Compliance with Regulatory Requirements – Standard Operating Procedure

1) Purpose

To establish guidelines for ensuring adherence to regulatory requirements governing procurement activities within the pharmaceutical purchase department.

2) Scope

This SOP applies to all procurement processes and activities that impact compliance with applicable regulatory standards and guidelines.

3) Responsibilities

Regulatory Affairs Department: Responsible for interpreting and communicating regulatory requirements.
Procurement Team: Responsible for implementing procurement practices in accordance with regulatory standards.

4) Procedure

4.1) Regulatory Landscape Assessment:
4.1.1) Identify relevant regulatory requirements and standards applicable to procurement activities (e.g., FDA, EMA, ICH).
4.1.2) Regularly monitor updates and changes to regulatory guidelines impacting procurement.

4.2) Supplier Qualification:
4.2.1) Establish criteria for supplier qualification based on regulatory compliance (e.g., GMP, GDP).
4.2.2) Conduct audits or assessments to verify supplier compliance with regulatory requirements.

4.3) Contractual Compliance:
4.3.1) Include regulatory clauses and requirements in procurement contracts and agreements.
4.3.2) Ensure suppliers adhere to regulatory standards throughout the contract duration.

4.4) Documentation and Reporting:
4.4.1) Maintain accurate records and documentation demonstrating compliance with regulatory requirements.
4.4.2) Generate reports and summaries for regulatory inspections or audits as