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:

1. Inspect the external condition of the shipment for any visible damage (e.g., punctures, tears, leaks).
2. Check the packing list and Purchase Order (PO) for accuracy, ensuring the number of items matches the shipment.
3. Verify that all required documents, including the Certificate of Analysis (CoA), Safety Data Sheets (SDS), and batch records, are present and valid.
4. 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:

1. Check the packaging for any visible signs of tampering, contamination, or damage.
2. If packaging is damaged, move the material to a designated area and inform QA.
3. Sample materials based on the approved sampling plan, ensuring all containers are represented.
4. 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:

1. If materials pass all inspections and tests, the QA team approves them for storage and production.
2. Materials are moved to the designated storage area and are labeled as “Approved” for use in capsule manufacturing.
3. 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:

1. Update the Raw Material Receiving Log with details such as material name, batch number, PO number, vendor name, and any discrepancies.
2. Ensure all documents (e.g., CoA, SDS) are filed appropriately, either physically or electronically.
3. 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:

1. Label the materials as “Rejected” and segregate them from the usable stock.
2. Notify Procurement to initiate a return, replacement, or credit process with the supplier.
3. 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

1. Raw Material Receiving Log (Annexure-1)
2. Certificate of Analysis (CoA) (Annexure-2)
3. 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