The Importance of Maintaining Source Documents Throughout the Regulatory Submission Process

In the pharmaceutical industry, precision and accuracy are paramount, especially when it comes to regulatory submissions. Every piece of information submitted to regulatory bodies undergoes rigorous scrutiny, and any discrepancies can result in delays or even rejection of the submission. One crucial aspect that is often overlooked is the maintenance of source documents throughout the lifecycle of an application.

What are Source Documents?

Source documents are the original records that contain the original information used to create regulatory submission documents. For instance, when submitting a Chemistry, Manufacturing, and Controls (CMC) dossier for an eCTD submission to FDA, we submit PDF versions of the documents. However, the Word documents used to create these PDFs are the source documents.

Why Maintain Source Documents?

• Accuracy and Consistency: Source documents ensure that the information presented in the submission is accurate and consistent. Any updates or revisions made to the submission can be traced back to these original documents, ensuring transparency and reliability.

• Future Updates and Amendments: Regulatory requirements are dynamic and can change over time. Maintaining source documents allows for easier updates and amendments to submissions as new data becomes available or regulations evolve.

• Gain Efficiency: Maintaining source documents means you don't have to start from scratch when you're starting a new IND for the same compound, or getting ready to move from the IND stage to the NDA stage. 

• Audit Trail: Source documents serve as an audit trail, providing a clear record of all changes made during the preparation of the submission. This can be invaluable during regulatory inspections or audits.

• Risk Mitigation: By maintaining source documents, companies can mitigate the risk of data loss or corruption that could occur when relying solely on final submission documents.

Best Practices for Source Document Management

• Version Control: Implement a robust version control system to track changes made to source documents, such as an electronic Data Management System (eDMS). This ensures that the most current and accurate information is always used in submissions.

• Secure Storage: Store source documents in secure, backed-up locations to prevent data loss and unauthorized access. Consider using cloud-based storage solutions with encryption capabilities for added security.

• Documentation: Maintain detailed documentation of any changes, updates, or revisions made to source documents. This documentation should include the date, nature of the change, and the individual responsible for making the change. (This is especially important for documents like protocols and subsequent amendments, where FDA often requests a tracked changes version and expects a Summary of Changes.)

• Regular Reviews: Conduct regular reviews of source documents to ensure they remain up-to-date with current regulatory requirements and industry standards.

• Contract Considerations: If you're working with a CRO, make sure your contract stipulates that you receive copies of all source documents as they're finalized so you're prepared if your needs change and you part ways.

Conclusion

Maintaining source documents throughout the submission process is not just a best practice; it's a necessity. It ensures accuracy, facilitates future updates, increases efficiency, and provides a robust audit trail, all of which are critical for successful regulatory submissions in the pharmaceutical industry. If you need to create your source documents (either with templates to start or by retroactively recreating them based on submission PDFs), The Sugar Water Operations Team can help. We offer a variety of services to help you manage the operational aspects of the submission lifecycle, from Quality Management & Assurance to Regulatory Operations. Find out more at www.thesugarwateroperationsteam.com, and contact us to discuss how we can design a right-size solution for your next milestone.