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.
Get Template
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.
Learn moreIndustry
Standard
Workspaces
Occupations
Select the compliance status.
Indicate whether an audit trail exists.
Provide a detailed explanation of the retention policy.
Select the date of the last audit.
Enter a percentage value.
Select the completeness status.
Provide a detailed explanation of the change control process.
Enter a percentage value.
Select the date of the last review.
Explain the corrective action process in detail.
Select the availability status.
Indicate whether a review process exists.
Provide a detailed explanation of the deviation handling procedures.
Select the date of the last audit.
Enter the non-conformance rate as a percentage.
Select the accuracy assessment status.
Provide a detailed explanation of the error reporting mechanism.
Indicate whether a change review process exists.
Select the date of the last accuracy review.
Enter the correction rate as a percentage.
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