls and ensure segregation of materials.
  • Quality Assurance (QA):
    • Audit processes and verify effectiveness of cleaning and segregation measures.
See also  Elixir Department: SOP for Handling Material Spillage in Dispensing Area - V 2.0

4. Accountability

The Head of Quality Assurance and Head of Production are accountable for implementation and compliance with cross-contamination control measures.

5. Procedure

5.1 General Control Measures

  1. Ensure that only one product or material is handled at a time in the dispensing room.
  2. Follow strict cleaning of equipment, surfaces, and utensils before and after each material dispensing.
  3. Label all in-process containers, scoops, and utensils clearly.
  4. Use separate or color-coded scoops and containers for different types of materials (e.g., API vs. excipient).

5.2 Engineering Controls

  1. Perform dispensing under a validated laminar air flow (LAF) unit for potent or dust-generating materials.
  2. Ensure HVAC system maintains proper air pressure differentials to prevent airborne contamination.
  3. Check that return air grills, HEPA filters, and dust collectors are functional and maintained.

5.3 Procedural Controls

  1. Display “Product in Process” signage during dispensing.
  2. Ensure area cleaning logs and line clearance records are updated before starting new material.
  3. Minimize movement and personnel traffic inside the dispensing area.
  4. Use gloves, masks, and gowns as per gowning SOP.
See also  Elixir Department: SOP for Control and Use of Primary Containers During Dispensing - V 2.0

5.4 Dedicated Equipment and Tools

  1. Maintain separate, labeled equipment (spatulas, scoops, balances) for hazardous or sensitizing agents.
  2. Clean all reusable tools with validated cleaning procedures before re-use.

5.5 Cleaning Verification

  1. Verify cleaning effectiveness using visual inspection and, if applicable, swab sampling.
  2. Record cleaning and verification in the Cleaning Log (Annexure-1).

5.6 Waste and Dust Management

  1. Collect powder residues using a vacuum cleaner with HEPA filters or damp lint-free cloths—do not use dry sweeping.
  2. Dispose of all used gloves, tissues, and disposable items in designated bins lined with polybags.

5.7 Material Segregation

  1. Store each material in a designated area with adequate separation (physical or time-based).
  2. Do not store materials from two different products in the same dispensing area simultaneously.
See also  Elixir Department: SOP for Sampling of Raw Materials for Elixirs - V 2.0

6. Abbreviations

  • SOP: Standard Operating Procedure
  • LAF: Laminar Air Flow
  • HEPA: High Efficiency Particulate Air
  • QA: Quality Assurance
  • HVAC: Heating, Ventilation, and Air Conditioning

7. Documents

  1. Cleaning and Verification Log (Annexure-1)
  2. Dispensing Area Line Clearance Record

8. References

  • WHO TRS 986 Annex 2 – GMP for Non-Sterile Pharmaceuticals
  • 21 CFR Part 211 – Subpart D and E

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning and Verification Log

Date Area/Equipment Cleaned By Verified By Remarks
13/04/2025 Balance Table Rajesh Kumar Sunita Reddy No Residue

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
10/01/2022 1.0 Initial Release New SOP QA Head
13/04/2025 2.0 Added HEPA, swab testing, and signage protocols Regulatory Update QA Head
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