PHARMACEUTICAL INSPECTION WORKFLOW: GMP COMPLIANCE & QUALITY AUDIT MANAGEMENT

Created by ChecklistGuro (https://checklistguro.com)

[ ] Generate Initial Inspection Checklist: Creates the necessary task(s) for the specific inspection audit based on facility scope.
[ ] Assign Inspection Tasks to QA Team: Assigns individual inspection steps and checklists to relevant quality assurance personnel.
[ ] Retrieve Current Facility Inspection Schedule: Fetches scheduled inspections, audit dates, and required checklists for the given location.
[ ] Retrieve Batch Record Data for Review: Gathers necessary raw batch production data to cross-reference with GMP guidelines.
[ ] Record Inspection Findings/Non-Conformances: Allows inspectors to document observations, violations, or deviations found during the audit.
[ ] Update Equipment Calibration Status: Records the pass/fail status and required corrective actions for audited machinery.
[ ] Calculate Overall GMP Score: Aggregates data from multiple entries (e.g., completed checklists, unresolved issues) to generate a final compliance score.
[ ] Generate Comprehensive Audit Report: Compiles all task results, findings, and corrective actions into a final, exportable GMP compliance report.
[ ] Notify Stakeholders of Audit Completion: Automatically notifies required management and department heads that the inspection cycle is finished.
[ ] Send Audit Summary Email: Distributes the finalized inspection summary and action items report to relevant stakeholders.
[ ] Schedule Follow-up Actions/Corrective Actions: Creates follow-up tasks to track the closure of identified deviations (CAPA).
[ ] Aggregate Total Non-Conformance Count: Sums the count of all recorded findings (deficiencies) across the inspection scope.
[ ] Urgent Alert: Critical Safety Violation Detected: Sends immediate SMS notification for high-priority, immediate-risk findings.

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