DRUG MASTER FILE (DMF) MANAGEMENT PROCESS

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[ ] Initialize DMF Record: Create a new entry in the DMF Data Model to track the lifecycle of a new Drug Master File.
[ ] Document Compilation Task: Assign a task to the Regulatory Affairs specialist to gather all required technical modules (Module 1-5).
[ ] Update Submission Status: Update the DMF entry status to 'Ready for Submission' once all documents are compiled.
[ ] Regulatory Submission Task: Assign a task to the Submission Lead to upload the dossier to the health authority portal.
[ ] Log Submission Date: Record the actual submission date and receipt number into the DMF Data Model.
[ ] Fetch Pending Amendments: Retrieve all existing entries related to amendments or updates for the specific DMF ID.
[ ] Calculate Review Deadline: Calculate the regulatory response deadline based on the submission date + standard review period (e.g., 90 days).
[ ] Review Deficiency Letter Task: If a deficiency is noted, create a task for the Scientific Lead to analyze the regulatory queries.
[ ] Update DMF Version: Increment the version number in the Data Model when an amendment is processed.
[ ] Notify Stakeholders of Submission: Send an automated email to the Quality Assurance and Manufacturing teams regarding the new submission.
[ ] Aggregate Annual Submission Count: Sum the total number of amendments submitted within the last 12 months for regulatory reporting.
[ ] Generate DMF Compliance Report: Create a summary report showing the current status, upcoming deadlines, and recent changes for all active DMFs.
[ ] Annual Report Preparation: Create a recurring annual task to prepare and submit the mandatory Annual Report.
[ ] Check Expiry/Validity: Retrieve data entries of certificates or licenses associated with the DMF to ensure they are valid.
[ ] Alert: Deadline Approaching: Send an automated email alert to the Regulatory Manager when a review deadline is within 15 days.

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