Standard Operating Procedure for Verifying Regulatory Compliance for Imported Raw Materials

Department	Quality Assurance / Regulatory Affairs / Procurement / Warehouse
SOP No.	SOP/RM/044/2025
Supersedes	SOP/RM/044/2022
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 verifying the regulatory compliance of imported raw materials. Compliance verification is essential to ensure that all imported materials meet international and national regulatory standards, including those set by the FDA, EMA, WHO, and other relevant authorities. This SOP ensures:

• Systematic verification of documentation for all imported raw materials.
• Compliance with international and national regulations for raw material imports.
• Timely identification of non-compliance issues and implementation of corrective actions.
• Coordination between Regulatory Affairs, Quality Assurance (QA), Procurement, and Warehouse teams.

2. Scope

This SOP applies to all raw materials imported into the facility, including active pharmaceutical ingredients (APIs), excipients, chemicals, solvents, and packaging materials. It includes:

• Verification of import documentation, including Certificates of Analysis (CoA), Certificates of Origin (CoO), and regulatory approvals.
• Inspection and documentation of imported raw materials at the point of receipt.
• Responsibilities for handling non-compliant materials and initiating corrective actions.

3. Responsibilities

• Regulatory Affairs Team:
  • Verify that all imported raw materials comply with international and national regulatory requirements.
  • Ensure that suppliers provide valid regulatory documentation, including import permits and certificates.
  • Coordinate with QA to resolve any compliance issues identified during material receipt.
• Quality Assurance (QA) Team:
  • Review import documentation provided by Regulatory Affairs and Procurement.
  • Ensure that all imported raw materials meet internal quality standards and regulatory requirements.
  • Approve or reject imported raw materials based on compliance verification.
• Procurement Department:
  • Ensure that suppliers provide complete and accurate regulatory documentation for all imported materials.
  • Coordinate with Regulatory Affairs and QA to resolve documentation discrepancies.
• Warehouse Personnel:
  • Inspect imported raw materials upon receipt for compliance with shipping and labeling regulations.
  • Segregate and quarantine non-compliant materials pending QA review.

4. Accountability

The Regulatory Affairs Manager is responsible for verifying the compliance of imported raw materials with all applicable regulatory requirements. The QA Manager holds the authority to approve or reject imported materials based on compliance verification. The Procurement Manager is accountable for ensuring that suppliers provide accurate and complete regulatory documentation, while the Warehouse Manager is responsible for the proper handling of imported materials upon receipt.

5. Procedure

5.1 Pre-Shipment Compliance Verification

1. Review of Supplier Documentation
   1. Regulatory Affairs reviews supplier documentation before shipment, including:
      • Valid Certificates of Analysis (CoA) and Certificates of Origin (CoO).
      • Import permits and licenses, if required.
      • Supplier compliance with international standards such as GMP, FDA, EMA, or WHO guidelines.
   2. Ensure that all regulatory documentation is up-to-date and complete before approving the shipment.
2. Coordination with Procurement and Suppliers
   1. Procurement ensures that suppliers provide all necessary documentation before shipment.
   2. Coordinate with Regulatory Affairs to address any missing or incomplete documentation before shipment approval.

5.2 Verification Upon Material Receipt

1. Initial Inspection by Warehouse Personnel
   1. Upon receipt of imported raw materials, Warehouse personnel perform the following checks:
      • Verify that shipping labels, packaging, and documentation match the purchase order (PO) and regulatory requirements.
      • Inspect materials for signs of damage or contamination during transport.
      • Segregate non-compliant or damaged materials and move them to the quarantine area.
2. Documentation Review by QA and Regulatory Affairs
   1. QA and Regulatory Affairs review the following documents upon receipt:
      • Certificates of Analysis (CoA) and Certificates of Origin (CoO).
      • Import permits, licenses, and customs clearance documents.
      • Regulatory compliance certificates (e.g., GMP, FDA, EMA).
   2. Document the verification results in the Imported Material Compliance Log (Annexure-1).

5.3 Handling Non-Compliant Imported Materials

1. Identification and Quarantine of Non-Compliant Materials
   1. If materials are found non-compliant during inspection:
      • Label the materials as “QUARANTINED – NON-COMPLIANT” and move them to the quarantine area.
      • Document the non-compliance in the Non-Compliance Report (Annexure-2).
   2. Notify Regulatory Affairs and Procurement of the non-compliance for further investigation.
2. Supplier Communication and Corrective Actions
   1. Procurement contacts the supplier to address non-compliance issues and requests corrective actions.
   2. Regulatory Affairs ensures that suppliers provide updated documentation or rectifications as required.
   3. Document all corrective actions and supplier communications for audit purposes.

5.4 Final Disposition of Imported Materials

1. Approval or Rejection of Materials
   1. QA and Regulatory Affairs review the compliance status and determine the final disposition:
      • Approved materials are labeled and moved to designated storage areas.
      • Rejected materials are labeled and moved to the rejection area with proper documentation.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis
• CoO: Certificate of Origin
• PO: Purchase Order

7. Documents

1. Imported Material Compliance Log (Annexure-1)
2. Non-Compliance Report (Annexure-2)
3. Certificates of Analysis (CoA) and Certificates of Origin (CoO)
4. Import Permits, Licenses, and Customs Clearance Documents

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
• WHO Guidelines on the Importation of Pharmaceuticals
• Company-Specific Regulatory and Quality 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: Imported Material Compliance Log

Date	Supplier Name	Material Name	Batch Number	PO Number	CoA Verified	Regulatory Compliance	Final Disposition	Remarks
01/02/2025	ABC Chemicals	API-X	X-2025-001	PO-12345	Yes	Compliant	Approved	Released to Storage
02/02/2025	XYZ Pharma	Excipient-Y	Y-2025-002	PO-67890	No	Non-Compliant	Quarantined	Pending Supplier Documentation

Annexure-2: Non-Compliance Report

Report Number	Date	Material Name	Batch Number	Description of Non-Compliance	Corrective Action	Final Disposition	Remarks
NCR-001/2025	01/02/2025	API-X	X-2025-001	None	N/A	Approved	N/A
NCR-002/2025	02/02/2025	Excipient-Y	Y-2025-002	Missing CoA	Supplier to Resubmit CoA	Pending	Awaiting Supplier Response

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 verifying regulatory compliance of imported raw materials.
01/02/2025	2.0	Added Detailed Corrective Action Procedures	Standardization of Document	QA Head	All	All	Enhanced procedures for handling non-compliant imported materials and supplier communication.