Standard Operating Procedure for Documentation of Raw Material Issuance in ERP System
| Department | Warehouse / Production / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/200/2025 |
| Supersedes | SOP/RM/200/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 05/05/2025 |
| Effective Date | 12/05/2025 |
| Review Date | 05/05/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for documenting raw material issuance in the Enterprise Resource Planning (ERP) system to ensure traceability, accuracy, and compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all warehouse, production, and quality assurance personnel involved in the documentation, verification, and issuance of raw materials using the ERP system in pharmaceutical manufacturing.
3. Responsibilities
- Warehouse Staff: Accurately document raw material issuance in the ERP system.
- Production Supervisor: Verify ERP entries before material usage in manufacturing.
- Quality Assurance (QA) Team: Oversee ERP documentation compliance and conduct audits.
4. Accountability
The Warehouse Manager is accountable for the correct documentation of raw material issuance in the ERP system. The Production Supervisor ensures the accuracy of ERP records before usage, while the QA Manager ensures compliance through regular audits.
5. Procedure
5.1 Preparation for ERP Documentation
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Review of Batch Manufacturing Record (BMR):
ERP System Access:
- Review the BMR to identify the required raw materials and quantities for issuance.
- Record the review in the BMR Review Log (Annexure-1).
- Ensure authorized personnel have access to the ERP system for documentation.
- Document system access in the ERP Access Log (Annexure-2).
5.2 Documentation Process in ERP
- Entering Raw Material Details:
- Log into the ERP system and navigate to the raw material issuance module.
- Enter details such as material name, batch number, quantity, and date of issuance.
- Document the entries in the ERP Entry Log (Annexure-3).
- Verification of ERP Entries:
- Cross-check ERP entries against the BMR to ensure accuracy.
- Document verification in the ERP Verification Log (Annexure-4).
5.3 Handling Discrepancies in ERP Documentation
- Identification of Discrepancies:
- Report any discrepancies in ERP entries immediately to QA for review.
- Document discrepancies in the ERP Discrepancy Log (Annexure-5).
- Corrective Actions:
- Implement corrective actions for discrepancies as recommended by QA.
- Document corrective actions in the ERP Corrective Action Log (Annexure-6).
5.4 Approval and Finalization
- Final Approval of ERP Entries:
- Ensure all ERP entries are reviewed and approved by the Warehouse Manager and QA.
- Document final approval in the ERP Approval Log (Annexure-7).
- Finalization of Issuance:
- Confirm the issuance of materials based on verified ERP entries before transferring to production.
- Document the final issuance in the Final Issuance Log (Annexure-8).
5.5 Training and Compliance Monitoring
- Training on ERP Documentation:
- Conduct regular training sessions for warehouse and production staff on ERP documentation procedures.
- Document training sessions in the ERP Training Log (Annexure-9).
- Compliance Audits:
- QA personnel conduct periodic audits to ensure ERP documentation compliance.
- Record audit findings in the Compliance Audit Log (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- ERP: Enterprise Resource Planning
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
7. Documents
- BMR Review Log (Annexure-1)
- ERP Access Log (Annexure-2)
- ERP Entry Log (Annexure-3)
- ERP Verification Log (Annexure-4)
- ERP Discrepancy Log (Annexure-5)
- ERP Corrective Action Log (Annexure-6)
- ERP Approval Log (Annexure-7)
- Final Issuance Log (Annexure-8)
- ERP Training Log (Annexure-9)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO Guidelines on GMP for Pharmaceutical Products
- FDA Guidance on ERP System Management in Pharmaceutical Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: BMR Review Log
| Date | BMR Number | Reviewed By | Remarks |
|---|---|---|---|
| 05/05/2025 | BMR-23456 | Ravi Kumar | Reviewed and Approved |
Annexure-2: ERP Access Log
| Date | User ID | Access Level | Authorized By |
|---|---|---|---|
| 05/05/2025 | USR001 | Full Access | Neha Verma |
Annexure-3: ERP Entry Log
| Date | Material Name | Batch Number | Quantity (kg) | Entered By |
|---|---|---|---|---|
| 05/05/2025 | Paracetamol API | BN-78901 | 20 kg | Kiran Patel |
Annexure-4: ERP Verification Log
| Date | Material Name | Batch Number | Verified By |
|---|---|---|---|
| 05/05/2025 | Paracetamol API | BN-78901 | Amit Joshi |
Annexure-5: ERP Discrepancy Log
| Date | Discrepancy Identified | Description | Reported By |
|---|---|---|---|
| 05/05/2025 | Incorrect Batch Entry | Batch number mismatch in ERP system | QA Team |
Annexure-6: ERP Corrective Action Log
| Date | Issue | Corrective Action Taken | Performed By |
|---|---|---|---|
| 05/05/2025 | Incorrect Batch Entry | Corrected the ERP entry | Warehouse Staff |
Annexure-7: ERP Approval Log
| Date | Material Name | Batch Number | Approved By |
|---|---|---|---|
| 05/05/2025 | Paracetamol API | BN-78901 | QA Head |
Annexure-8: Final Issuance Log
| Date | Material Name | Batch Number | Issued To |
|---|---|---|---|
| 05/05/2025 | Paracetamol API | BN-78901 | Production Department |
Annexure-9: ERP Training Log
| Date | Employee Name | Training Topic | Trainer | Remarks |
|---|---|---|---|---|
| 05/05/2025 | Neha Verma | ERP Documentation Procedures | QA Manager | Completed Successfully |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Implementation | QA Head |
| 05/05/2025 | 2.0 | Included detailed ERP documentation and discrepancy handling procedures. | Regulatory Update | QA Head |