Good Documentation Practices (GDP/GDocP)

Good Documentation Practices

Good Documentation Practices (GDP, GDocP) are crucial to ensure that all documentation is accurate, complete, and reliable. Proper documentation supports regulatory compliance, ensures product quality, and provides a reliable record of manufacturing processes.

The FDA does not prescribe exact methods or formats for writing controlled documents in detail, but it does set out broad requirements and expectations that companies must follow. These requirements are designed to ensure that controlled documents are accurate, reliable, and support regulatory compliance. The FDA’s focus is on ensuring that documentation practices meet the principles of Good Manufacturing Practice (GMP), data integrity, and quality assurance.

Integrating ALCOA principles into GDocP provides an even more robust framework for ensuring documentation integrity and compliance in a GMP environment. The ALCOA principles—Attributable, Legible, Contemporaneous, Original, and Accurate—are key to maintaining high standards in documentation.

1. Attributable
   • Description: Each entry in a document must be traceable to the individual who performed the action or recorded the data.
   • Application:
     • Signature and Initials: Ensure that each entry is signed or initialed by the individual responsible for the activity or data entry.
     • Electronic Records: Use electronic signatures or user IDs to attribute actions and entries to specific individuals.
     • Access Controls: Implement systems that record who accessed or modified documents, ensuring clear attribution of changes.
2. Legible
   • Description: Documentation must be clear and readable, ensuring that all information can be easily interpreted.
   • Application:
     • Handwritten Records: Use clear, legible handwriting for paper records. Avoid abbreviations or shorthand that may be unclear.
     • Electronic Records: Ensure that electronic documents are displayed in a readable format and are easily navigable. Regularly check for and resolve any issues with legibility in electronic systems.
3. Contemporaneous
   • Description: Records must be made at the time the activity occurs or as soon as possible thereafter.
   • Application:
     • Real-Time Entry: Document activities, observations, and results as they happen. This reduces the risk of inaccuracies or omissions.
     • Timely Updates: Ensure that any changes or updates to documentation are made promptly after the activity or observation.
4. Original
   • Description: The initial record must be preserved as the original source of information.
   • Application:
     • Original Entries: Maintain original documents without alterations. For paper records, ensure that any corrections are made in accordance with procedures and are clearly indicated.
     • Electronic Records: Use secure systems to preserve original electronic records. Avoid deleting or modifying records without proper documentation of the change.
5. Accurate
   • Description: Documentation must be correct and reflect the true state of affairs.
   • Application:
     • Correct Data Entry: Ensure that all recorded information is accurate and matches the actual observations or results. Double-check entries for accuracy.
     • Error Correction: Correct errors according to established procedures, including striking through incorrect entries and adding correct information without obscuring the original data. Use documented methods for correcting electronic records.

FDA provides comprehensive guidelines and regulations for maintaining data integrity, focusing on ensuring that data is accurate, reliable, and traceable throughout its lifecycle. Companies are expected to implement procedures for creating, reviewing, approving, and revising controlled documents. This includes establishing who is authorized to make changes and how those changes are documented. FDA requires that records be maintained for specified periods and be accessible for review. Companies must develop procedures to ensure records are retained as required and are easily retrievable. By adhering to these guidelines, companies can ensure that their data practices meet regulatory standards and support the integrity of their submissions and quality assessments.