Standard Operating Procedure for Prevention of Cross-Contamination in Raw Material Storage
Department | Warehouse / Quality Assurance |
---|---|
SOP No. | SOP/RM/126/2025 |
Supersedes | SOP/RM/126/2022 |
Page No. | Page 1 of 15 |
Issue Date | 23/02/2025 |
Effective Date | 27/02/2025 |
Review Date | 23/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) provides guidelines to prevent cross-contamination during the storage of raw materials in the warehouse, ensuring material integrity and compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals stored in the warehouse.
3. Responsibilities
- Warehouse Personnel: Follow cross-contamination prevention measures during storage and handling of raw materials.
- Warehouse Manager: Supervise storage practices and ensure compliance with this SOP.
- Quality Assurance (QA): Conduct audits, verify storage conditions, and ensure adherence to GMP standards.
4. Accountability
The Warehouse Manager is accountable for implementing contamination prevention measures, while the QA Manager ensures compliance with regulatory and quality standards.
5. Procedure
5.1 Segregation and Storage Practices
- Material Segregation:
- Physically separate raw materials based on their status (Quarantined, Approved, Rejected) and nature (allergenic, hazardous, volatile).
- Store high-risk materials, such as highly potent
APIs or flammable solvents, in dedicated areas with appropriate safety measures.
Document segregation practices in the Material Segregation Log (Annexure-1).
Use of Barriers and Signage:
- Install physical barriers (e.g., partitions, sealed containers) to prevent cross-contact between different materials.
- Clearly label storage areas and racks to indicate the type and status of stored materials.
- Document labeling and barrier use in the Storage Compliance Log (Annexure-2).
5.2 Environmental Controls
- Airflow and Ventilation:
- Ensure proper airflow patterns in the warehouse to prevent airborne contamination between storage zones.
- Use HEPA filters and maintain positive pressure in clean areas, while negative pressure should be maintained in hazardous material zones.
- Document airflow and ventilation checks in the Environmental Control Log (Annexure-3).
- Temperature and Humidity Control:
- Maintain temperature and humidity within specified ranges to prevent material degradation and contamination.
- Monitor environmental conditions twice daily and document in the Temperature and Humidity Log (Annexure-4).
5.3 Handling Procedures to Prevent Cross-Contamination
- Use of Dedicated Equipment:
- Use dedicated tools and equipment (e.g., scoops, containers) for different raw materials to prevent cross-contact.
- Clean and sanitize equipment thoroughly between uses if sharing is unavoidable.
- Document equipment use and cleaning in the Equipment Handling Log (Annexure-5).
- Personal Protective Equipment (PPE):
- Ensure all personnel wear appropriate PPE, such as gloves, masks, and gowns, when handling raw materials.
- Change PPE when switching between different material types to prevent cross-contamination.
- Record PPE compliance in the PPE Monitoring Log (Annexure-6).
5.4 Cleaning and Sanitization
- Routine Cleaning:
- Clean storage racks, floors, and surrounding areas regularly using approved cleaning agents.
- Ensure cleaning is performed after material spills or product changes.
- Document cleaning activities in the Cleaning Log (Annexure-7).
- Sanitization Procedures:
- Sanitize high-touch surfaces and storage containers periodically to reduce microbial contamination risks.
- Use validated sanitizers approved by QA.
- Record sanitization activities in the Sanitization Log (Annexure-8).
5.5 Monitoring, Audits, and Corrective Actions
- Daily Monitoring:
- Warehouse personnel must perform daily checks for compliance with cross-contamination prevention practices.
- Document findings in the Daily Monitoring Log (Annexure-9).
- QA Audits:
- QA will conduct monthly audits to verify compliance with this SOP.
- Record audit findings in the QA Audit Log (Annexure-10).
- Handling Deviations:
- Report deviations, such as improper segregation or cross-contamination incidents, immediately to the Warehouse Manager and QA.
- Document deviations in the Deviation Log (Annexure-11).
- Corrective Actions:
- Investigate root causes of deviations and implement corrective measures like retraining staff or enhancing barriers.
- Document corrective actions in the Corrective Action Log (Annexure-12).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Material Segregation Log (Annexure-1)
- Storage Compliance Log (Annexure-2)
- Environmental Control Log (Annexure-3)
- Temperature and Humidity Log (Annexure-4)
- Equipment Handling Log (Annexure-5)
- PPE Monitoring Log (Annexure-6)
- Cleaning Log (Annexure-7)
- Sanitization Log (Annexure-8)
- Daily Monitoring Log (Annexure-9)
- QA Audit Log (Annexure-10)
- Deviation Log (Annexure-11)
- Corrective Action Log (Annexure-12)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- OSHA Standards for Hazardous Materials Handling
9. SOP Version
Version: 2.0
10. Approval Section
Prepared By | Checked By | Approved By | |
---|---|---|---|
Signature | |||
Date | |||
Name | |||
Designation | |||
Department |
11. Annexures
Annexure-1: Material Segregation Log
Date | Material Name | Status | Storage Area | Performed By |
---|---|---|---|---|
23/02/2025 | API A | Quarantined | Quarantine Zone A | Ravi Kumar |
Annexure-2: Storage Compliance Log
Date | Material Name | Storage Area | Barriers/Labeling Used | Checked By |
---|---|---|---|---|
23/02/2025 | Solvent B | Hazardous Storage Area | Physical Barriers Installed | Sunita Sharma |
Revision History:
Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
---|---|---|---|---|
01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
23/02/2025 | 2.0 | Updated Cross-Contamination Prevention Procedures | Regulatory Compliance | QA Head |