Standard Operating Procedure for Handling and Storing Documents Related to Raw Material Receiving

Department	Warehouse / Quality Assurance / Procurement
SOP No.	SOP/RM/041/2025
Supersedes	SOP/RM/041/2022
Page No.	Page 1 of 15
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for handling, storing, and maintaining documents related to raw material receiving. Proper documentation is critical for ensuring traceability, regulatory compliance, and efficient management of raw material inventory. This SOP ensures:

• Systematic handling and organization of raw material receiving documents.
• Secure storage and easy retrieval of documents for audits and inspections.
• Compliance with Good Manufacturing Practices (GMP) and regulatory documentation standards.
• Clear responsibilities for maintaining document integrity across departments.

2. Scope

This SOP applies to all documents generated and received during the raw material receipt process, including:

• Purchase Orders (POs), Delivery Notes, and Invoices.
• Certificates of Analysis (CoAs) and Material Safety Data Sheets (MSDS).
• Raw Material Receiving Registers and Sampling Logs.
• Deviation Reports, Non-Conformance Logs, and Corrective Action Records.

3. Responsibilities

• Warehouse Personnel:
  • Ensure all receiving documents are accurately completed and forwarded to Quality Assurance (QA) for review.
  • Maintain physical copies of receiving logs and other documentation for easy access.
• Quality Assurance (QA) Team:
  • Review and verify the accuracy of all raw material receiving documents.
  • Store finalized documents in a secure, organized manner for audit purposes.
  • Ensure compliance with regulatory and company documentation standards.
• Procurement Department:
  • Provide necessary supplier documents, such as POs, invoices, and compliance certificates, to Warehouse and QA.
  • Maintain electronic records of supplier documents and coordinate with QA for document audits.

4. Accountability

The Warehouse Manager is responsible for ensuring that all raw material receiving documents are complete and accurate before submission to QA. The QA Manager holds the authority to verify, approve, and securely store all raw material receiving documents in compliance with GMP requirements. The Procurement Manager is accountable for maintaining supplier records and ensuring that documentation provided to the Warehouse and QA is accurate and up-to-date.

5. Procedure

5.1 Collection of Raw Material Receiving Documents

1. Document Collection During Material Receipt
   1. Warehouse personnel collect and organize all documents related to the raw material receipt process, including:
      • Purchase Orders (POs) and Delivery Notes.
      • Supplier Invoices and Packing Lists.
      • Certificates of Analysis (CoAs) and Material Safety Data Sheets (MSDS).
      • Raw Material Receiving Register (Annexure-1) and Sampling Log (Annexure-2).
   2. Ensure that all documents are checked for accuracy, completeness, and consistency with the received materials.
2. Initial Review by Warehouse Personnel
   1. Verify that:
      • Supplier information matches the purchase order.
      • Quantities received correspond with the delivery note and PO.
      • All required documentation is included and complete.
   2. Forward all documents to QA for further review and approval.

5.2 Review and Approval of Documents

1. QA Verification of Documentation
   1. QA reviews the collected documents to ensure compliance with GMP and regulatory requirements:
      • Verify that CoAs and MSDS are complete, accurate, and correspond to the received materials.
      • Check that deviation reports and corrective actions, if applicable, are documented and resolved.
   2. Sign and date all approved documents and return a copy to the Warehouse for record-keeping.
2. Handling Discrepancies in Documentation
   1. If discrepancies are identified during the QA review:
      • Document the discrepancies in the Deviation Report (Annexure-3).
      • Coordinate with Procurement to resolve issues with suppliers.
      • Ensure that corrected documentation is submitted before final approval of the material.

5.3 Storage and Archiving of Documents

1. Physical Storage of Documents
   1. Store all approved physical documents in a secure, designated location within the QA department.
   2. Organize documents in labeled folders based on material type, batch number, and supplier information.
   3. Ensure that documents are protected from environmental damage, such as moisture or excessive heat.
2. Electronic Storage of Documents
   1. Procurement and QA teams maintain electronic copies of all raw material receiving documents:
      • Scan and store documents in secure, password-protected digital folders.
      • Ensure that electronic files are organized using consistent naming conventions for easy retrieval.
      • Back up electronic records regularly to prevent data loss.
3. Document Retention and Disposal
   1. Retain all raw material receiving documents for a minimum of five years or as per regulatory requirements.
   2. Dispose of outdated documents following QA approval and in accordance with company document destruction policies.

6. Abbreviations

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

7. Documents

1. Raw Material Receiving Register (Annexure-1)
2. Sampling Log (Annexure-2)
3. Deviation Report (Annexure-3)
4. Purchase Orders (POs) and Delivery Notes
5. Certificates of Analysis (CoAs) and Material Safety Data Sheets (MSDS)

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	Documents Collected	Verification Status	Remarks
01/02/2025	ABC Chemicals	API-X	X-2025-001	PO-12345	100 kg	PO, CoA, MSDS	Verified	Accepted
02/02/2025	XYZ Pharma	Excipient-Y	Y-2025-002	PO-67890	200 kg	PO, CoA (Incomplete)	Pending QA Review	Quarantined

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 Correction

Annexure-3: Deviation Report

Deviation Number	Date	Supplier Name	Material Name	Description of Deviation	Root Cause	Corrective Action	Status
DEV-001/2025	01/02/2025	ABC Chemicals	API-X	None	N/A	N/A	Closed
DEV-002/2025	02/02/2025	XYZ Pharma	Excipient-Y	Incomplete CoA	Supplier Error	Supplier Resubmitted Corrected CoA	Closed

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 handling and storing documents related to raw material receiving.
01/02/2025	2.0	Added Electronic Storage Protocols	Standardization of Document	QA Head	All	All	Included electronic storage and backup procedures for raw material documents.