GDP Documentation and Record-Keeping Audit Checklist

A specialized checklist for auditing GDP compliance in pharmaceutical documentation and record-keeping practices, focusing on SOPs, batch records, training documentation, and electronic data management systems.

GDP Documentation and Record-Keeping Audit Checklist
by: audit-now
4.7

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About This Checklist

Proper documentation and record-keeping are fundamental to ensuring Good Distribution Practice (GDP) compliance in the pharmaceutical industry. This comprehensive GDP Documentation and Record-Keeping Audit Checklist is designed to help pharmaceutical companies evaluate and improve their documentation processes throughout the distribution chain. By focusing on key areas such as standard operating procedures (SOPs), batch records, training documentation, and electronic data management systems, this checklist enables auditors to thoroughly assess compliance with GDP documentation requirements. Regular use of this checklist can significantly enhance traceability, reduce errors, and improve overall quality management in pharmaceutical distribution operations, ultimately supporting regulatory compliance and product integrity.

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Industry

Pharmaceuticals

Standard

Good Distribution Practice (GDP)

Workspaces

Pharmaceutical Distribution Centers and Corporate Offices

Occupations

Quality Assurance Manager
Document Control Specialist
Regulatory Affairs Coordinator
GDP Compliance Officer
IT Systems Administrator

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