Single logo
LoginSign Up

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

Get Template

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.

Learn more

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)?

Select the compliance status.

To ensure adherence to regulatory standards for pharmaceutical distribution.
2
What is the process for reviewing batch records?

Provide details about the batch record review process.

To verify that batch records are accurately maintained and reviewed.
3
What is the retention period for pharmaceutical documentation?

Enter the retention period in years.

To ensure that documentation is kept for the required time frame as per regulations.
Min: 1
Target: 5
Max: 10
4
Is the training documentation for staff up to date?

Select the status of the training documentation.

To ensure that all staff are properly trained and documentation is current.
5
Is the electronic data management system compliant with data integrity standards?

Select the data integrity compliance status.

To confirm that electronic data is managed in accordance with integrity and security protocols.
6
What are the procedures for backing up electronic data?

Describe the electronic data backup procedures.

To ensure that there are reliable backup procedures for electronic data.
7
How often are data audits conducted?

Enter the frequency of data audits in months.

To verify that data audits are performed regularly to maintain integrity.
Min: 1
Target: 6
Max: 12
8
Is user access to electronic data adequately controlled?

Select the status of user access control.

To ensure that only authorized personnel have access to sensitive data.
9
Are the Standard Operating Procedures (SOPs) reviewed regularly?

Select the review status of the SOPs.

To ensure that SOPs are kept up to date and reflect current practices.
10
What documentation exists for SOP training for employees?

Provide details about the SOP training documentation.

To verify that employees are trained on the latest SOPs.
11
How many deviations from the SOPs have been recorded in the last year?

Enter the number of SOP deviations.

To assess compliance and identify areas for improvement.
Min: 0
Target: 2
Max: 50
12
Are the SOPs easily accessible to all relevant personnel?

Select the accessibility status of the SOPs.

To ensure that all staff can easily reference the SOPs when needed.
13
Is the quality management system compliant with regulatory requirements?

Select the compliance status of the quality management system.

To ensure that the quality management system meets all necessary regulatory standards.
14
Describe the key components of the quality management system.

Provide a detailed description of the quality management system.

To provide an overview of the quality processes in place.
15
How many quality audits have been conducted in the past year?

Enter the number of quality audits conducted.

To assess the frequency of quality audits and ensure continuous compliance.
Min: 0
Target: 4
Max: 20
16
Are corrective actions from previous audits completed?

Select the status of corrective actions.

To verify that any identified issues have been addressed appropriately.
17
Is the documentation accurately reflecting the activities performed?

Select the accuracy status of the documentation.

To ensure that all documentation is precise and reflects actual practices.
18
What training has been provided regarding documentation practices?

List the training provided on documentation practices.

To confirm that personnel are adequately trained in documentation practices.
19
How many documentation errors have been reported in the last quarter?

Enter the number of documentation errors reported.

To track the frequency of documentation errors and implement improvements.
Min: 0
Target: 3
Max: 100
20
Is there an effective version control system for documentation?

Select the status of the version control system.

To ensure that the latest versions of documents are used and outdated versions are not in circulation.

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