Standard Operating Procedure for Cross-Checking Weighed Materials Before Issuance
| Department | Warehouse / Production / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/199/2025 |
| Supersedes | SOP/RM/199/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 04/05/2025 |
| Effective Date | 11/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for cross-checking weighed raw materials before issuance to ensure accuracy, traceability, and compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all warehouse, production, and quality assurance personnel involved in the weighing, verification, and issuance of raw materials for pharmaceutical manufacturing.
3. Responsibilities
- Warehouse Staff: Weigh raw materials accurately and ensure proper documentation.
- Production Supervisor: Cross-check and verify the weighed materials before usage in production.
- Quality Assurance (QA) Team: Oversee compliance with weighing protocols and conduct periodic audits.
4. Accountability
The Warehouse Manager is accountable for ensuring accurate weighing and cross-checking of materials before issuance. The Production Supervisor is responsible for verifying the correctness of materials used in manufacturing, while the QA Manager ensures compliance through audits.
5. Procedure
5.1 Preparation for Material Weighing
- Review of Batch Manufacturing Record (BMR):
- The Warehouse Supervisor reviews the BMR to
identify the required materials and quantities.
Document the review in the BMR Review Log (Annexure-1).
Calibration of Weighing Equipment:
- Ensure that all weighing equipment is calibrated before use.
- Record calibration details in the Equipment Calibration Log (Annexure-2).
5.2 Material Weighing Process
- Weighing of Materials:
- Weigh the materials according to the specified quantity in the BMR using calibrated equipment.
- Document the weighed quantities in the Material Weighing Log (Annexure-3).
- Labeling of Weighed Materials:
- Label each weighed container with the material name, batch number, and weight.
- Record labeling details in the Material Labeling Log (Annexure-4).
5.3 Cross-Checking of Weighed Materials
- Verification of Weighed Materials:
- The Production Supervisor or QA personnel cross-check the weighed materials against the BMR for accuracy.
- Document the verification in the Material Verification Log (Annexure-5).
- Documentation of Discrepancies:
- Any discrepancies between the weighed materials and the BMR should be reported to QA immediately.
- Document discrepancies in the Discrepancy Log (Annexure-6).
5.4 Issuance of Verified Materials
- Approval for Issuance:
- Only materials that have been cross-checked and verified should be issued to the production department.
- Document the issuance in the Material Issuance Log (Annexure-7).
- Handling of Non-Compliant Materials:
- Non-compliant materials should be quarantined and corrective actions should be initiated.
- Document corrective actions in the Corrective Action Log (Annexure-8).
5.5 Training and Compliance Monitoring
- Training on Weighing and Cross-Checking Procedures:
- Conduct regular training sessions for warehouse and production staff on weighing and cross-checking procedures.
- Document training sessions in the Training Log (Annexure-9).
- Compliance Audits:
- QA personnel conduct periodic audits to ensure compliance with weighing and cross-checking procedures.
- Record audit findings in the Compliance Audit Log (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
7. Documents
- BMR Review Log (Annexure-1)
- Equipment Calibration Log (Annexure-2)
- Material Weighing Log (Annexure-3)
- Material Labeling Log (Annexure-4)
- Material Verification Log (Annexure-5)
- Discrepancy Log (Annexure-6)
- Material Issuance Log (Annexure-7)
- Corrective Action Log (Annexure-8)
- 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 Weighing and Verification Procedures
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 |
|---|---|---|---|
| 04/05/2025 | BMR-12345 | Ravi Kumar | Reviewed and Approved |
Annexure-2: Equipment Calibration Log
| Date | Equipment ID | Calibration Status | Calibrated By |
|---|---|---|---|
| 04/05/2025 | WEIGH-001 | Calibrated | Neha Verma |
Annexure-3: Material Weighing Log
| Date | Material Name | Batch Number | Weighed Quantity (kg) | Weighed By |
|---|---|---|---|---|
| 04/05/2025 | Ibuprofen API | BN-67890 | 25 kg | Kiran Patel |
Annexure-4: Material Labeling Log
| Date | Material Name | Label Information | Labeled By |
|---|---|---|---|
| 04/05/2025 | Ibuprofen API | Batch BN-67890, 25 kg | Amit Joshi |
Annexure-5: Material Verification Log
| Date | Material Name | Batch Number | Verified By |
|---|---|---|---|
| 04/05/2025 | Ibuprofen API | BN-67890 | QA Team |
Annexure-6: Discrepancy Log
| Date | Discrepancy Identified | Description | Reported By |
|---|---|---|---|
| 04/05/2025 | Weight Mismatch | Weighed quantity did not match BMR | QA Team |
Annexure-7: Material Issuance Log
| Date | Material Name | Batch Number | Issued To |
|---|---|---|---|
| 04/05/2025 | Ibuprofen API | BN-67890 | Production Department |
Annexure-8: Corrective Action Log
| Date | Issue | Corrective Action Taken | Performed By |
|---|---|---|---|
| 04/05/2025 | Weight Mismatch | Reweighed and corrected the quantity | Warehouse Staff |
Annexure-9: Training Log
| Date | Employee Name | Training Topic | Trainer | Remarks |
|---|---|---|---|---|
| 04/05/2025 | Neha Verma | Weighing and Cross-Checking 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 |
| 04/05/2025 | 2.0 | Added procedures for cross-checking weighed materials. | Regulatory Update | QA Head |