Procedure for Verification of Raw Materials Before Dispensing
| Department | Warehouse/Quality Control |
|---|---|
| SOP No. | SOP/Ointment/003 |
| 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 ensure that all raw materials are properly verified before dispensing for ointment manufacturing. This verification process guarantees compliance with Good Manufacturing Practices (GMP) and prevents errors, contamination, or the use of incorrect materials in production.
2. Scope
This SOP applies to all raw materials stored in the warehouse and scheduled for dispensing before ointment production. It includes physical inspection, label verification, batch record confirmation, and documentation review.
3. Responsibilities
- Warehouse Personnel: Ensure raw materials are properly labeled and stored.
- Quality Control (QC) Personnel: Conduct sampling and verification testing.
- Production Supervisor: Approve materials for dispensing after verification.
- Quality Assurance (QA) Officer: Ensure compliance with verification standards.
4. Accountability
The Warehouse Manager is accountable for ensuring that all raw materials pass verification before dispensing to the manufacturing area.
5. Procedure
5.1 Raw Material Identification
- Ensure all raw materials have clear, legible labeling.
- Verify that the material name, batch number, expiry date, and supplier name match the approved specifications.
- Check for any damage, leaks, or contamination of packaging.
5.2 Verification of Documentation
- Review the Certificate
of Analysis (CoA) and ensure it matches the batch number.
Verify that the raw material has undergone QC testing and has an approved status.
Check the Material Safety Data Sheet (MSDS) for handling precautions.
Confirm supplier approval by cross-referencing with the approved vendor list.
5.3 Sampling and Quality Control Check
- Ensure that raw material samples were tested as per the defined sampling plan.
- Verify the QC test results for physical, chemical, and microbial properties.
- Ensure that all test parameters meet the acceptance criteria.
- Document the QC verification details in the Raw Material Verification Log.
5.4 Approval for Dispensing
- QA personnel will review all verification records before authorizing dispensing.
- Materials with discrepancies should be moved to the Quarantine area for further investigation.
- Approved materials will be labeled with “Ready for Dispensing” and transferred to the dispensing area.
5.5 Handling of Non-Conforming Materials
- Any material failing the verification process should be marked as “Rejected.”
- Non-conforming materials should be reported to QA and documented in the Non-Conformance Report (NCR).
- Rejected materials must be segregated and disposed of as per company policy.
5.6 Record-Keeping
- Maintain verification records for all raw materials.
- Ensure all records are signed and dated by the responsible personnel.
- Retain records for the required duration as per regulatory guidelines.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CoA – Certificate of Analysis
- MSDS – Material Safety Data Sheet
- NCR – Non-Conformance Report
7. Documents
- Raw Material Verification Log (Annexure-1)
- Non-Conformance Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q7: Good Manufacturing Practice Guide
- 21 CFR Part 211 – Current Good Manufacturing Practices
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 Verification Log
| Date | Material Name | Batch Number | Verified By | Verification Status | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | Material A | Batch 12345 | John Doe | Approved | Meets specifications |
| 02/02/2025 | Material B | Batch 67890 | Jane Smith | Rejected | Moisture level exceeded |
Annexure-2: Non-Conformance Report (NCR)
| Date | Material Name | Batch Number | Issue Identified | Corrective Action | Reviewed By |
|---|---|---|---|---|---|
| 01/02/2025 | Material B | Batch 67890 | Microbial contamination | Return to supplier | QA Head |
| 02/02/2025 | Material C | Batch 45678 | Label mismatch | Re-label | QA Head |
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 |