Procedure for Receiving Raw Materials in Ointment Manufacturing
| Department | Warehouse/Quality Control |
|---|---|
| SOP No. | SOP/Ointment/001 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a consistent process for receiving raw materials used in ointment manufacturing. This procedure ensures compliance with Good Manufacturing Practices (GMP), prevents contamination, and maintains material integrity.
2. Scope
This SOP applies to all raw materials received at the warehouse and used in ointment production. It includes initial inspection, documentation verification, sampling, quarantine, and approval.
3. Responsibilities
- Warehouse Personnel: Responsible for receiving and inspecting raw materials.
- Quality Control (QC) Personnel: Responsible for sampling and testing materials.
- Production Supervisor: Ensures compliance with GMP and company procedures.
- Quality Assurance (QA) Officer: Approves raw materials for use in manufacturing.
4. Accountability
The Warehouse Manager is accountable for ensuring that all received raw materials meet the required specifications before use in ointment manufacturing.
5. Procedure
5.1 Receiving Raw Materials
- Ensure that the raw materials are received from approved suppliers.
- Check the delivery vehicle for cleanliness and compliance with transportation conditions.
- Verify that the shipment corresponds to the Purchase Order (PO) and delivery documents.
5.2 Visual Inspection and Documentation Verification
- Inspect packaging for damage, leaks, or contamination.
- Check the batch number, expiry date, and manufacturer’s label.
- Ensure that Certificates of Analysis (CoA) and Material Safety Data Sheets (MSDS) are provided.
- Document all received materials in the Raw Material Receiving Register.
5.3 Sampling and Quality Control
- QC personnel will collect samples following the approved sampling plan.
- Perform initial tests such as organoleptic assessment (color, odor, texture).
- Submit the samples for chemical, microbiological, and physical testing.
- Ensure that all test results comply with specifications before approval.
5.4 Quarantine and Labeling
- Place raw materials in the quarantine area until QC approval is received.
- Use proper labeling: “Quarantine,” “Approved,” or “Rejected” based on test results.
- Ensure that rejected materials are moved to the designated area for disposal or return.
5.5 Approval and Release
- QA personnel review test reports and approve materials for use.
- Update records in the inventory management system.
- Move approved materials to the designated storage area.
5.6 Documentation and Record-Keeping
- Maintain detailed records of received materials, test reports, and approvals.
- Ensure traceability by recording batch numbers, supplier details, and test results.
- Archive records as per regulatory requirements.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CoA – Certificate of Analysis
- MSDS – Material Safety Data Sheet
7. Documents
- Raw Material Receiving Register (Annexure-1)
- Sampling Log (Annexure-2)
8. References
- ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- WHO GMP Guidelines
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
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 Register
| Date | Material Name | Batch Number | Supplier | PO Number | QC Approval |
|---|---|---|---|---|---|
| 01/02/2025 | Material A | Batch 12345 | Supplier X | PO-56789 | Approved |
| 02/02/2025 | Material B | Batch 67890 | Supplier Y | PO-98765 | Rejected |
Annexure-2: Sampling Log
| Date | Material Name | Batch Number | Sampling Personnel | QC Test Performed | Result |
|---|---|---|---|---|---|
| 01/02/2025 | Material A | Batch 12345 | John Doe | Moisture Test | Pass |
| 02/02/2025 | Material B | Batch 67890 | Jane Smith | Microbial Test | Fail |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By | Page No. | Ref. Point No. | Details of Revision |
|---|---|---|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head | All | All | Created new SOP |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head | All | All | Revised to meet new documentation standards |