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 needed.
4.5) Continuous Improvement:
4.5.1) Implement corrective and preventive actions to address non-compliance issues identified during audits or inspections.
4.5.2) Continuously review and update procurement practices to align with evolving regulatory expectations.
5) Abbreviations, if any
N/A
6) Documents, if any
- Regulatory Guidelines and Standards
- Supplier Audit Reports
- Compliance Certificates
- Regulatory Inspection Reports
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211, EU GMP Annex 11
Industry Standards: ICH Q7, ISO 13485:2016
8) SOP Version
Version 1.0
