Standard Operating Procedure for Receiving Raw Materials for Capsule Manufacturing
| Department | Capsule Manufacturing |
|---|---|
| SOP No. | SOP/CM/001/2025 |
| Supersedes | SOP/CM/001/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
To define the procedure for receiving raw materials used in capsule manufacturing, ensuring they meet quality, safety, and regulatory standards before processing.
2. Scope
Applies to all raw materials, including excipients and APIs, received for capsule manufacturing. Covers inspection, verification, and acceptance/rejection procedures.
3. Responsibilities
- Warehouse Personnel: Handle offloading, storage, and initial inspection of materials.
- QC Team: Inspect materials and verify documentation for compliance with specifications.
- QA Team: Oversee the release of materials and ensure compliance with regulatory standards.
- Procurement Department: Ensure timely delivery and correct documentation for raw materials.
4. Accountability
The Warehouse Manager ensures the SOP is followed. The QA Manager has final approval over material release and compliance verification.
5. Procedure
5.1 Pre-Arrival Coordination
Before receiving the raw materials, ensure all logistical and documentation steps are prepared:
- Confirm delivery dates with the Procurement Department and notify the Warehouse team.
- Prepare the receiving area by ensuring it is clean, well-organized, and equipped with necessary tools (e.g., scales, temperature monitors).
- Ensure all personnel are aware of the upcoming delivery to handle materials efficiently.
5.2 Offloading and Documentation Check
Upon arrival, follow these steps for unloading and verifying documentation:
- Inspect the external condition of the shipment for any visible damage (e.g., punctures, tears, leaks).
- Check the packing list and Purchase Order (PO) for accuracy, ensuring the number of items matches the shipment.
- Verify that all required documents, including the Certificate of Analysis (CoA), Safety Data Sheets (SDS), and batch records, are present and valid.
- If discrepancies or damage are found, immediately notify the QA and Procurement team for further investigation.
5.3 Visual Inspection and Sampling
Conduct a thorough inspection of the materials and perform sampling as follows:
- Check the packaging for any visible signs of tampering, contamination, or damage.
- If packaging is damaged, move the material to a designated area and inform QA.
- Sample materials based on the approved sampling plan, ensuring all containers are represented.
- QC team tests the samples according to predefined specifications (e.g., moisture content, purity, microbial testing).
5.4 Approval for Storage or Rejection
Once the inspection and sampling are complete, follow these steps:
- If materials pass all inspections and tests, the QA team approves them for storage and production.
- Materials are moved to the designated storage area and are labeled as “Approved” for use in capsule manufacturing.
- If materials fail to meet the required specifications, they are rejected and moved to the rejection area for further action (e.g., return to vendor).
5.5 Documentation and Record-Keeping
Ensure all necessary documentation is completed and maintained for future reference:
- Update the Raw Material Receiving Log with details such as material name, batch number, PO number, vendor name, and any discrepancies.
- Ensure all documents (e.g., CoA, SDS) are filed appropriately, either physically or electronically.
- Document all rejection or non-conformance cases in the Discrepancy Report (Annexure-3), detailing the issue and corrective actions taken.
5.6 Handling Rejected Materials
If raw materials are rejected, take the following actions:
- Label the materials as “Rejected” and segregate them from the usable stock.
- Notify Procurement to initiate a return, replacement, or credit process with the supplier.
- Document the rejection in the Discrepancy Report and communicate with the supplier to resolve the issue.
6. Abbreviations
- SOP: Standard Operating Procedure
- CoA: Certificate of Analysis
- SDS: Safety Data Sheet
- PO: Purchase Order
- QC: Quality Control
- QA: Quality Assurance
7. Documents
- Raw Material Receiving Log (Annexure-1)
- Certificate of Analysis (CoA) (Annexure-2)
- Discrepancy Report (Annexure-3)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
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 Receiving Log
| Date | Vendor Name | Material Name | Batch Number | Quantity Received | PO Number | Remarks |
|---|---|---|---|---|---|---|
| 01/02/2025 | ABC Suppliers | Capsule Material A | Batch 12345 | 500 kg | PO-98765 | No Damage |
Annexure-2: Certificate of Analysis (CoA)
| Material | Batch Number | Test Parameter | Specification | Result | Test Date |
|---|---|---|---|---|---|
| Capsule Material A | Batch 12345 | Purity | ≥ 99% | 99.5% | 01/02/2025 |
Annexure-3: Discrepancy Report
| Incident Date | Material Name | Batch Number | Description | Corrective Action |
|---|---|---|---|---|
| 02/02/2025 | Capsule Material B | Batch 67890 | Missing CoA | Contacted Vendor for CoA |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Document Format and Updates | Standardization | QA Head |