Procedure for Filing Raw Material Inspection Reports
| Department | Quality Control (QC)/Quality Assurance (QA)/Warehouse |
|---|---|
| SOP No. | SOP/Ointment/154 |
| 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 systematic method for filing raw material inspection reports in pharmaceutical manufacturing. Proper documentation of raw material inspections ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and traceability.
2. Scope
This SOP applies to personnel in the Quality Control (QC), Quality Assurance (QA), and Warehouse departments responsible for receiving, inspecting, and filing raw material inspection reports for all incoming materials used in production.
3. Responsibilities
- Warehouse Personnel: Initiates the raw material receiving process and records preliminary observations.
- Quality Control (QC) Analyst: Conducts physical, chemical, and microbiological testing of raw materials and records results.
- QA Officer: Reviews raw material inspection reports for completeness and compliance.
- QA Manager: Approves and ensures proper filing and archiving of inspection records.
4. Accountability
The QA and QC Managers are accountable for ensuring that all raw material inspection reports are filed and maintained in compliance with GMP, FDA, ICH, and WHO regulations.
5. Procedure
5.1 Types of Raw Material Inspection Reports
The following types of reports must be maintained:
- Raw Material Receiving Report: Contains information on material name, supplier details, batch number, and preliminary inspection findings.
- Raw Material Test Report: Includes results of physical, chemical, and microbiological tests conducted on the raw material.
- Certificate of Analysis (CoA): Provided by the supplier, detailing the material’s specifications and test results.
- Raw Material Acceptance/Rejection Report: Documents final decision on whether the material is approved for use or rejected.
5.2 Raw Material Receiving and Preliminary Inspection
- Upon arrival, warehouse personnel must check the material against the purchase order.
- The following parameters must be recorded:
- Material name and description.
- Supplier name and details.
- Batch number and manufacturing/expiry date.
- Quantity received and condition of packaging.
- All details must be documented in the **Raw Material Receiving Report**.
- Warehouse personnel must label the material as **”Quarantine”** until QC testing is completed.
5.3 Raw Material Testing by Quality Control (QC)
- QC personnel must collect representative samples from each batch following the **sampling plan**.
- Tests must be conducted according to predefined specifications, including:
- Physical properties (appearance, odor, color, density).
- Chemical composition (pH, solubility, purity, assay).
- Microbiological testing (bioburden, endotoxin levels, sterility).
- Test results must be recorded in the **Raw Material Test Report**.
- The QC analyst must compare results with the supplier’s Certificate of Analysis (CoA).
- If test results meet acceptance criteria, the material is **approved** and moved to the **Approved Storage Area**.
- If test results do not meet specifications, the material is **rejected** and moved to the **Rejection Area**.
5.4 Review and Approval of Inspection Reports
- QA personnel must review all reports for accuracy and completeness.
- The **Raw Material Acceptance/Rejection Report** must be completed and signed by the QA Manager.
- All reports must be cross-verified with the CoA and supplier documents.
- Any discrepancies or deviations must be investigated and documented.
5.5 Filing and Archiving of Raw Material Inspection Reports
- All raw material inspection reports must be stored in a designated filing system.
- Reports must be categorized by **material name, batch number, and supplier name**.
- Electronic copies of reports should be scanned and backed up in the document management system.
- Retention period:
- Approved materials – **Minimum 5 years**.
- Rejected materials – **Minimum 3 years**.
- QA must ensure records are readily available for audits and regulatory inspections.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CoA – Certificate of Analysis
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- Raw Material Receiving Report Template (Annexure-1)
- Raw Material Test Report Template (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines on Raw Material Testing
- US FDA Guidance on Raw Material Inspection
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 Report Template
| Date | Material Name | Batch No. | Supplier | Quantity | QA Approval |
|---|---|---|---|---|---|
| 01/02/2025 | API-01 | 12345 | Supplier X | 500 kg | Approved |
Annexure-2: Raw Material Test Report Template
| Date | Material Name | Batch No. | Test Conducted | Results | QC Analyst | QA Approval |
|---|---|---|---|---|---|---|
| 02/02/2025 | API-01 | 12345 | Purity Test | 99.8% | John Doe | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Procedure | Improved Documentation | QA Head |