Standard Operating Procedure for Issuance of Raw Materials for Elixir Production
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/004/2025 |
| Supersedes | SOP/ELX/004/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To describe the procedure for the controlled issuance of approved raw materials from the warehouse to the dispensing and manufacturing areas for the preparation of elixirs, ensuring traceability and compliance with GMP requirements.
2. Scope
This SOP applies to the issuance of all raw materials (APIs, excipients, and solvents) from the approved storage area of the Elixir Department for use in production batches of elixirs.
3. Responsibilities
- Warehouse Staff:
- Verify availability and pick materials as per batch requisition.
- Ensure only approved and released materials are issued.
- Production Supervisor:
- Ensure materials received match the batch manufacturing record (BMR).
- QA Personnel:
- Verify issuance process and perform line clearance where applicable.
4. Accountability
The Head of the Warehouse and Head of QA are accountable for ensuring the traceable and compliant issuance of raw materials for elixir production.
5. Procedure
5.1 Receipt of Requisition
- The production department shall submit a Raw Material Requisition Form (Annexure-1) signed by the production supervisor and approved by the production head.
- The warehouse officer shall check the requisition form for:
- Batch number
- Product name
- Required material names, batch numbers, and quantities
5.2 Verification of Material Availability
- Warehouse staff shall verify the availability of materials in the approved area against the requisition.
- Materials nearing expiry or having special storage conditions must be flagged and managed accordingly.
5.3 Material Issuance
- Pick only materials labeled “Approved” by QA and matching the requisition form.
- Cross-verify:
- Material Name and Code
- Manufacturer/Supplier
- Batch Number
- Quantity Requested vs. Quantity Issued
- Retest Date / Expiry Date
- Transfer materials to the staging/dispensing area using clean and labeled trolleys or pallets.
- Attach the Material Issue Label (Annexure-2) on each container issued.
5.4 Documentation and Recording
- Record details in the Raw Material Issue Logbook (Annexure-3).
- Warehouse staff shall sign and date the issue log and retain a copy of the requisition form.
- Production staff shall verify and sign for receipt of materials.
5.5 Return of Excess Material
- In case of over-issuance or cancellation, return of excess material must be documented using the Material Return Form (Annexure-4).
- Returned material must be:
- Checked for integrity and cleanliness
- Labeled “Returned – Awaiting QA Decision”
- Stored temporarily in the return area until QA decision
5.6 Issuance for Multiple Batches
- Partial issuance of a single batch of material across multiple production batches must be properly recorded and reconciled.
- Each issuance must include a unique entry in the logbook and reference the individual batch numbers.
5.7 Reconciliation and Verification
- After dispensing, material reconciliation must be performed and confirmed by production and warehouse personnel.
- Any discrepancies must be investigated and documented in the Material Reconciliation Sheet (Annexure-5).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
7. Documents
- Raw Material Requisition Form (Annexure-1)
- Material Issue Label (Annexure-2)
- Material Issue Logbook (Annexure-3)
- Material Return Form (Annexure-4)
- Material Reconciliation Sheet (Annexure-5)
8. References
- 21 CFR Part 211 – Subpart E: Control of Components
- WHO GMP Guidelines – Warehouse and Material Handling
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Raw Material Requisition Form
| Product Name | Batch No. | Material Name | Quantity Required | Approved By |
|---|---|---|---|---|
| Elixir A | EA-0425-001 | Sorbitol | 150 L | Production Head |
Annexure-2: Material Issue Label
| Material Name | Code | Batch No. | Issued Qty | Date | Issued By |
|---|---|---|---|---|---|
| Sorbitol | RM-SOR-01 | SB042501 | 150 L | 13/04/2025 | Rajesh Kumar |
Annexure-3: Material Issue Logbook
| Date | Material | Batch No. | Qty Issued | Issued To | Remarks |
|---|---|---|---|---|---|
| 13/04/2025 | Sorbitol | SB042501 | 150 L | Dispensing Area | — |
Annexure-4: Material Return Form
| Date | Material | Batch No. | Returned Qty | Reason | Returned By |
|---|---|---|---|---|---|
| 13/04/2025 | Sorbitol | SB042501 | 10 L | Over issued | Sunita Reddy |
Annexure-5: Material Reconciliation Sheet
| Material | Issued Qty | Used Qty | Returned Qty | Loss | Remarks |
|---|---|---|---|---|---|
| Sorbitol | 150 L | 140 L | 10 L | 0 | Reconciled |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial SOP Release | First Issue | QA Head |
| 13/04/2025 | 2.0 | Format and flow revised for GMP alignment | Compliance and Traceability | QA Head |