Standard Operating Procedure for Verifying Storage Conditions Prior to Raw Material Issuance
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/136/2025 |
| Supersedes | SOP/RM/136/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 29/02/2025 |
| Effective Date | 06/03/2025 |
| Review Date | 29/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the procedures to verify that raw materials are stored under appropriate conditions before being issued for production. This ensures material integrity, quality, 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, which are to be issued for production or quality control.
3. Responsibilities
- Warehouse Personnel: Responsible for checking and documenting storage conditions before raw materials are issued.
- Warehouse Manager: Supervise storage condition verification and ensure compliance with procedures.
- Quality Assurance (QA): Approve issuance after verifying that materials meet storage condition requirements.
4. Accountability
The Warehouse Manager is accountable for ensuring that all raw materials are stored and issued under appropriate conditions. The QA Manager is responsible for verifying compliance with GMP standards.
5. Procedure
5.1 Verification
of Storage Conditions
- Review of Temperature and Humidity Logs:
- Verify that raw materials have been stored within the specified temperature and humidity ranges as per product requirements.
- Review automated monitoring systems or manual logs to confirm compliance.
- Document findings in the Storage Condition Verification Log (Annexure-1).
- Physical Inspection of Storage Areas:
- Inspect the storage area to ensure cleanliness, absence of contamination, and compliance with segregation policies.
- Check for signs of leaks, pest infestation, or other environmental risks.
- Record observations in the Storage Area Inspection Log (Annexure-2).
5.2 Inspection of Raw Material Packaging
- Container Integrity Check:
- Inspect raw material containers for signs of damage, leakage, or tampering.
- Ensure that labels are intact, legible, and include batch numbers, expiry dates, and storage conditions.
- Document container inspection results in the Packaging Inspection Log (Annexure-3).
- Verification of Expiry Dates:
- Ensure that materials being issued are within their expiry dates.
- Cross-verify expiry dates with inventory records and batch documentation.
- Record expiry verification in the Expiry Date Verification Log (Annexure-4).
5.3 Authorization for Issuance
- Preparation of Issuance Request:
- Warehouse personnel must prepare an issuance request after verifying storage conditions.
- The request should include batch numbers, quantity required, and storage verification details.
- Document the request in the Material Issuance Request Log (Annexure-5).
- QA Approval for Issuance:
- QA must review the storage condition verification and approve the issuance of materials.
- Approval should be recorded in the QA Approval Log (Annexure-6).
5.4 Handling Deviations in Storage Conditions
- Identification and Reporting of Deviations:
- Identify any deviations from specified storage conditions, such as temperature excursions, damaged packaging, or expired materials.
- Report deviations immediately to the Warehouse Manager and QA.
- Document deviations in the Deviation Log (Annexure-7).
- Corrective Actions and Quarantine Procedures:
- Quarantine materials that do not meet storage conditions until further evaluation.
- Implement corrective actions based on QA recommendations and document in the Corrective Action Log (Annexure-8).
5.5 Final Issuance and Documentation
- Final Verification and Issuance:
- Perform a final verification before physically issuing the raw materials to the production or laboratory area.
- Ensure materials are transported under appropriate conditions and recorded in the Final Issuance Log (Annexure-9).
- Record Retention:
- Maintain all records related to storage condition verification and material issuance for a minimum of five years.
- Document record retention details in the Record Retention Log (Annexure-10).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- ERP: Enterprise Resource Planning
7. Documents
- Storage Condition Verification Log (Annexure-1)
- Storage Area Inspection Log (Annexure-2)
- Packaging Inspection Log (Annexure-3)
- Expiry Date Verification Log (Annexure-4)
- Material Issuance Request Log (Annexure-5)
- QA Approval Log (Annexure-6)
- Deviation Log (Annexure-7)
- Corrective Action Log (Annexure-8)
- Final Issuance Log (Annexure-9)
- Record Retention Log (Annexure-10)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- ISO 9001:2015 – Quality Management Systems Requirements
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Storage Condition Verification Log
| Date | Material Name | Storage Temperature (°C) | Storage Humidity (%) | Verified By |
|---|---|---|---|---|
| 29/02/2025 | API A | 22 | 45 | Ravi Kumar |
Annexure-2: Storage Area Inspection Log
| Date | Area Inspected | Condition Observed | Corrective Action Required | Inspected By |
|---|---|---|---|---|
| 29/02/2025 | Warehouse Zone A | Clean, no contamination | None | Sunita Sharma |
| 29/02/2025 | Cold Storage Room 2 | Minor condensation on walls | Check dehumidifier | Ravi Kumar |
Annexure-3: Packaging Inspection Log
| Date | Material Name | Container Condition | Label Status | Batch Number | Inspected By |
|---|---|---|---|---|---|
| 29/02/2025 | Excipent B | Intact | Legible | Batch5678 | Neha Verma |
| 29/02/2025 | Solvent C | Dented on one side | Partially torn | Batch1239 | Amit Joshi |
Annexure-4: Expiry Date Verification Log
| Date | Material Name | Batch Number | Expiry Date | Status | Verified By |
|---|---|---|---|---|---|
| 29/02/2025 | API A | Batch1234 | 31/12/2025 | Valid | Priya Singh |
| 29/02/2025 | Solvent C | Batch1239 | 15/02/2025 | Expired | Rajeev Menon |
Annexure-5: Material Issuance Request Log
| Date | Material Name | Batch Number | Quantity Requested | Requested By | Request Status |
|---|---|---|---|---|---|
| 29/02/2025 | API A | Batch1234 | 50 kg | Ravi Kumar | Approved |
| 29/02/2025 | Solvent C | Batch1239 | 20 L | Neha Verma | Rejected (Expired) |
Annexure-6: QA Approval Log
| Date | Material Name | Batch Number | Approval Status | Comments | Approved By |
|---|---|---|---|---|---|
| 29/02/2025 | API A | Batch1234 | Approved | Storage conditions verified | Priya Singh |
| 29/02/2025 | Solvent C | Batch1239 | Rejected | Expired material | Rajeev Menon |
Annexure-7: Deviation Log
| Date | Material Name | Deviation Observed | Reported By | Corrective Action Taken |
|---|---|---|---|---|
| 29/02/2025 | Solvent C | Expired material issued request | Amit Joshi | Material quarantined |
| 29/02/2025 | Excipent B | Container slightly damaged | Neha Verma | Repackaged and labeled |
Annexure-8: Corrective Action Log
| Date | Deviation Description | Corrective Action | Implemented By | Verified By |
|---|---|---|---|---|
| 29/02/2025 | Expired material issued request | Updated ERP system to block expired batch | Ravi Kumar | QA – Priya Singh |
| 29/02/2025 | Damaged packaging | Repackaged in compliant container | Neha Verma | QA – Rajeev Menon |
Annexure-9: Final Issuance Log
| Date | Material Name | Batch Number | Quantity Issued | Issued To | Verified By |
|---|---|---|---|---|---|
| 29/02/2025 | API A | Batch1234 | 50 kg | Production Unit 1 | Sunita Sharma |
Annexure-10: Record Retention Log
| Date | Document Name | Retention Period | Stored By | Location |
|---|---|---|---|---|
| 29/02/2025 | Storage Condition Verification Log | 5 Years | Priya Singh | Document Control Room A |
| 29/02/2025 | Final Issuance Log | 5 Years | Rajeev Menon | Document Control Room B |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 29/02/2025 | 2.0 | Updated to include ERP tracking for expired materials | Compliance with Updated Regulatory Guidelines | QA Head |