Standard Operating Procedure for Ensuring Regulatory Compliance of Quarantine Storage
Department | Quality Assurance / Quality Control / Warehouse |
---|---|
SOP No. | SOP/RM/088/2025 |
Supersedes | SOP/RM/088/2022 |
Page No. | Page 1 of 15 |
Issue Date | 01/02/2025 |
Effective Date | 05/02/2025 |
Review Date | 01/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the requirements and processes to ensure regulatory compliance for the storage of raw materials in the quarantine area. It aims to maintain material integrity, prevent contamination, and comply with Good Manufacturing Practices (GMP) and regulatory standards.
2. Scope
This SOP applies to all raw materials stored in quarantine, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and temperature-sensitive materials, ensuring they are stored under conditions that meet regulatory guidelines.
3. Responsibilities
- Warehouse Personnel: Ensure proper storage conditions, labeling, and segregation of quarantined materials.
- Quality Control (QC): Monitor the condition of quarantined materials and verify compliance with storage requirements.
- Quality Assurance (QA): Conduct regular audits, approve storage procedures, and ensure adherence to regulatory guidelines.
4. Accountability
The QA Manager is accountable for ensuring regulatory compliance of quarantine storage. The Warehouse Manager is responsible for the physical storage and condition of quarantined materials.
5. Procedure
5.1 Regulatory Requirements for Quarantine Storage
- Applicable Guidelines:
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- WHO GMP Guidelines for Storage and Distribution of Pharmaceuticals
- Key Compliance Areas:
- Controlled access to quarantine areas
- Proper labeling and segregation of quarantined materials
- Environmental monitoring (temperature, humidity)
- Documentation and traceability of all stored materials
5.2 Storage Area Requirements
- Designated Quarantine Area:
- Quarantine storage must be physically segregated from approved and rejected materials.
- Clearly label the area with “Quarantine” signs and restrict unauthorized access.
- Environmental Conditions:
- Maintain temperature and humidity within specified limits for each material type.
- Monitor and record environmental conditions using calibrated equipment (Annexure-1).
- Ensure clean and sanitary conditions to prevent contamination.
5.3 Material Handling in Quarantine
- Labeling of Materials:
- Label all quarantined materials with:
- Material Name
- Batch/Lot Number
- “Under Quarantine” status
- Storage conditions (if applicable)
- Label all quarantined materials with:
- Segregation and Identification:
- Segregate materials based on type (APIs, excipients, solvents) and risk category (hazardous, temperature-sensitive).
- Use color-coded tags or labels for easy identification.
5.4 Environmental Monitoring and Control
- Temperature and Humidity Monitoring:
- Monitor environmental conditions daily using data loggers or thermohygrometers.
- Document readings in the Environmental Monitoring Log (Annexure-2).
- Deviation Handling:
- Document temperature or humidity deviations in the Deviation Report (Annexure-3).
- Investigate root causes and implement corrective actions (Annexure-4).
5.5 Documentation and Record-Keeping
- Storage Records:
- Maintain detailed records of all quarantined materials, including batch numbers, storage conditions, and movement logs.
- Document all entries in the Quarantine Storage Log (Annexure-5).
- Audit and Compliance Documentation:
- QA conducts periodic audits of quarantine storage to ensure compliance with SOPs and regulatory requirements.
- Document audit findings and corrective actions in the Audit Log (Annexure-6).
5.6 Training and Compliance Monitoring
- Personnel Training:
- All personnel involved in quarantine storage must be trained on regulatory compliance and SOP requirements.
- Document training completion in the Training Log (Annexure-7).
- Regular Compliance Checks:
- QA conducts regular inspections to verify adherence to quarantine procedures and regulatory guidelines.
- Document compliance checks in the Compliance Check Log (Annexure-8).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- QC: Quality Control
- APIs: Active Pharmaceutical Ingredients
7. Documents
- Environmental Monitoring Equipment Calibration Log (Annexure-1)
- Environmental Monitoring Log (Annexure-2)
- Deviation Report (Annexure-3)
- Corrective Action Log (Annexure-4)
- Quarantine Storage Log (Annexure-5)
- Audit Log (Annexure-6)
- Training Log (Annexure-7)
- Compliance Check Log (Annexure-8)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- WHO GMP Guidelines for Storage and Distribution of Pharmaceuticals
9. SOP Version
Version: 2.0
10. Approval Section
Prepared By | Checked By | Approved By | |
---|---|---|---|
Signature | |||
Date | |||
Name | |||
Designation | |||
Department |
11. Annexures
Annexure-1: Environmental Monitoring Equipment Calibration Log
Date | Equipment Name | Calibration Method | Calibrated By | Verified By (QA) |
---|---|---|---|---|
01/02/2025 | Thermohygrometer | Standard Calibration | Ravi Kumar | Anjali Mehta |
Annexure-2: Environmental Monitoring Log
Date | Time | Temperature (°C) | Humidity (%) | Recorded By |
---|---|---|---|---|
01/02/2025 | 09:00 AM | 25°C | 45% | Sunita Sharma |
Annexure-3: Deviation Report
Date | Deviation Description | Reported By | Investigated By |
---|---|---|---|
02/02/2025 | Temperature Exceeded 30°C | Ajay Singh | Ravi Kumar |
Annexure-4: Corrective Action Log
Date | Deviation Description | Corrective Action | Implemented By | Verified By (QA) |
---|---|---|---|---|
03/02/2025 | Temperature Exceeded 30°C | Calibrated HVAC System | Ravi Kumar | Anjali Mehta |
Annexure-5: Quarantine Storage Log
Date | Material Name | Batch Number | Storage Location | Stored By |
---|---|---|---|---|
01/02/2025 | API-X | API-X-2025-001 | Quarantine Area A | Ravi Kumar |
Annexure-6: Audit Log
Date | Audit Type | Findings | Corrective Actions Taken | Audited By |
---|---|---|---|---|
04/02/2025 | Quarantine Compliance Audit | Temperature Monitoring Gap | Updated Monitoring SOP | Anjali Mehta |
Annexure-7: Training Log
Date | Training Topic | Trainer | Attendee Name | Signature |
---|---|---|---|---|
05/02/2025 | Quarantine Storage Compliance | QA Manager | Sunita Sharma |
Annexure-8: Compliance Check Log
Date | Compliance Check | Findings | Corrective Actions | Checked By |
---|---|---|---|---|
06/02/2025 | Environmental Monitoring | Humidity Spike | Adjusted HVAC Settings | Anjali Mehta |
Revision History:
Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
---|---|---|---|---|
01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
01/02/2025 | 2.0 | Updated Storage and Monitoring Procedures for Regulatory Compliance | Regulatory Compliance | QA Head |