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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
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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

Healthcare

Standard

GDP - Good Distribution Practice

Workspaces

Pharmaceutical Distribution Centers

Occupations

Quality Assurance Manager
Document Control Specialist
Regulatory Affairs Coordinator
GDP Compliance Officer
IT Systems Administrator
1
Is the documentation compliant with Good Distribution Practice (GDP)?
2
What is the process for reviewing batch records?
3
What is the retention period for pharmaceutical documentation?
Min: 1
Target: 5
Max: 10
4
Is the training documentation for staff up to date?
5
Is the electronic data management system compliant with data integrity standards?
6
What are the procedures for backing up electronic data?
7
How often are data audits conducted?
Min: 1
Target: 6
Max: 12
8
Is user access to electronic data adequately controlled?
9
Are the Standard Operating Procedures (SOPs) reviewed regularly?
10
What documentation exists for SOP training for employees?
11
How many deviations from the SOPs have been recorded in the last year?
Min: 0
Target: 2
Max: 50
12
Are the SOPs easily accessible to all relevant personnel?
13
Is the quality management system compliant with regulatory requirements?
14
Describe the key components of the quality management system.
15
How many quality audits have been conducted in the past year?
Min: 0
Target: 4
Max: 20
16
Are corrective actions from previous audits completed?
17
Is the documentation accurately reflecting the activities performed?
18
What training has been provided regarding documentation practices?
19
How many documentation errors have been reported in the last quarter?
Min: 0
Target: 3
Max: 100
20
Is there an effective version control system for documentation?

FAQs

The audit should cover SOPs, batch records, training records, temperature logs, cleaning and maintenance records, supplier agreements, and quality management system documentation.

Record retention periods vary depending on the type of document and local regulations, but generally, records should be kept for at least 5 years or 1 year after the expiry date of the product, whichever is longer.

The audit should assess data integrity, access controls, backup procedures, audit trails, and compliance with electronic signature requirements (e.g., 21 CFR Part 11).

This checklist provides a framework for evaluating SOP creation, review, approval, and version control processes, ensuring that SOPs are current, accessible, and effectively implemented.

The audit should review the comprehensiveness of training programs, frequency of training, documentation of attendance and competency assessments, and processes for identifying and addressing training needs.

Benefits of GDP Documentation and Record-Keeping Audit Checklist

Ensures comprehensive evaluation of documentation practices in pharmaceutical distribution

Helps identify gaps in record-keeping processes and systems

Facilitates compliance with GDP documentation requirements

Improves traceability and accountability throughout the supply chain

Supports data integrity and preparedness for regulatory inspections