Standard Operating Procedure for Ensuring GMP Compliance in Raw Material Storage
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/124/2025 |
| Supersedes | SOP/RM/124/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 22/02/2025 |
| Effective Date | 26/02/2025 |
| Review Date | 22/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the processes required to ensure compliance with Good Manufacturing Practices (GMP) in the storage of raw materials, thereby maintaining material integrity and preventing contamination.
2. Scope
This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other materials stored in the warehouse.
3. Responsibilities
- Warehouse Personnel: Implement GMP practices during storage activities and report any deviations.
- Warehouse Manager: Ensure adherence to GMP guidelines, conduct routine inspections, and address non-compliance issues.
- Quality Assurance (QA): Conduct audits, verify compliance with GMP, and approve corrective actions for deviations.
4. Accountability
The Warehouse Manager is accountable for ensuring GMP compliance in raw material storage, while the QA Manager is responsible for verifying adherence to regulatory standards and maintaining documentation.
5. Procedure
5.1 Storage Requirements Under GMP
- Material Segregation:
- Segregate raw materials based on status: Quarantined, Approved, and Rejected.
- Ensure physical
barriers or designated storage areas for each material category to prevent cross-contamination.
Document segregation practices in the Segregation Log (Annexure-1).
Temperature and Humidity Control:
Labeling Requirements:
- Maintain storage conditions according to manufacturer recommendations and GMP guidelines.
- Monitor temperature and humidity twice daily and record in the Environmental Monitoring Log (Annexure-2).
- Ensure all raw materials are clearly labeled with material name, batch number, status, and expiry date.
- Use color-coded labels for easy identification of material status.
- Document label verification in the Labeling Compliance Log (Annexure-3).
5.2 Material Handling Procedures
- Good Handling Practices:
- Use appropriate Personal Protective Equipment (PPE) when handling raw materials.
- Ensure that handling equipment is clean and suitable for use with raw materials.
- Document handling practices in the Material Handling Log (Annexure-4).
- FIFO and FEFO Implementation:
- Follow First-In, First-Out (FIFO) and First-Expiry, First-Out (FEFO) principles for raw material usage.
- Ensure materials with the earliest expiry date are used first to prevent wastage.
- Document FIFO/FEFO activities in the FIFO/FEFO Log (Annexure-5).
5.3 Cleaning and Maintenance
- Routine Cleaning:
- Clean storage areas and equipment regularly using approved cleaning agents.
- Ensure no residue or contaminants are present after cleaning.
- Document cleaning activities in the Cleaning Log (Annexure-6).
- Maintenance Procedures:
- Inspect storage racks, HVAC systems, and monitoring equipment monthly for wear or malfunction.
- Conduct repairs promptly and document in the Maintenance Log (Annexure-7).
5.4 Monitoring and Audits
- Daily Monitoring:
- Warehouse personnel must check storage conditions daily for compliance with GMP.
- Document observations in the Daily Monitoring Log (Annexure-8).
- QA Audits:
- QA will conduct monthly audits to ensure raw material storage practices comply with GMP.
- Document audit results in the QA Audit Log (Annexure-9).
5.5 Handling Deviations and Corrective Actions
- Deviation Reporting:
- Identify deviations such as incorrect storage conditions, improper labeling, or cross-contamination risks.
- Immediately report deviations to the Warehouse Manager and QA.
- Document deviations in the Deviation Log (Annexure-10).
- Corrective Actions:
- Investigate the cause of deviations and implement corrective actions such as re-labeling, re-segregating materials, or retraining staff.
- Document corrective actions in the Corrective Action Log (Annexure-11).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- FIFO: First-In, First-Out
- FEFO: First-Expiry, First-Out
7. Documents
- Segregation Log (Annexure-1)
- Environmental Monitoring Log (Annexure-2)
- Labeling Compliance Log (Annexure-3)
- Material Handling Log (Annexure-4)
- FIFO/FEFO Log (Annexure-5)
- Cleaning Log (Annexure-6)
- Maintenance Log (Annexure-7)
- Daily Monitoring Log (Annexure-8)
- QA Audit Log (Annexure-9)
- Deviation Log (Annexure-10)
- Corrective Action Log (Annexure-11)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- ISO 14644 – Cleanrooms and Associated Controlled Environments
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Segregation Log
| Date | Material Name | Status | Storage Area | Performed By |
|---|---|---|---|---|
| 22/02/2025 | API A | Approved | Shelf 1, Row A | Ravi Kumar |
Annexure-2: Environmental Monitoring Log
| Date | Time | Temperature (°C) | Humidity (%) | Recorded By |
|---|---|---|---|---|
| 22/02/2025 | 08:00 AM | 22°C | 45% | Sunita Sharma |
Annexure-3: Labeling Compliance Log
| Date | Material Name | Label Verified By | Remarks |
|---|---|---|---|
| 22/02/2025 | Excipients B | Anjali Mehta | Label Correct and Compliant |
Annexure-4: Material Handling Log
| Date | Material Name | Handling Activity | Performed By |
|---|---|---|---|
| 22/02/2025 | API C | Transferred to Quarantine Area | Ravi Kumar |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 22/02/2025 | 2.0 | Updated GMP Compliance Procedures | Regulatory Compliance | QA Head |