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