Standard Operating Procedure for Storage of Non-Pharmacopoeial Grade Raw Materials
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/125/2025 |
| Supersedes | SOP/RM/125/2022 |
| 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) outlines the guidelines for the proper storage of non-pharmacopoeial grade raw materials to ensure material integrity, prevent contamination, and maintain compliance with regulatory requirements.
2. Scope
This SOP applies to all non-pharmacopoeial grade raw materials, including industrial-grade solvents, chemicals, and excipients, stored in the warehouse.
3. Responsibilities
- Warehouse Personnel: Ensure correct storage, labeling, and segregation of non-pharmacopoeial grade raw materials.
- Warehouse Manager: Oversee storage operations and ensure compliance with this SOP.
- Quality Assurance (QA): Conduct inspections and audits to verify compliance with storage requirements.
4. Accountability
The Warehouse Manager is accountable for the implementation of proper storage procedures, while the QA Manager ensures compliance with regulatory and quality standards.
5. Procedure
5.1 Identification and Classification
- Material Identification:
- Identify raw materials that are non-pharmacopoeial grade at the time of receipt.
- Classify materials based on their intended use (e.g., industrial solvents, laboratory reagents).
- Record identified materials in the
Non-Pharmacopoeial Material Register (Annexure-1).
Labeling Requirements:
- Ensure all non-pharmacopoeial materials are labeled clearly with “NON-PHARMACOPOEIAL GRADE” tags.
- Include material name, batch number, expiry date, and storage conditions on the label.
- Document label verification in the Label Compliance Log (Annexure-2).
5.2 Storage Conditions
- Segregated Storage:
- Store non-pharmacopoeial grade raw materials separately from pharmacopoeial grade materials to prevent cross-contamination.
- Use dedicated storage racks or designated storage areas with clear signage.
- Record storage locations in the Storage Location Log (Annexure-3).
- Environmental Control:
- Maintain storage conditions as specified by the manufacturer (e.g., temperature, humidity).
- Monitor environmental conditions daily and document in the Environmental Monitoring Log (Annexure-4).
5.3 Handling and Usage
- Material Handling:
- Use appropriate Personal Protective Equipment (PPE) when handling non-pharmacopoeial grade raw materials.
- Ensure handling equipment is clean and suitable for use with these materials.
- Document handling procedures in the Material Handling Log (Annexure-5).
- Material Issuance:
- Verify that the material is within its expiry date before issuance.
- Record material issuance in the Material Issuance Log (Annexure-6).
5.4 Monitoring and Audits
- Daily Monitoring:
- Warehouse personnel must check the condition of stored materials daily for signs of contamination or degradation.
- Document observations in the Daily Monitoring Log (Annexure-7).
- QA Audits:
- QA will conduct monthly audits of storage areas to ensure compliance with this SOP.
- Record audit findings in the QA Audit Log (Annexure-8).
5.5 Handling Deviations and Corrective Actions
- Deviation Reporting:
- Identify deviations such as incorrect labeling, improper storage, or contamination risks.
- Report deviations immediately to the Warehouse Manager and QA.
- Document deviations in the Deviation Log (Annexure-9).
- Corrective Actions:
- Investigate the cause of deviations and implement corrective actions such as relabeling or retraining staff.
- Document corrective actions in the Corrective Action Log (Annexure-10).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Non-Pharmacopoeial Material Register (Annexure-1)
- Label Compliance Log (Annexure-2)
- Storage Location Log (Annexure-3)
- Environmental Monitoring Log (Annexure-4)
- Material Handling Log (Annexure-5)
- Material Issuance Log (Annexure-6)
- Daily Monitoring Log (Annexure-7)
- QA Audit Log (Annexure-8)
- Deviation Log (Annexure-9)
- Corrective Action Log (Annexure-10)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- OSHA Material Handling and Storage Standards
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Non-Pharmacopoeial Material Register
| Date | Material Name | Batch Number | Expiry Date | Storage Condition |
|---|---|---|---|---|
| 23/02/2025 | Industrial Solvent A | Batch 101 | 23/02/2026 | Room Temperature |
Annexure-2: Label Compliance Log
| Date | Material Name | Label Verified By | Remarks |
|---|---|---|---|
| 23/02/2025 | Industrial Solvent A | Ravi Kumar | Label Verified and Correct |
Annexure-3: Storage Location Log
| Date | Material Name | Storage Area | Placed By |
|---|---|---|---|
| 23/02/2025 | Industrial Solvent A | Non-Pharma Section, Shelf 1 | 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 Storage Procedures | Regulatory Compliance | QA Head |