Capsule: SOP for Cross-Contamination Prevention During Dispensing – V 2.0

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Capsule: SOP for Cross-Contamination Prevention During Dispensing – V 2.0

Standard Operating Procedure for Cross-Contamination Prevention During Dispensing

Department Capsule Manufacturing
SOP No. SOP/CM/008/2025
Supersedes SOP/CM/008/2022
Page No. Page 1 of 7
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

To define the procedures for preventing cross-contamination during the dispensing of materials for capsule manufacturing, ensuring product safety and compliance with GMP standards.

2. Scope

This SOP applies to all dispensing activities in capsule manufacturing involving Active Pharmaceutical Ingredients (APIs) and excipients. It outlines the measures taken to prevent cross-contamination of materials during the dispensing process.

3. Responsibilities

  • Manufacturing Personnel: Responsible for following the procedures outlined for preventing cross-contamination during dispensing.
  • Quality Control (QC) Team: Responsible for ensuring that materials meet quality standards and that proper segregation is maintained during dispensing.
  • Warehouse Personnel: Responsible for the safe storage and transport of materials to the dispensing area, ensuring proper segregation of materials that could cause contamination.
  • Quality Assurance (QA) Team: Ensures overall compliance with GMP standards and verifies the effectiveness of cross-contamination prevention measures.

4. Accountability

The Manufacturing Supervisor is accountable for ensuring adherence to this SOP during the dispensing process. The QA Manager is responsible for overseeing cross-contamination prevention practices and addressing any deviations.

5. Procedure

5.1 Preparation for Dispensing

Before starting the dispensing process, ensure the following steps are taken to prevent cross-contamination:

  1. Verify Material

    1. Ensure that the correct material is selected according to the work order and batch record.
    2. Verify that the material is free from contamination and is stored in a designated, segregated area to prevent any potential cross-contamination with other materials.
  2. Prepare Dispensing Area

    1. Ensure that the dispensing area is clean and free from any residues of previous materials. Clean the area thoroughly before starting the process.
    2. Check that all dispensing tools (e.g., scoops, containers) are clean and designated for use with specific materials to prevent cross-contamination.
    3. Ensure that proper ventilation is in place to reduce the risk of airborne contamination.
  3. Personnel Hygiene

    1. Ensure that all personnel handling materials during the dispensing process wear the necessary personal protective equipment (PPE), such as gloves, masks, and lab coats.
    2. Personnel must wash their hands thoroughly before and after handling materials to avoid contamination between dispensing sessions.
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5.2 Segregation of Materials

Ensure the proper segregation of materials to prevent cross-contamination during dispensing:

  1. Physical Separation

    1. Materials should be physically separated in the dispensing area. Use barriers or designated zones to keep materials from mixing.
    2. Ensure that any excipients or APIs with a high risk of cross-contamination are stored in separate containers and clearly labeled.
  2. Color-Coded Containers

    1. Use color-coded containers or bins for different types of materials to easily distinguish between them and minimize the risk of cross-contamination.
    2. Ensure that all containers are properly labeled with material names and batch numbers to avoid any mix-ups.
  3. Dedicated Equipment

    1. Assign specific equipment (e.g., balances, scoops, spatulas) for particular materials to avoid cross-contact between different materials.
    2. Ensure all dispensing equipment is cleaned thoroughly between uses to prevent cross-contamination.

5.3 Handling and Dispensing of Materials

Follow these steps to handle and dispense materials while preventing cross-contamination:

  1. Use of Automated Dispensing Systems

    1. If automated dispensing systems are used, ensure they are calibrated correctly and that they are free from any residues from previous dispensing sessions.
    2. Ensure that automated systems have mechanisms in place to prevent material mix-up, such as automatic segregation of material types.
  2. Manual Dispensing Process

    1. If dispensing is done manually, use clean and dedicated scoops or tools for each material. Avoid using the same tool for different materials unless it has been properly cleaned and decontaminated.
    2. Place materials on clean, designated work surfaces to avoid contamination from other materials or surfaces.
  3. Monitoring of Dispensed Quantities

    1. Ensure that dispensed quantities are double-checked by a second operator to ensure accuracy and prevent errors.
    2. Use automated systems to record the dispensed quantities directly into the system for traceability and monitoring purposes.
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5.4 Cleaning and Decontamination

Regular cleaning and decontamination are essential to prevent cross-contamination:

  1. Cleaning of Dispensing Area

    1. Clean the dispensing area thoroughly after each batch to remove any traces of materials.
    2. Use appropriate cleaning agents that will not react with the materials or cause contamination.
  2. Cleaning of Equipment

    1. After every use, clean all dispensing tools, balances, and containers with appropriate cleaning agents and ensure they are free of any residues before reusing them for other materials.
    2. Maintain cleaning logs to document the cleaning process and ensure compliance.

5.5 Monitoring and Auditing

Regular monitoring and auditing help to ensure adherence to cross-contamination prevention procedures:

  1. Periodic Audits

    1. QA should conduct periodic audits of the dispensing area to ensure compliance with cross-contamination prevention measures.
    2. Audits should include checks for proper segregation of materials, cleaning procedures, and personnel hygiene compliance.
  2. Incident Reporting

    1. Any incidents of cross-contamination should be immediately reported using the Incident Report (Annexure-1) and investigated thoroughly to determine the cause.
    2. Corrective and preventive actions (CAPA) should be documented and implemented to prevent recurrence.

5.6 Documentation and Record-Keeping

Ensure proper documentation for all cross-contamination prevention activities:

  1. Dispensing Log

    1. Document all dispensing activities, including the materials used, the quantities dispensed, and the personnel involved, in the Material Dispensing Log (Annexure-2).
  2. Cleaning and Maintenance Logs

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      1. Document all cleaning and maintenance activities in the Cleaning and Maintenance Logs (Annexure-3), including the materials cleaned, the cleaning agents used, and the cleaning personnel involved.
    1. Incident Reports

      1. All incidents related to cross-contamination should be documented in the Incident Report (Annexure-1), detailing the nature of the incident, its cause, and the corrective actions taken.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • QA: Quality Assurance
    • QC: Quality Control
    • CoA: Certificate of Analysis
    • CAPA: Corrective and Preventive Action
    • PO: Purchase Order
    • API: Active Pharmaceutical Ingredient

    7. Documents

    1. Material Dispensing Log (Annexure-2)
    2. Cleaning and Maintenance Log (Annexure-3)
    3. Incident Report (Annexure-1)

    8. References

    • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
    • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
    • WHO Guidelines for Good Manufacturing Practices

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Incident Report

    Date Material Involved Incident Description Root Cause Corrective Action Preventive Action
    04/02/2025 Excipient-456 Cross-contamination during dispensing Improper segregation of materials Reprocessed material and cleaned dispensing area Implemented color-coded containers for better segregation

    Annexure-2: Material Dispensing Log

    Date Material Name Batch Number Quantity Dispensed Responsible Personnel
    03/02/2025 API-123 Batch 56789 500 g John Doe

    Annexure-3: Cleaning and Maintenance Log

    Date Activity Material/Equipment Cleaned Cleaning Agent Used Personnel
    03/02/2025 Cleaning Weighing Balance Alcohol-based Cleaner Jane Smith

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial Version New SOP Creation QA Head
    01/02/2025 2.0 Updated formatting and added preventive measures Standardization and clarity QA Head
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