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.

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.

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