Handling of Import and Export Documentation – Standard Operating Procedure

1) Purpose

To establish a standardized process for handling import and export documentation to ensure compliance with regulatory requirements, facilitate smooth customs clearance, and maintain accurate records within the pharmaceutical purchase department.

2) Scope

This SOP applies to all import and export activities conducted by the pharmaceutical purchase department, including the handling of related documentation.

3) Responsibilities

Logistics Manager: Responsible for overseeing import and export activities and ensuring compliance with documentation requirements.
Logistics Team: Responsible for preparing, reviewing, and maintaining import and export documentation.
Compliance Officer: Responsible for ensuring that all import and export activities comply with regulatory requirements.

4) Procedure

4.1) Import Documentation:
4.1.1) Identify all required documents for the import of goods, including invoices, packing lists, bills of lading, certificates of origin, and any regulatory permits.
4.1.2) Ensure that all documents are accurately prepared and contain the necessary information, such as product descriptions, quantities, values, and relevant codes.
4.1.3) Review documents for completeness and accuracy before submission to customs authorities.

4.2) Export Documentation:
4.2.1) Identify all required documents for the export of goods, including commercial invoices, packing lists, bills of lading, export licenses, and certificates of origin.
4.2.2) Ensure that all documents are accurately prepared and contain the necessary information, such as product descriptions, quantities, values, and relevant codes.
4.2.3) Review documents for completeness and accuracy before submission to customs authorities.

4.3) Regulatory Compliance:
4.3.1) Stay updated on the regulatory requirements for import and export activities in the relevant countries.
4.3.2) Ensure that all documentation complies with the regulatory requirements, including any specific formats, certifications, and approvals.
4.3.3) Coordinate with regulatory bodies to obtain any necessary permits or licenses for the import or export of goods.

4.4) Customs Clearance:
4.4.1) Submit all required documents to the customs authorities in a timely manner to facilitate the clearance process.
4.4.2) Address any queries or issues raised by customs authorities promptly to avoid delays.
4.4.3) Maintain open communication with customs brokers to ensure smooth clearance of goods.

4.5) Record Keeping:
4.5.1) Maintain detailed records of all import and export documentation, including copies of all submitted documents and correspondence with customs authorities.
4.5.2) Ensure that records are organized, securely stored, and easily accessible for audits and future reference.
4.5.3) Retain records for the period specified by regulatory requirements or organizational policies.

4.6) Documentation Review and Audit:
4.6.1) Conduct regular reviews of import and export documentation to ensure ongoing compliance with regulatory requirements.
4.6.2) Perform periodic audits to identify any discrepancies or areas for improvement in the documentation process.
4.6.3) Implement corrective actions as necessary to address any identified issues.

4.7) Training and Awareness:
4.7.1) Provide training to logistics and procurement staff on import and export documentation requirements and procedures.
4.7.2) Ensure that staff are aware of any updates or changes in regulatory requirements.
4.7.3) Promote a culture of compliance and accuracy in handling import and export documentation.

5) Abbreviations, if any

• None

6) Documents, if any

• Commercial Invoices
• Packing Lists
• Bills of Lading
• Certificates of Origin
• Import/Export Licenses
• Regulatory Permits
• Customs Correspondence

7) Reference, if any

Regulatory Guidelines: Customs regulations of relevant countries, FDA CFR Part 211, ISO 9001:2015
Industry Standards: Best practices in handling import and export documentation

8) SOP Version

Version 1.0