Standard Operating Procedure for Receiving and Inspection of Raw Materials in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/002/2025 |
| Supersedes | SOP/API/002/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To outline a standardized procedure for receiving, verifying, and inspecting raw materials including APIs, excipients, solvents, and other ingredients used in API manufacturing. This ensures all received materials are checked for compliance, free from damage, correctly documented, and quarantined until tested and approved.
2. Scope
This SOP applies to warehouse personnel, quality assurance, and quality control teams involved in the receiving and inspection of raw materials at the API manufacturing facility.
3. Responsibilities
- Warehouse Assistant: Unload, physically inspect, and document incoming raw materials.
- QC Executive: Collect samples for quality testing and confirm packaging integrity.
- QA Officer: Verify documents, approve the quarantine area, and release for sampling.
- Purchase Officer: Coordinate delivery schedules and ensure vendor documents are available.
4. Accountability
The Warehouse Manager and QA Manager are accountable for implementing and monitoring the procedure to ensure GMP compliance and traceability of incoming raw materials.
5. Procedure
5.1 Material Arrival and Unloading
- Verify that the receiving area is clean and designated only for material receipt.
- Check the vehicle cleanliness and integrity before unloading. Reject deliveries if contamination is suspected.
- Use clean forklifts or pallet trucks to unload the material containers.
- Cross-check the delivery challan or invoice against the Purchase Order (PO).
- Note any transit damage, spillage, wet bags, or broken seals in the delivery log.
5.2 Verification of Documents and Material Labeling
- Collect and verify the following documents from the vendor:
- Invoice
- Certificate of Analysis (CoA)
- Material Safety Data Sheet (MSDS)
- GMP declaration or license
- Ensure that each container is properly labeled with:
- Material Name
- Batch Number
- Manufacturer Name
- Manufacturing & Expiry Date
- Net Weight
- Affix a “Quarantine” label (red) with a unique material inward number and date.
5.3 Physical Inspection
- Check packaging integrity: Look for any punctures, swelling, leakages, or corrosion.
- Verify closure seals or tamper-evident tapes for signs of opening.
- Match material quantity received with the PO and invoice.
- Inspect label clarity, legibility, and compliance with predefined format.
5.4 Segregation and Quarantine
- Move received materials to the “Quarantine” storage area.
- Ensure temperature-sensitive materials are stored as per label instruction (e.g., 2–8°C).
- Record all entries in the “Raw Material Receipt Log” (Annexure-1).
- Notify QC to initiate sampling only after QA authorization.
5.5 Handling Discrepancies
- If discrepancies such as wrong batch number, quantity mismatch, or damage are found:
- Do not move materials to quarantine.
- Tag them “On Hold” and place in a designated investigation area.
- Initiate a “Material Discrepancy Form” (Annexure-2).
- Investigate and document outcome with vendor follow-up.
5.6 Approval for Sampling
- QA to review documents and physical inspection checklist.
- Upon satisfactory review, QA shall authorize QC to collect samples.
- Document QA approval in the “Material Inspection Log.”
6. Abbreviations
- QA: Quality Assurance
- QC: Quality Control
- PO: Purchase Order
- SOP: Standard Operating Procedure
- CoA: Certificate of Analysis
- MSDS: Material Safety Data Sheet
7. Documents
- Raw Material Receipt Log (Annexure-1)
- Material Discrepancy Form (Annexure-2)
- Material Inspection Log (Annexure-3)
8. References
- ICH Q7: GMP Guide for Active Pharmaceutical Ingredients
- WHO TRS No. 986 Annex 2
- 21 CFR Part 211.80 – Components, drug product containers, and closures
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | Rajesh Kumar | Sunita Reddy | Manoj Verma |
| Designation | Warehouse Officer | QA Executive | QA Manager |
| Department | API Manufacturing | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Raw Material Receipt Log
| Date | Material | Batch No. | Qty | Supplier | PO No. | Received By |
|---|---|---|---|---|---|---|
| 13/04/2025 | Citric Acid | CA20250413 | 50 kg | ABC Organics | PO-9876 | Rajesh Kumar |
Annexure-2: Material Discrepancy Form
| Date | Material | Issue Observed | Action Taken | Remarks |
|---|---|---|---|---|
| 13/04/2025 | IPA | Broken Drum Seal | Segregated | Vendor informed |
Annexure-3: Material Inspection Log
| Date | Material | Batch | QA Review Status | Sampling Approved | Remarks |
|---|---|---|---|---|---|
| 13/04/2025 | Citric Acid | CA20250413 | Verified | Yes | Ready for QC Sampling |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP | Procedure Establishment | QA Head |
| 13/04/2025 | 2.0 | Included discrepancy handling and annexures | Regulatory alignment | QA Head |