Standard Operating Procedure for Material Movement Record Maintenance
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/024/2025 |
| Supersedes | SOP/ELX/024/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define the standard procedure for maintaining accurate, timely, and traceable records of raw material movement within the Elixir Department, ensuring transparency and compliance with GMP and audit requirements.
2. Scope
This SOP applies to all raw materials issued, transferred, returned, or disposed of during dispensing operations in the Elixir manufacturing facility.
3. Responsibilities
- Dispensing Operator:
- Record each material movement activity immediately upon completion.
- Warehouse Staff:
- Ensure proper material reconciliation and documentation in designated registers or software.
- QA Officer:
- Verify records during batch release, audits, and periodic reviews.
4. Accountability
The Head of Warehouse and Head of QA are accountable for the integrity and accuracy of material movement records.
5. Procedure
5.1 Movement Recording Format
- Use the standardized Material Movement Record (Annexure-1) or electronic inventory system.
- Each record entry must include:
- Date and Time
- Material Name and
Code
Batch Number
Quantity Moved
Source Location
Destination Location
Movement Type (Issue/Return/Transfer/Disposal)
Done By and Verified By
5.2 Recording Material Issue
- When materials are issued from the warehouse for dispensing:
- Record issuance details with reference to batch manufacturing record (BMR).
- Cross-verify issued quantity against Material Requisition Slip.
5.3 Recording Material Return
- After dispensing, return unused raw materials to quarantine or approved stock.
- Record returned quantities and condition (sealed/intact) with appropriate labeling.
5.4 Recording Inter-Department Transfer
- For any internal transfer between storage rooms, document in the movement log.
- Track containers with location codes and ensure reconciliation is maintained.
5.5 Recording Disposal
- Expired, damaged, or rejected materials must be recorded in the Disposal Log.
- Obtain approval from QA and Head of Warehouse prior to destruction.
5.6 Review and Correction
- QA reviews all material movement records weekly or batch-wise.
- In case of error, strike through with a single line, sign, date, and enter correct data adjacent to the original.
5.7 Electronic Record Maintenance (If Applicable)
- Use validated software with audit trail capabilities.
- Ensure backups are maintained as per IT SOPs.
- Only authorized users may access and modify records.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
7. Documents
- Material Movement Record (Annexure-1)
- Material Requisition Slip
- Disposal Log
8. References
- 21 CFR Part 211 – Subpart E
- WHO GMP Guidelines – Materials Management
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Material Movement Record
| Date | Material Name | Batch No. | Qty | From | To | Type | By | Verified |
|---|---|---|---|---|---|---|---|---|
| 13/04/2025 | Sucrose | SC-0425 | 25 kg | Main Store | Dispensing | Issue | Rajesh Kumar | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial Version | New SOP | QA Head |
| 13/04/2025 | 2.0 | Added electronic record section and disposal tracking | System Upgrade | QA Head |