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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

Pharmaceuticals

Standard

ICH Q9, EU GMP Chapter 4, FDA 21 CFR Part 211, WHO GMP

Workspaces

Pharmaceutical manufacturing plants

Occupations

Quality Assurance Managers
Document Control Specialists
Compliance Officers
Production Managers
Quality Control Analysts

Documentation Practices Audit

(0 / 5)

1
What percentage of documentation meets GDP requirements?

Enter a percentage value.

To quantify compliance with Good Documentation Practices.
Min: 0
Target: 100
Max: 100
2
When was the last review of the key documentation conducted?

Select the date of the last review.

To ensure that documentation is regularly reviewed and updated.
3
How are ALCOA+ principles implemented in documentation practices?

Explain how each principle is adhered to.

To assess compliance with ALCOA+ principles in documentation.
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4
Describe the process for ensuring data integrity in documentation.

Provide a detailed explanation.

To evaluate the measures taken to maintain data integrity.
5
Is there a documented procedure for document control?

Select compliance status.

To ensure proper management of documents throughout their lifecycle.
6
What is the accuracy rate of the records maintained?

Enter a percentage value.

To assess the quality of record-keeping practices.
Min: 0
Target: 100
Max: 100
7
When was the last compliance audit for record-keeping conducted?

Select the date of the last audit.

To ensure regular compliance checks are performed.
8
Explain the record retention policy in place.

Provide a detailed explanation of the retention policy.

To evaluate the adequacy of record retention practices.
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9
Is there an audit trail for electronic records?

Indicate whether an audit trail exists.

To ensure traceability and accountability in record-keeping.
10
Are electronic records maintained in compliance with regulations?

Select the compliance status.

To verify adherence to standards for electronic records management.
11
Provide an overview of the corrective action process in place.

Explain the corrective action process in detail.

To assess the effectiveness of the corrective action procedures.
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12
When was the last review of the quality system conducted?

Select the date of the last review.

To ensure that the quality system is regularly evaluated and updated.
13
What percentage of staff has completed required training on quality systems?

Enter a percentage value.

To ensure staff are adequately trained in quality system procedures.
Min: 0
Target: 100
Max: 100
14
Describe the change control process in the quality system.

Provide a detailed explanation of the change control process.

To evaluate how changes are managed within the quality system.
15
Is the quality system documentation complete and up-to-date?

Select the completeness status.

To ensure all necessary documents are current and available for review.
16
What is the current non-conformance rate for GMP practices?

Enter the non-conformance rate as a percentage.

To assess the level of compliance with GMP standards.
Min: 0
Target: 0
Max: 100
17
When was the last GMP compliance audit conducted?

Select the date of the last audit.

To ensure that GMP compliance audits are performed regularly.
18
Describe the procedures for handling deviations in GMP practices.

Provide a detailed explanation of the deviation handling procedures.

To evaluate how deviations are managed to maintain compliance.
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19
Is there a regular review process for Standard Operating Procedures (SOPs)?

Indicate whether a review process exists.

To ensure SOPs are kept current and effective.
20
Are training records for GMP compliant practices available and accessible?

Select the availability status.

To ensure that all personnel are adequately trained in GMP practices.
21
What is the rate of corrections made to documents over the past year?

Enter the correction rate as a percentage.

To assess the frequency of document inaccuracies.
Min: 0
Target: 0
Max: 100
22
When was the last accuracy review conducted for key documents?

Select the date of the last accuracy review.

To ensure that documentation accuracy is evaluated regularly.
23
Is there a process in place to review changes made to documents?

Indicate whether a change review process exists.

To ensure all changes are reviewed and approved before implementation.
24
Describe the mechanism for reporting errors in documentation.

Provide a detailed explanation of the error reporting mechanism.

To evaluate how errors are managed and reported.
25
Is the accuracy of the documentation regularly assessed?

Select the accuracy assessment status.

To ensure that documentation reflects the correct information.

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

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