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Pharmaceutical Good Documentation Practices (GDP) Audit Checklist

A comprehensive audit checklist for evaluating Good Documentation Practices in pharmaceutical operations, ensuring regulatory compliance, and maintaining the highest standards of data integrity and record-keeping.

Pharmaceutical Good Documentation Practices (GDP) Audit Checklist

by: audit-now
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About This Checklist

Good Documentation Practices (GDP) are fundamental to ensuring data integrity, traceability, and regulatory compliance in the pharmaceutical industry. This GDP Audit Checklist is designed to comprehensively evaluate the implementation and adherence to documentation standards across all aspects of pharmaceutical operations. By systematically assessing record creation, maintenance, storage, and retrieval processes, this checklist helps identify potential gaps in documentation practices, ensures compliance with regulatory requirements, and supports the overall quality management system. Effective use of this checklist promotes a culture of accurate and reliable record-keeping, which is crucial for product quality, patient safety, and successful regulatory inspections.

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Industry

Healthcare

Standard

Pharmaceutical Quality Standards

Workspaces

Pharmaceutical Manufacturing Facilities

Occupations

Quality Assurance Managers
Document Control Specialists
Compliance Officers
Production Managers
Quality Control Analysts
1
Is there a documented procedure for document control?
2
Describe the process for ensuring data integrity in documentation.
3
How are ALCOA+ principles implemented in documentation practices?
4
When was the last review of the key documentation conducted?
5
What percentage of documentation meets GDP requirements?
Min: 0
Target: 100
Max: 100
6
Are electronic records maintained in compliance with regulations?
7
Is there an audit trail for electronic records?
8
Explain the record retention policy in place.
9
When was the last compliance audit for record-keeping conducted?
10
What is the accuracy rate of the records maintained?
Min: 0
Target: 100
Max: 100
11
Is the quality system documentation complete and up-to-date?
12
Describe the change control process in the quality system.
13
What percentage of staff has completed required training on quality systems?
Min: 0
Target: 100
Max: 100
14
When was the last review of the quality system conducted?
15
Provide an overview of the corrective action process in place.
16
Are training records for GMP compliant practices available and accessible?
17
Is there a regular review process for Standard Operating Procedures (SOPs)?
18
Describe the procedures for handling deviations in GMP practices.
19
When was the last GMP compliance audit conducted?
20
What is the current non-conformance rate for GMP practices?
Min: 0
Target: 0
Max: 100
21
Is the accuracy of the documentation regularly assessed?
22
Describe the mechanism for reporting errors in documentation.
23
Is there a process in place to review changes made to documents?
24
When was the last accuracy review conducted for key documents?
25
What is the rate of corrections made to documents over the past year?
Min: 0
Target: 0
Max: 100

FAQs

The checklist covers ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available), document control procedures, electronic records compliance, and data integrity measures.

Comprehensive GDP audits should be conducted annually, with more frequent spot checks or targeted audits in critical areas or departments with high documentation volume.

The audit team should include quality assurance specialists, document control experts, IT professionals (for electronic systems), and representatives from various departments to ensure a thorough evaluation of documentation practices across the organization.

The checklist includes specific sections on electronic records and signatures, covering aspects such as system validation, access controls, audit trails, and compliance with 21 CFR Part 11 and Annex 11 requirements.

Yes, the checklist is designed to be applicable to various types of documents including batch records, SOPs, analytical reports, validation protocols, and quality control documents, while maintaining core GDP principles.

Benefits of Pharmaceutical Good Documentation Practices (GDP) Audit Checklist

Ensures compliance with global GMP regulations on documentation

Enhances data integrity and traceability throughout the product lifecycle

Reduces risks associated with poor documentation practices

Improves efficiency in record retrieval and regulatory inspections

Supports consistent and standardized documentation across all departments