discrepancies, damaged goods, or incomplete documentation during receipt.

Documentation and record-keeping responsibilities for all departments involved in the material receipt process.

Supplier communication and corrective action management for issues identified during receipt.

3. Responsibilities

• Procurement Department:
  • Place orders with suppliers and ensure that purchase orders (POs) reflect accurate material specifications, quantities, and delivery requirements.
  • Provide the Warehouse with POs, invoices, Certificates of Analysis (CoAs), and any other relevant supplier documentation before the arrival of materials.
  • Coordinate with suppliers to address shipment delays, discrepancies, or non-compliance issues.
  • Maintain communication with QA and QC teams regarding supplier performance and material compliance.
• Warehouse Personnel:
  • Receive and inspect raw materials based on POs and supplier documentation provided by the Procurement Department.
  • Communicate any discrepancies, damages, or missing documentation to the Procurement Department and QA immediately.
  • Record all material receipt details in the Raw Material Receiving Register (Annexure-1) and maintain proper documentation.
• Quality Assurance (QA) Team:
  • Review supplier documentation for compliance with GMP and regulatory requirements.
  • Approve or reject materials based on inspection findings and documentation verification.
  • Coordinate with Procurement for corrective actions related to supplier performance or material compliance issues.
• Quality Control (QC) Team:
  • Conduct sampling and testing of raw materials as per standard procedures.
  • Report any deviations or non-conformances to QA and coordinate with Procurement for corrective actions if supplier issues are identified.

4. Accountability

The Procurement Manager is responsible for ensuring that all supplier documentation is accurate and provided to the Warehouse and QA teams in a timely manner. The Warehouse Manager is accountable for verifying that received materials match purchase orders and supplier documentation. The QA Manager holds the authority to approve, quarantine, or reject materials based on compliance with supplier requirements and regulatory standards.

5. Procedure

5.1 Pre-Receipt Coordination

1. Order Placement and Supplier Communication
   1. Procurement places orders with suppliers, ensuring that POs clearly specify:
      • Material names, grades, and specifications.
      • Batch numbers, quantities, and packaging requirements.
      • Special handling instructions, if applicable (e.g., temperature control, hazardous material protocols).
   2. Procurement obtains shipment details, including expected delivery dates, shipping methods, and tracking information.
2. Provision of Supplier Documentation
   1. Procurement provides the Warehouse and QA with the following documents before material arrival:
      • Purchase Orders (POs).
      • Invoices and packing lists.
      • Certificates of Analysis (CoAs) and Material Safety Data Sheets (MSDS), if applicable.
      • Any regulatory certificates or supplier compliance documents.
   2. Ensure that all documentation is complete, accurate, and matches the PO details.

5.2 Material Receipt and Inspection

1. Verification of Received Materials
   1. Warehouse personnel receive and unload materials, verifying that:
      • Received quantities match the PO and packing list.
      • Material names, batch numbers, and packaging specifications align with supplier documentation.
      • No physical damage, leakage, or discrepancies are observed.
   2. Record all receipt details in the Raw Material Receiving Register (Annexure-1).
2. Handling Discrepancies and Missing Documentation
   1. If discrepancies (e.g., incorrect quantities, damaged packaging) or missing documentation are identified:
      • Warehouse personnel immediately inform the Procurement Department and QA.
      • Procurement contacts the supplier to resolve the issue and provides updates to the Warehouse and QA teams.
      • QA may quarantine materials until discrepancies are resolved and documentation is verified.

5.3 Documentation and Record-Keeping

1. Recording and Filing Documentation
   1. Warehouse personnel ensure that all receipt details are accurately recorded in the Raw Material Receiving Register.
   2. QA reviews supplier documentation for completeness and compliance, then files it in the raw material documentation archive.
   3. Procurement maintains electronic records of POs, supplier correspondence, and corrective action reports for audit purposes.
2. Managing Non-Conformances and Corrective Actions
   1. QA logs any non-conformances related to material receipt and coordinates with Procurement to implement corrective actions.
   2. Procurement communicates corrective actions to suppliers and ensures that future shipments meet compliance requirements.

5.4 Supplier Performance Monitoring

1. Evaluation of Supplier Compliance
   1. Procurement, QA, and Warehouse teams collaborate to evaluate supplier performance based on:
      • Accuracy and completeness of supplied materials and documentation.
      • Timeliness and reliability of deliveries.
      • Compliance with regulatory and GMP requirements.
   2. Document supplier evaluations and use them to inform future procurement decisions.
2. Addressing Persistent Supplier Issues
   1. If persistent issues with a supplier are identified (e.g., repeated discrepancies, delays, or non-compliance):
      • Procurement escalates the issue to management for review and potential supplier disqualification.
      • QA documents the supplier’s performance in the non-conformance log for future reference.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order
• MSDS: Material Safety Data Sheet
• CoA: Certificate of Analysis

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2)
3. Purchase Orders (POs) and Supplier Invoices
4. Certificates of Analysis (CoAs) and Material Safety Data Sheets (MSDS)
5. Non-Conformance Reports and Corrective Action Logs

8. References

• 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• Company-Specific Procurement, QA, and Warehouse Policies

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	Supplier Name	Material Name	Batch Number	PO Number	Quantity	Inspection Findings	Remarks
01/02/2025	ABC Chemicals	API-X	X-2025-001	PO-12345	100 kg	Packaging Intact, Documentation Verified	Accepted
02/02/2025	XYZ Pharma	Excipient-Y	Y-2025-002	PO-67890	200 kg	Missing CoA, Incorrect Labeling	Quarantined, Pending Supplier Update

Annexure-2: Sampling Log

Date	Material Name	Batch Number	Sampling Personnel	QC Test Performed	Result	Remarks
01/02/2025	API-X	X-2025-001	John Doe	Identity Test	Pass	Approved for Use
03/02/2025	Excipient-Y	Y-2025-002	Jane Smith	Purity Test	Pending	Awaiting Documentation Verification

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 Creation	QA Head	All	All	Established procedures for coordination between Procurement and Warehouse during raw material receipt.
01/02/2025	2.0	Enhanced Supplier Communication Protocols	Standardization of Document	QA Head	All	All	Added detailed steps for handling discrepancies and improving supplier performance monitoring.